Trial Outcomes & Findings for Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis (NCT NCT02647866)
NCT ID: NCT02647866
Last Updated: 2024-04-26
Results Overview
To determine the safety and tolerability of KHK4083
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2024-04-26
Participant Flow
Investigative sites in the US, Poland, Czech Republic, Russia, Romania, Serbia, and Hungary screened patients from January 2016 until June 2017, with the first patient enrolled in June 2016.
A total of 109 patients were screened during the recruiting period. Subjects were enrolled into the study only if all inclusion criteria and none of the exclusion criteria were fulfilled.
Participant milestones
| Measure |
KHK4083 Cohort 1
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
Placebo
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
9
|
21
|
17
|
|
Overall Study
Completed Induction Therapy
|
8
|
9
|
8
|
19
|
17
|
|
Overall Study
Completed Induction Therapy Follow-Up
|
5
|
1
|
2
|
0
|
2
|
|
Overall Study
Completed Long-Term Extension Therapy
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed LTE Follow-up
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed Open-Label Extension Therapy
|
0
|
7
|
4
|
17
|
13
|
|
Overall Study
Completed OLE Follow-up
|
0
|
6
|
4
|
14
|
10
|
|
Overall Study
Moved From LTE to OLE Therapy
|
0
|
5
|
0
|
0
|
2
|
|
Overall Study
Discontinued the Treatment
|
4
|
5
|
5
|
5
|
8
|
|
Overall Study
Discontinued the Study
|
5
|
4
|
5
|
6
|
8
|
|
Overall Study
COMPLETED
|
4
|
6
|
4
|
15
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
5
|
6
|
8
|
Reasons for withdrawal
| Measure |
KHK4083 Cohort 1
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
Placebo
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
2
|
1
|
|
Overall Study
Disease Worsening
|
3
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
4
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject moved to different country
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
KHK4083 Cohort 1
n=9 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=10 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=9 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=21 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
Placebo
n=17 Participants
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Age, Continuous
|
47.3 years
n=5 Participants
|
46.1 years
n=7 Participants
|
41.2 years
n=5 Participants
|
41.1 years
n=4 Participants
|
33.8 years
n=21 Participants
|
40.8 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
|
Race (NIH/OMB)
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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
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=8 Participants
|
|
Race (NIH/OMB)
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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo).
To determine the safety and tolerability of KHK4083
Outcome measures
| Measure |
KHK4083 Cohort 1
n=9 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=10 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=9 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=21 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=49 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
n=17 Participants
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-related Adverse Events
With Any TEAE
|
5 Participants
|
7 Participants
|
7 Participants
|
14 Participants
|
33 Participants
|
13 Participants
|
|
Number of Subjects With Treatment-related Adverse Events
With Any Drug-related TEAE
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
|
Number of Subjects With Treatment-related Adverse Events
With Any TEAE with an Outcome of Death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo).
To determine the safety and tolerability of KHK4083
Outcome measures
| Measure |
KHK4083 Cohort 1
n=9 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=10 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=9 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=21 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=49 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
n=17 Participants
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-related Serious Adverse Events
With Any Serious TEAE
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Treatment-related Serious Adverse Events
With Any Drug-related Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment-related Serious Adverse Events
Who Died
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=22 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=37 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=15 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Show Improvement in the Mucosa at Week 12
mMES Improvement
|
2 Participants
|
4 Participants
|
9 Participants
|
15 Participants
|
5 Participants
|
—
|
|
Number of Subjects Who Show Improvement in the Mucosa at Week 12
Modified Baron Endoscopic Score Improvement
|
3 Participants
|
5 Participants
|
8 Participants
|
16 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: 52 weeksMeasured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=21 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=36 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=14 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Proportion of Subjects Who Show Improvement in the Mucosa at Week 52
|
1 Participants
|
3 Participants
|
9 Participants
|
13 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All subjects who received at least one dose of KHK4083, including 14 subjects initially randomized to placebo and who then continued into Open-Label Extension therapy, where they received the maximum tolerated dose of KHK4083.
The immunogenicity was assessed by determination of the development of anti-drug antibodies (ADA) against KHK4083.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=9 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=10 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=9 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=21 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=14 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)
Subjects with Pre-Existing ADA at Baseline
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)
Subjects with Production of Treatment-Induced ADA
|
3 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1 at Week 12.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=22 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=37 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=15 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve Mucosal Healing at Week 12
|
1 Participants
|
3 Participants
|
8 Participants
|
12 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksThe endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=21 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=36 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=14 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve Mucosal Healing at Week 52
|
1 Participants
|
3 Participants
|
7 Participants
|
11 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement will be based on a reduction in the total Mayo Clinic score.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=22 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=37 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=15 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve Clinical Improvement at Week 12
|
2 Participants
|
4 Participants
|
9 Participants
|
15 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The overall number of participants is the number in the full analysis set. The number of patients analyzed is the number of patients who had values at the noted visits. There were no subjects in the 10.0 mg/kg KHK4083 group in the LTE Therapy Period. There were no subjects in the 1.0 mg/kg KHK4083 group in the OLE Therapy Period.
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement was based on a reduction (mean change from Baseline \[Week 0\] to Week 52) in the total Mayo Clinic score.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=22 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=37 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=15 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Total Mayo Scale Score at Week 52
LTE Period - Baseline Score
|
8.0 score on a scale
Standard Deviation 0.0
|
7.8 score on a scale
Standard Deviation 0.8
|
—
|
7.9 score on a scale
Standard Deviation 0.6
|
7.5 score on a scale
Standard Deviation 2.1
|
—
|
|
Change From Baseline in Total Mayo Scale Score at Week 52
LTE Period - Week 52 Score
|
2.5 score on a scale
Standard Deviation 2.1
|
—
|
—
|
2.5 score on a scale
Standard Deviation 2.1
|
—
|
—
|
|
Change From Baseline in Total Mayo Scale Score at Week 52
LTE Period - Week 52 Change from Baseline
|
-5.5 score on a scale
Standard Deviation 2.1
|
—
|
—
|
-5.5 score on a scale
Standard Deviation 2.1
|
—
|
—
|
|
Change From Baseline in Total Mayo Scale Score at Week 52
OLE Period - Baseline Score
|
—
|
7.6 score on a scale
Standard Deviation 1.1
|
7.8 score on a scale
Standard Deviation 1.5
|
7.8 score on a scale
Standard Deviation 1.4
|
7.6 score on a scale
Standard Deviation 0.9
|
—
|
|
Change From Baseline in Total Mayo Scale Score at Week 52
OLE Period - Week 52 Score
|
—
|
3.7 score on a scale
Standard Deviation 3.1
|
3.6 score on a scale
Standard Deviation 2.4
|
3.6 score on a scale
Standard Deviation 2.5
|
4.3 score on a scale
Standard Deviation 3.4
|
—
|
|
Change From Baseline in Total Mayo Scale Score at Week 52
OLE Period - Week 52 Change from Baseline
|
—
|
-4.0 score on a scale
Standard Deviation 2.4
|
-4.4 score on a scale
Standard Deviation 2.7
|
-4.3 score on a scale
Standard Deviation 2.5
|
-3.5 score on a scale
Standard Deviation 2.8
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response is a reduction in the total Mayo Clinic score of at least 3 points.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=22 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=37 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=15 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve a Clinical Response at Week 12
|
3 Participants
|
8 Participants
|
11 Participants
|
22 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksThe Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response indicates the change from Baseline in the Total Mayo Clinic score \<= -3 and the percentage change from Baseline in the Total Mayo Clinic score \<= -30% to Week 12, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of \<= 1.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=21 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=36 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=14 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve a Clinical Response at Week 52
|
2 Participants
|
4 Participants
|
14 Participants
|
20 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksThe Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores \> 1.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=22 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=37 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=15 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve Clinical Remission at Week 12
|
1 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksThe Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores \> 1.
Outcome measures
| Measure |
KHK4083 Cohort 1
n=7 Participants
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 2
n=8 Participants
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 3
n=21 Participants
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Cohort 4
n=36 Participants
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
|
KHK4083 Combined
n=14 Participants
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
|
Placebo
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Achieve Clinical Remission at Week 52
|
1 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
—
|
Adverse Events
KHK4083 Cohort 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
KHK4083 Cohort 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
KHK4083 Cohort 3
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
KHK4083 Cohort 4
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
KHK4083 Combined
Serious events: 6 serious events
Other events: 32 other events
Deaths: 1 deaths
Placebo
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KHK4083 Cohort 1
n=9 participants at risk
Subjects who qualify will receive 1.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Cohort 2
n=10 participants at risk
Subjects who qualify will receive 3.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Cohort 3
n=9 participants at risk
Subjects who qualify will receive 10.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Cohort 4
n=21 participants at risk
Subjects who qualify will receive maximum tolerated dose (10.0 mg/kg) IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Combined
n=49 participants at risk
The total number of participants analyzed who were randomized to KHK4083 during Treatment parts A \& B.
|
Placebo
n=17 participants at risk
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
11.1%
1/9 • Number of events 2 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
6.1%
3/49 • Number of events 4 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 2 • 52 Weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 2 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 2 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Investigations
Blood albumin decreased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
Other adverse events
| Measure |
KHK4083 Cohort 1
n=9 participants at risk
Subjects who qualify will receive 1.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Cohort 2
n=10 participants at risk
Subjects who qualify will receive 3.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Cohort 3
n=9 participants at risk
Subjects who qualify will receive 10.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Cohort 4
n=21 participants at risk
Subjects who qualify will receive maximum tolerated dose (10.0 mg/kg) IV infusion treatments of KHK4083 from Baseline to Week 48.
|
KHK4083 Combined
n=49 participants at risk
The total number of participants analyzed who were randomized to KHK4083 during Treatment parts A \& B.
|
Placebo
n=17 participants at risk
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 2 • 52 Weeks
|
20.0%
2/10 • Number of events 2 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
14.3%
3/21 • Number of events 3 • 52 Weeks
|
14.3%
7/49 • Number of events 7 • 52 Weeks
|
17.6%
3/17 • Number of events 4 • 52 Weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
4.1%
2/49 • Number of events 2 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Congenital, familial and genetic disorders
Renal aplasia
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • 52 Weeks
|
30.0%
3/10 • Number of events 3 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
6.1%
3/49 • Number of events 3 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
9.5%
2/21 • Number of events 2 • 52 Weeks
|
10.2%
5/49 • Number of events 5 • 52 Weeks
|
29.4%
5/17 • Number of events 5 • 52 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 2 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 2 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
4.1%
2/49 • Number of events 2 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
General disorders
Asthenia
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
6.1%
3/49 • Number of events 3 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
General disorders
Pyrexia
|
33.3%
3/9 • Number of events 3 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
12.2%
6/49 • Number of events 6 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
4.1%
2/49 • Number of events 2 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Scar
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Investigations
Amylase increased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
11.8%
2/17 • Number of events 2 • 52 Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
11.8%
2/17 • Number of events 2 • 52 Weeks
|
|
Investigations
Blood creatine phosphokinase abnormal
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
4.8%
1/21 • Number of events 2 • 52 Weeks
|
4.1%
2/49 • Number of events 3 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Investigations
Blood folate decreased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Investigations
C-reactive protein increased
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Investigations
Lipase increased
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • Number of events 2 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
4.8%
1/21 • Number of events 1 • 52 Weeks
|
6.1%
3/49 • Number of events 3 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
0.00%
0/49 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
4.1%
2/49 • Number of events 2 • 52 Weeks
|
5.9%
1/17 • Number of events 1 • 52 Weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyageal pain
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9 • 52 Weeks
|
10.0%
1/10 • Number of events 1 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
1/9 • Number of events 1 • 52 Weeks
|
0.00%
0/10 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
0.00%
0/21 • 52 Weeks
|
2.0%
1/49 • Number of events 1 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
Additional Information
Kyowa Kirin Pharmaceutical Development
Kyowa Kirin Pharmaceutical Development
Phone: 609-919-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60