Trial Outcomes & Findings for A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005) (NCT NCT04996797)
NCT ID: NCT04996797
Last Updated: 2025-08-06
Results Overview
The 3-component Modified Mayo Score (MMS) ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding (RB), and stool frequency (SF) subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
COMPLETED
PHASE2
178 participants
Baseline and Week 12
2025-08-06
Participant Flow
Participants with moderately to severely active ulcerative colitis were enrolled.
Participant milestones
| Measure |
Cohort 1 Tulisokibart
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 2 Tulisokibart
Participants who were CDx+ received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 2 Placebo
Participants who were CDx+ received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
22
|
21
|
|
Overall Study
Treated
|
68
|
67
|
22
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
68
|
67
|
22
|
21
|
Reasons for withdrawal
| Measure |
Cohort 1 Tulisokibart
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 2 Tulisokibart
Participants who were CDx+ received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 2 Placebo
Participants who were CDx+ received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
0
|
0
|
|
Overall Study
Prohibited Medication
|
0
|
1
|
0
|
0
|
|
Overall Study
Ongoing
|
68
|
60
|
22
|
20
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
Baseline Characteristics
BMI is reported for participants who had data available.
Baseline characteristics by cohort
| Measure |
Cohort 1 Tulisokibart
n=68 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=67 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 2 Tulisokibart
n=22 Participants
Participants who were CDx+ received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 2 Placebo
n=21 Participants
Participants who were CDx+ received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.4 Years
STANDARD_DEVIATION 14.4 • n=68 Participants
|
42.2 Years
STANDARD_DEVIATION 16.3 • n=67 Participants
|
38.1 Years
STANDARD_DEVIATION 18.2 • n=22 Participants
|
38.5 Years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
40.6 Years
STANDARD_DEVIATION 15.3 • n=178 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=68 Participants
|
29 Participants
n=67 Participants
|
10 Participants
n=22 Participants
|
4 Participants
n=21 Participants
|
77 Participants
n=178 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=68 Participants
|
38 Participants
n=67 Participants
|
12 Participants
n=22 Participants
|
17 Participants
n=21 Participants
|
101 Participants
n=178 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=68 Participants
|
2 Participants
n=67 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=178 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=68 Participants
|
62 Participants
n=67 Participants
|
19 Participants
n=22 Participants
|
19 Participants
n=21 Participants
|
160 Participants
n=178 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=68 Participants
|
3 Participants
n=67 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=178 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=178 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
1 Participants
n=67 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=178 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=178 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
2 Participants
n=67 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=178 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=68 Participants
|
57 Participants
n=67 Participants
|
17 Participants
n=22 Participants
|
20 Participants
n=21 Participants
|
159 Participants
n=178 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
1 Participants
n=67 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=178 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=68 Participants
|
6 Participants
n=67 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=178 Participants
|
|
CDx+/CDx-
CDx+
|
16 Participants
n=68 Participants
|
16 Participants
n=67 Participants
|
22 Participants
n=22 Participants
|
21 Participants
n=21 Participants
|
75 Participants
n=178 Participants
|
|
CDx+/CDx-
CDx-
|
52 Participants
n=68 Participants
|
51 Participants
n=67 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
103 Participants
n=178 Participants
|
|
Body Mass Index (BMI)
|
25.71 Weight (kg) / [Height (m)]^2
STANDARD_DEVIATION 7.029 • n=68 Participants • BMI is reported for participants who had data available.
|
25.52 Weight (kg) / [Height (m)]^2
STANDARD_DEVIATION 5.033 • n=67 Participants • BMI is reported for participants who had data available.
|
25.11 Weight (kg) / [Height (m)]^2
STANDARD_DEVIATION 4.539 • n=22 Participants • BMI is reported for participants who had data available.
|
26.37 Weight (kg) / [Height (m)]^2
STANDARD_DEVIATION 5.518 • n=20 Participants • BMI is reported for participants who had data available.
|
25.63 Weight (kg) / [Height (m)]^2
STANDARD_DEVIATION 5.845 • n=177 Participants • BMI is reported for participants who had data available.
|
|
Height
|
169.91 Centimeters (cm)
STANDARD_DEVIATION 9.798 • n=68 Participants • Mean height is reported for participants who had data available.
|
172.61 Centimeters (cm)
STANDARD_DEVIATION 9.185 • n=67 Participants • Mean height is reported for participants who had data available.
|
172.31 Centimeters (cm)
STANDARD_DEVIATION 8.729 • n=22 Participants • Mean height is reported for participants who had data available.
|
173.26 Centimeters (cm)
STANDARD_DEVIATION 8.418 • n=20 Participants • Mean height is reported for participants who had data available.
|
171.61 Centimeters (cm)
STANDARD_DEVIATION 9.317 • n=177 Participants • Mean height is reported for participants who had data available.
|
|
Weight
|
73.89 Kilograms (kg)
STANDARD_DEVIATION 19.653 • n=68 Participants
|
76.59 Kilograms (kg)
STANDARD_DEVIATION 18.482 • n=67 Participants
|
74.62 Kilograms (kg)
STANDARD_DEVIATION 14.985 • n=22 Participants
|
79.36 Kilograms (kg)
STANDARD_DEVIATION 14.984 • n=21 Participants
|
75.64 Kilograms (kg)
STANDARD_DEVIATION 18.135 • n=178 Participants
|
|
Duration of Ulcerative Colitis (UC)
|
6.680 Years
STANDARD_DEVIATION 6.3766 • n=68 Participants
|
6.277 Years
STANDARD_DEVIATION 6.1942 • n=67 Participants
|
5.911 Years
STANDARD_DEVIATION 4.0708 • n=22 Participants
|
10.351 Years
STANDARD_DEVIATION 6.8957 • n=21 Participants
|
6.866 Years
STANDARD_DEVIATION 6.2239 • n=178 Participants
|
|
Time Since Symptom Onset
|
7.422 Years
STANDARD_DEVIATION 6.2596 • n=66 Participants • Data for UC symptom onset duration was reported for participants who had data available.
|
6.661 Years
STANDARD_DEVIATION 5.7342 • n=63 Participants • Data for UC symptom onset duration was reported for participants who had data available.
|
6.221 Years
STANDARD_DEVIATION 4.0697 • n=22 Participants • Data for UC symptom onset duration was reported for participants who had data available.
|
11.367 Years
STANDARD_DEVIATION 6.5819 • n=20 Participants • Data for UC symptom onset duration was reported for participants who had data available.
|
7.449 Years
STANDARD_DEVIATION 6.0077 • n=171 Participants • Data for UC symptom onset duration was reported for participants who had data available.
|
|
Extent of UC
Proctosigmoiditis
|
2 Participants
n=68 Participants
|
7 Participants
n=67 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=178 Participants
|
|
Extent of UC
Left sided colitis
|
35 Participants
n=68 Participants
|
28 Participants
n=67 Participants
|
10 Participants
n=22 Participants
|
8 Participants
n=21 Participants
|
81 Participants
n=178 Participants
|
|
Extent of UC
Pancolitis
|
31 Participants
n=68 Participants
|
32 Participants
n=67 Participants
|
10 Participants
n=22 Participants
|
12 Participants
n=21 Participants
|
85 Participants
n=178 Participants
|
|
Current smoking status
Never
|
39 Participants
n=68 Participants
|
45 Participants
n=67 Participants
|
13 Participants
n=22 Participants
|
11 Participants
n=21 Participants
|
108 Participants
n=178 Participants
|
|
Current smoking status
Current
|
9 Participants
n=68 Participants
|
3 Participants
n=67 Participants
|
3 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
15 Participants
n=178 Participants
|
|
Current smoking status
Former
|
20 Participants
n=68 Participants
|
19 Participants
n=67 Participants
|
6 Participants
n=22 Participants
|
10 Participants
n=21 Participants
|
55 Participants
n=178 Participants
|
|
Baseline Endoscopic Score
Score of 2
|
22 Participants
n=68 Participants
|
14 Participants
n=67 Participants
|
3 Participants
n=22 Participants
|
9 Participants
n=21 Participants
|
48 Participants
n=178 Participants
|
|
Baseline Endoscopic Score
Score of 3
|
46 Participants
n=68 Participants
|
53 Participants
n=67 Participants
|
19 Participants
n=22 Participants
|
12 Participants
n=21 Participants
|
130 Participants
n=178 Participants
|
|
Baseline 3-Component Modified Mayo Score
|
6.9 Score
STANDARD_DEVIATION 1.21 • n=68 Participants • The 3-component MMS is reported for all participants who had data available.
|
7.1 Score
STANDARD_DEVIATION 1.10 • n=67 Participants • The 3-component MMS is reported for all participants who had data available.
|
7.1 Score
STANDARD_DEVIATION 1.01 • n=21 Participants • The 3-component MMS is reported for all participants who had data available.
|
6.7 Score
STANDARD_DEVIATION 1.27 • n=21 Participants • The 3-component MMS is reported for all participants who had data available.
|
7.0 Score
STANDARD_DEVIATION 1.16 • n=177 Participants • The 3-component MMS is reported for all participants who had data available.
|
|
Baseline Total Modified Mayo Score
|
9.1 Score
STANDARD_DEVIATION 1.49 • n=68 Participants • Total MMS is reported for all participants who had data available.
|
9.4 Score
STANDARD_DEVIATION 1.29 • n=67 Participants • Total MMS is reported for all participants who had data available.
|
9.3 Score
STANDARD_DEVIATION 1.10 • n=21 Participants • Total MMS is reported for all participants who had data available.
|
8.9 Score
STANDARD_DEVIATION 1.59 • n=21 Participants • Total MMS is reported for all participants who had data available.
|
9.2 Score
STANDARD_DEVIATION 1.39 • n=177 Participants • Total MMS is reported for all participants who had data available.
|
|
Baseline High sensitivity C-reactive protein (hsCRP)
|
10.162 mg/L
STANDARD_DEVIATION 19.1910 • n=67 Participants • Baseline hsCRP is reported for participants who had data available.
|
10.022 mg/L
STANDARD_DEVIATION 13.7709 • n=67 Participants • Baseline hsCRP is reported for participants who had data available.
|
10.754 mg/L
STANDARD_DEVIATION 13.9272 • n=22 Participants • Baseline hsCRP is reported for participants who had data available.
|
10.155 mg/L
STANDARD_DEVIATION 16.6271 • n=21 Participants • Baseline hsCRP is reported for participants who had data available.
|
10.182 mg/L
STANDARD_DEVIATION 16.2430 • n=177 Participants • Baseline hsCRP is reported for participants who had data available.
|
|
Concomitant UC Medication Use
Oral Corticosteroid
|
35 Participants
n=68 Participants
|
38 Participants
n=67 Participants
|
8 Participants
n=22 Participants
|
7 Participants
n=21 Participants
|
88 Participants
n=178 Participants
|
|
Concomitant UC Medication Use
Immunomodulator
|
8 Participants
n=68 Participants
|
11 Participants
n=67 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
21 Participants
n=178 Participants
|
|
Concomitant UC Medication Use
Aminosalicylate
|
44 Participants
n=68 Participants
|
45 Participants
n=67 Participants
|
16 Participants
n=22 Participants
|
14 Participants
n=21 Participants
|
119 Participants
n=178 Participants
|
|
Prior Treatment for UC
Corticosteroid
|
51 Participants
n=68 Participants
|
58 Participants
n=67 Participants
|
17 Participants
n=22 Participants
|
16 Participants
n=21 Participants
|
142 Participants
n=178 Participants
|
|
Prior Treatment for UC
Immunomodulators
|
22 Participants
n=68 Participants
|
28 Participants
n=67 Participants
|
6 Participants
n=22 Participants
|
6 Participants
n=21 Participants
|
62 Participants
n=178 Participants
|
|
Prior Treatment for UC
Biologic/Biologic-Like Use (stratification) Yes
|
35 Participants
n=68 Participants
|
35 Participants
n=67 Participants
|
12 Participants
n=22 Participants
|
12 Participants
n=21 Participants
|
94 Participants
n=178 Participants
|
|
Prior Treatment for UC
Biologic/Biologic-Like Use (stratification) No
|
33 Participants
n=68 Participants
|
32 Participants
n=67 Participants
|
10 Participants
n=22 Participants
|
9 Participants
n=21 Participants
|
84 Participants
n=178 Participants
|
|
Prior Treatment for UC
Biologic/Biologic-Like Use (Prior Medications) Yes
|
32 Participants
n=68 Participants
|
32 Participants
n=67 Participants
|
13 Participants
n=22 Participants
|
10 Participants
n=21 Participants
|
87 Participants
n=178 Participants
|
|
Prior Treatment for UC
Biologic/Biologic-Like Use (Prior Medications) No
|
36 Participants
n=68 Participants
|
35 Participants
n=67 Participants
|
9 Participants
n=22 Participants
|
11 Participants
n=21 Participants
|
91 Participants
n=178 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention
The 3-component Modified Mayo Score (MMS) ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding (RB), and stool frequency (SF) subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=68 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=67 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 Achieving Clinical Remission
|
26.5 Percentage of participants
|
1.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to ~14 weeksPopulation: All randomized participants who received at least one dose of study intervention regardless of assigned cohort
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who experienced at least one AE is reported.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=90 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=88 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experienced an Adverse Event (AE)
|
45.6 Percentage of participants
|
43.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to ~14 weeksPopulation: All randomized participants who received at least one dose of study intervention regardless of assigned cohort
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who discontinued due to an AE is reported.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=90 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=88 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Due to an AE
|
1.1 Percentage of participants
|
3.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to ~14 weeksPopulation: All randomized participants who received at least one dose of study intervention regardless of assigned cohort
Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Serious adverse events are defined as: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Life-threatening consequences; urgent intervention indicated, and death. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants experiencing a serious AE are presented.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=90 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=88 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Had One or More Serious Adverse Events
|
1.1 Percentage of participants
|
8.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Endoscopic improvement is defined by endoscopy subscore of the MMS of ≤ 1 with no friability. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=68 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=67 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 With Endoscopic Improvement
|
36.8 Percentage of participants
|
6.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical response is defined as a reduction from Baseline ≥ 2 points and ≥ 30% in 3-component Modified Mayo Score, accompanied by a reduction ≥ 1 in RB subscore or absolute RB subscore ≤ 1. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=68 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=67 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 Achieving Clinical Response
|
66.2 Percentage of participants
|
22.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=38 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=37 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission
|
31.6 Percentage of participants
|
10.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention
RB, and SF subscores each range from 0 to 3, with higher scores indicating more severe disease. Symptomatic remission is defined as participants with SF subscore = 0 and RB subscore = 0. The percentage of participants who achieved symptomatic remission is presented. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=68 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=67 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 With Symptomatic Remission
|
19.1 Percentage of participants
|
6.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention and had baseline and Week 12 Geboes scores
Histologic improvement is defined as Geboes score ≤ 3.1. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. A higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=65 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=57 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 With Histologic Improvement
|
46.2 Percentage
|
17.5 Percentage
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention and had baseline and Week 12 Geboes scores
Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopy subscore of the MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=65 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=57 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Improvement
|
30.8 Percentage of participants
|
3.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Endoscopic improvement is defined by endoscopy subscore of MMS of ≤ 1 with no friability. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=38 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=37 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Endoscopic Improvement
|
36.8 Percentage of participants
|
18.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical response is defined by reduction from Baseline ≥ 2 points and ≥ 30% in 3-component Modified Mayo Score, accompanied by a reduction ≥ 1 in RB subscore or absolute RB subscore ≤ 1. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=38 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=37 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response
|
55.3 Percentage of Participants
|
32.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention
RB, and SF subscores each range from 0 to 3, with higher scores indicating more severe disease. Symptomatic remission is defined as participants with SF subscore = 0 and RB subscore = 0. The percentage of participants who achieved symptomatic remission is presented. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=38 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=37 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Symptomatic Remission
|
21.1 Percentage of participants
|
10.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention and had baseline and Week 12 data for Geboes Scores
Histologic improvement is defined as Geboes score ≤ 3.1. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. A higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=36 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=30 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic Improvement
|
55.6 Percentage of participants
|
26.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention and had baseline and Week 12 data for Geboes Scores
Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopy subscore of the MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=36 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=30 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Improvement
|
38.9 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention and had baseline and Week 12 data for Geboes Scores
Histologic-endoscopic mucosal improvement is defined as Geboes score ≤ 2B.1 and endoscopy subscore of MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=65 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=57 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Healing
|
30.8 Percentage of participants
|
3.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention and had baseline and Week 12 data for Geboes Scores
Histologic-endoscopic mucosal improvement is defined as Geboes score ≤ 2B.1 and endoscopy subscore of MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=36 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=30 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Healing
|
38.9 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants in Cohort 1 who received at least one dose of study intervention
IBDQ is a self-administered, disease-specific Health-Related Quality of Life (HRQOL) instrument for subjects with IBD. The IBDQ covers 4 dimensions and 32 questions: bowel symptoms, systemic symptoms, emotional function, and social function. Items are scored on a 7-point Likert scale (1 = all of the time and 7 = none of the time), for a total global score in the range 32 to 224 (with higher scores indicating better HRQOL). IBDQ response, as defined by ≥ 16-point increase from Baseline at Week 12. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=68 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=67 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants in Cohort 1 With an Inflammatory Bowel Disease Questionnaire (IBDQ) Response
|
82.4 Percentage of participants
|
49.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who were CDx+ (Cohorts 1 + 2), who received at least one dose of study intervention
IBDQ is a self-administered, disease-specific Health-Related Quality of Life (HRQOL) instrument for subjects with IBD. The IBDQ covers 4 dimensions and 32 questions: bowel symptoms, systemic symptoms, emotional function, and social function. Items are scored on a 7-point Likert scale (1 = all of the time and 7 = none of the time), for a total global score in the range 32 to 224 (with higher scores indicating better HRQOL). IBDQ response, as defined by ≥ 16-point increase from Baseline at Week 12. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 1 Tulisokibart
n=38 Participants
Participants who were CDx+ and CDx- received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
Cohort 1 Placebo
n=37 Participants
Participants who were CDx+ and CDx- received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response
|
76.3 Percentage of participants
|
56.8 Percentage of participants
|
Adverse Events
All Cohorts (Cohort 1 & Cohort 2) Tulisokibart
All Cohorts (Cohort 1 & Cohort 2) Placebo
Serious adverse events
| Measure |
All Cohorts (Cohort 1 & Cohort 2) Tulisokibart
n=90 participants at risk
Participants received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10 regardless of cohort. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
All Cohorts (Cohort 1 & Cohort 2) Placebo
n=88 participants at risk
Participants received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10 regardless of cohort. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/90 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
1.1%
1/88 • Number of events 1 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/90 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
5.7%
5/88 • Number of events 5 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/90 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
1.1%
1/88 • Number of events 1 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
1.1%
1/90 • Number of events 1 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
0.00%
0/88 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
Other adverse events
| Measure |
All Cohorts (Cohort 1 & Cohort 2) Tulisokibart
n=90 participants at risk
Participants received tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10 regardless of cohort. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
All Cohorts (Cohort 1 & Cohort 2) Placebo
n=88 participants at risk
Participants received placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10 regardless of cohort. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
5.6%
5/90 • Number of events 5 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
4.5%
4/88 • Number of events 4 • Death and Adverse Events up to ~14 weeks.
Per protocol death and adverse events are grouped by treatment or placebo irrespective of cohort. Participants in Cohorts 1 and 2 received identical treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp and Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee All information concerning the product subsequently generated from this study (such as patent applications, formulae, manufacturing processes, basic scientific data, or formulation information supplied to the Investigator by the Sponsor and not previously published) is considered confidential by and shall remain the sole property of the Sponsor. The Investigator agrees not to use it for other purposes without the Sponsor's written consent.
- Publication restrictions are in place
Restriction type: OTHER