Trial Outcomes & Findings for Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT02877134)
NCT ID: NCT02877134
Last Updated: 2025-04-29
Results Overview
The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
388 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2025-04-29
Participant Flow
In participant flow, data is reported in 2 periods, \[Main Study" and "Part II long term extension (LTE) Phase"\] depicts the information for the specified time period as: Part I: Through Week 38 (including safety follow-up); Part II: Through Week 24 for participants who entered the LTE phase and through Week 36 for participants who did not enter the LTE.
Participant milestones
| Measure |
Part I: Placebo
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: Placebo
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Low Dose
Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Middle Dose
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II LTE: Placebo
Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo or JNJ-64304500 middle dose (JNJ-64304500 75 mg SC) at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Low Dose
Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Middle Dose
Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 High Dose
Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: Ustekinumab
Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study (Parts I,II): Up to Week 38
STARTED
|
72
|
73
|
48
|
50
|
49
|
49
|
47
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Parts I,II): Up to Week 38
Placebo Non Responders at Week 12
|
44
|
0
|
31
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Parts I,II): Up to Week 38
COMPLETED
|
58
|
48
|
40
|
35
|
42
|
39
|
42
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Parts I,II): Up to Week 38
NOT COMPLETED
|
14
|
25
|
8
|
15
|
7
|
10
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part II LTE Phase: From Week 24-88
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
22
|
21
|
27
|
24
|
28
|
|
Part II LTE Phase: From Week 24-88
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
17
|
20
|
14
|
24
|
|
Part II LTE Phase: From Week 24-88
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
7
|
10
|
4
|
Reasons for withdrawal
| Measure |
Part I: Placebo
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: Placebo
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Low Dose
Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Middle Dose
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II LTE: Placebo
Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo or JNJ-64304500 middle dose (JNJ-64304500 75 mg SC) at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Low Dose
Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Middle Dose
Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 High Dose
Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: Ustekinumab
Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study (Parts I,II): Up to Week 38
Death
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Parts I,II): Up to Week 38
Lost to Follow-up
|
0
|
4
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Parts I,II): Up to Week 38
Withdrawal by Subject
|
13
|
19
|
5
|
8
|
3
|
6
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Parts I,II): Up to Week 38
Other
|
1
|
1
|
3
|
6
|
4
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part II LTE Phase: From Week 24-88
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part II LTE Phase: From Week 24-88
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
3
|
9
|
3
|
|
Part II LTE Phase: From Week 24-88
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Part II LTE Phase: From Week 24-88
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Part I: Placebo
n=72 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=73 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: Placebo
n=48 Participants
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Low Dose
n=50 Participants
Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Middle Dose
n=49 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
38 years
STANDARD_DEVIATION 13.25 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 13.69 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 11.14 • n=4 Participants
|
37.1 years
STANDARD_DEVIATION 15.04 • n=21 Participants
|
37.2 years
STANDARD_DEVIATION 12.87 • n=10 Participants
|
42 years
STANDARD_DEVIATION 12.62 • n=115 Participants
|
38.5 years
STANDARD_DEVIATION 13.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
174 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
214 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
33 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
343 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
BELGIUM
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
BULGARIA
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
GERMANY
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
|
Region of Enrollment
HUNGARY
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
ITALY
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
|
Region of Enrollment
JAPAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
|
Region of Enrollment
POLAND
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
72 Participants
n=6 Participants
|
|
Region of Enrollment
ROMANIA
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
109 Participants
n=6 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Region of Enrollment
UKRAINE
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
80 Participants
n=6 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
UNITED STATES
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
42 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: The efficacy analyses were based on the Full analysis set (FAS) included all randomized participants in Part 1 who received at least 1 dose of study agent.
The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Outcome measures
| Measure |
Part I: Placebo
n=72 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=73 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8
|
-60.0 units on a scale
Standard Deviation 77.08
|
-103.6 units on a scale
Standard Deviation 93.54
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to number of participants analyzed for this outcome measure.
The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Outcome measures
| Measure |
Part I: Placebo
n=46 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=44 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=47 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=48 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Change From Baseline in the CDAI Score at Week 12
|
-59.2 units on a scale
Standard Deviation 89.51
|
-93.2 units on a scale
Standard Deviation 117.91
|
-72.2 units on a scale
Standard Deviation 92.79
|
-84.3 units on a scale
Standard Deviation 103.28
|
-148.8 units on a scale
Standard Deviation 84.59
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
Clinical Remission was defined as a CDAI score of \<150 point. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Outcome measures
| Measure |
Part I: Placebo
n=48 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=50 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=49 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)
|
14.6 percentage of participants
|
30 percentage of participants
|
18.4 percentage of participants
|
22.4 percentage of participants
|
53.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
Clinical response was defined as a \>=100-point reduction from the baseline CDAI score, or a CDAI score \<150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Outcome measures
| Measure |
Part I: Placebo
n=48 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=50 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=49 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150)
|
22.9 percentage of participants
|
42.0 percentage of participants
|
40.8 percentage of participants
|
30.6 percentage of participants
|
72.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to the number of participants analyzed for this outcome measure.
The PRO-2 score is defined as the sum of the abdominal pain and stool frequency components of the CDAI. PRO-2 scores ranges from 0 to approximately 300, higher score indicates higher disease activity.
Outcome measures
| Measure |
Part I: Placebo
n=46 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=44 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=47 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=48 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=46 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12
|
-28.8 units on scale
Standard Deviation 47.72
|
-46.1 units on scale
Standard Deviation 59.14
|
-39.8 units on scale
Standard Deviation 52.59
|
-42.9 units on scale
Standard Deviation 47.33
|
-70.1 units on scale
Standard Deviation 52.97
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
Clinical Remission was defined as a PRO-2 score of \<75 point.
Outcome measures
| Measure |
Part I: Placebo
n=48 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=50 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=49 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)
|
16.7 percentage of participants
|
32.0 percentage of participants
|
30.6 percentage of participants
|
44.9 percentage of participants
|
53.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
Clinical response was defined as \>=50-point reduction from baseline in PRO-2 or Score or PRO-2 Score \<75.
Outcome measures
| Measure |
Part I: Placebo
n=48 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=50 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=49 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75)
|
31.3 percentage of participants
|
44.0 percentage of participants
|
46.9 percentage of participants
|
49.0 percentage of participants
|
68.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to number of participants analyzed for this outcome measure.
SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Part I: Placebo
n=34 Participants
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=33 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
|
Part II: JNJ-64304500 Middle Dose
n=33 Participants
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=38 Participants
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=36 Participants
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
|---|---|---|---|---|---|
|
Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
|
-2.2 units on a scale
Standard Deviation 6.58
|
-0.7 units on a scale
Standard Deviation 6.47
|
-1.2 units on a scale
Standard Deviation 4.89
|
-2.7 units on a scale
Standard Deviation 6.93
|
-2.6 units on a scale
Standard Deviation 5.32
|
Adverse Events
Part I: Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Part I: Placebo to JNJ-64304500
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Part I: JNJ-64304500
Serious events: 8 serious events
Other events: 38 other events
Deaths: 1 deaths
Part II: Placebo
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Part II: Placebo to JNJ-64304500 Middle Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part II: JNJ-64304500 Low Dose
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Part II: JNJ-64304500 Middle Dose
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part II: JNJ-64304500 High Dose
Serious events: 6 serious events
Other events: 26 other events
Deaths: 1 deaths
Part II: Ustekinumab
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Part II LTE: Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part II LTE: Placebo to JNJ-64304500 Middle Dose
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part II LTE: JNJ-64304500 Low Dose
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part II LTE: JNJ-64304500 Middle Dose
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Part II LTE: JNJ-64304500 High Dose
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Part II LTE: Ustekinumab
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I: Placebo
n=72 participants at risk
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants were followed up for safety up to Week 38.
|
Part I: Placebo to JNJ-64304500
n=44 participants at risk
Participants received placebo SC at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo Q2W through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=73 participants at risk
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. Participants were followed up for safety up to Week 38.
|
Part II: Placebo
n=48 participants at risk
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data up to the time of receiving JNJ- 64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Placebo to JNJ-64304500 Middle Dose
n=31 participants at risk
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Low Dose
n=50 participants at risk
Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Middle Dose
n=49 participants at risk
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 participants at risk
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 participants at risk
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II LTE: Placebo
n=10 participants at risk
Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: Placebo to JNJ-64304500 Middle Dose
n=12 participants at risk
Participants randomized to placebo group and had dose adjustment to JNJ-64304500 middle dose at Week 12 and continued to receive JNJ-64304500 middle dose (JNJ-64304500 75 mg) SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72 in the Part II LTE. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Low Dose
n=21 participants at risk
Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Middle Dose
n=27 participants at risk
Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 High Dose
n=24 participants at risk
Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: Ustekinumab
n=28 participants at risk
Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Peritonitis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.8%
5/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
14.8%
4/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Ileal Perforation
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Ileal Stenosis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Small Intestinal Stenosis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
General disorders
Death
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
12.5%
3/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Device Related Sepsis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Sepsis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
Lipase Increased
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Ovarian Tumour
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Nervous system disorders
Headache
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Reproductive system and breast disorders
Ovarian Cyst Ruptured
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
Other adverse events
| Measure |
Part I: Placebo
n=72 participants at risk
Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants were followed up for safety up to Week 38.
|
Part I: Placebo to JNJ-64304500
n=44 participants at risk
Participants received placebo SC at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo Q2W through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants were followed up for safety up to Week 38.
|
Part I: JNJ-64304500
n=73 participants at risk
Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. Participants were followed up for safety up to Week 38.
|
Part II: Placebo
n=48 participants at risk
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data up to the time of receiving JNJ- 64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Placebo to JNJ-64304500 Middle Dose
n=31 participants at risk
Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Low Dose
n=50 participants at risk
Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 Middle Dose
n=49 participants at risk
Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: JNJ-64304500 High Dose
n=49 participants at risk
Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II: Ustekinumab
n=47 participants at risk
Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
|
Part II LTE: Placebo
n=10 participants at risk
Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: Placebo to JNJ-64304500 Middle Dose
n=12 participants at risk
Participants randomized to placebo group and had dose adjustment to JNJ-64304500 middle dose at Week 12 and continued to receive JNJ-64304500 middle dose (JNJ-64304500 75 mg) SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72 in the Part II LTE. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Low Dose
n=21 participants at risk
Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 Middle Dose
n=27 participants at risk
Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: JNJ-64304500 High Dose
n=24 participants at risk
Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.
|
Part II LTE: Ustekinumab
n=28 participants at risk
Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
3/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
12.3%
9/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.2%
3/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
12.0%
6/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
14.3%
7/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
11.1%
3/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
2.8%
2/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
5.5%
4/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.4%
2/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.2%
3/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.8%
3/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.8%
5/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.0%
2/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.6%
5/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Crohn's Disease
|
5.6%
4/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
6/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
4/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.0%
4/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
14.3%
7/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.3%
2/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
14.8%
4/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
2/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.7%
2/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
3/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.0%
2/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
3/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
4/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
General disorders
Fatigue
|
5.6%
4/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
2/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
General disorders
Pyrexia
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
3/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.2%
3/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.3%
2/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
2/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Influenza
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
5.5%
4/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
3/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.5%
2/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
9.6%
7/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
2/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.0%
3/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
4/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.5%
4/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
11.1%
3/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.2%
5/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
4/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
5.5%
4/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
Lymphocyte Count Decreased
|
2.8%
2/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
9.6%
7/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.0%
2/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.7%
2/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
Platelet Count Increased
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
4/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.3%
2/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
Weight Decreased
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
5.5%
4/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
4/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.1%
2/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
1.4%
1/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.2%
1/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.0%
1/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.8%
1/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
2/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Inflammation
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Nervous system disorders
Headache
|
6.9%
5/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.5%
2/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
11.0%
8/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.2%
3/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.0%
2/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
4/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.2%
4/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.6%
5/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
10.0%
1/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
8.3%
1/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.7%
1/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
7.1%
2/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
6.1%
3/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.2%
1/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/72 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.3%
1/44 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.7%
2/73 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/48 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/31 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
4.0%
2/50 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/49 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
2.1%
1/47 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/10 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/12 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
9.5%
2/21 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/27 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
0.00%
0/24 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
3.6%
1/28 • Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
|
Additional Information
DIRECTOR CLINICAL RESEARCH GI
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER