Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC) (NCT NCT03558152)
NCT ID: NCT03558152
Last Updated: 2023-04-14
Results Overview
Clinical remission is defined as modified Mayo Clinic Score (mMCS) \<= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore \<=1 and Centrally read endoscopic score \<= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-04-14
Participant Flow
Patients were assigned in a 1:1:1:1:1:1:2:1 ratio to one of eight treatment arms. Following completion of the screening period and after all patient eligibility requirements were confirmed, patients were assigned a patient number and randomly assigned to a treatment arm through an interactive voice or Web-based response system (IxRS).
Participant milestones
| Measure |
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm: 2A: UTTR1147A 60 + UTTR1147A
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
Arm: 2B: UTTR1147A 60 + Placebo
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
21
|
23
|
22
|
21
|
43
|
22
|
|
Overall Study
COMPLETED
|
7
|
6
|
8
|
8
|
3
|
7
|
21
|
6
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
13
|
15
|
19
|
14
|
22
|
16
|
Reasons for withdrawal
| Measure |
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm: 2A: UTTR1147A 60 + UTTR1147A
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
Arm: 2B: UTTR1147A 60 + Placebo
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
2
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Rolled over in GA40209 due to worsening of disease
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Miscalculation in mmcs
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Mistake in calculation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Mistake in evaluation of disease status
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
2
|
1
|
1
|
1
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
11
|
11
|
10
|
11
|
14
|
12
|
14
|
13
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
1
|
1
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Baseline characteristics by cohort
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
39.4 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
39.5 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
41.9 Years
STANDARD_DEVIATION 14.0 • n=21 Participants
|
40.8 Years
STANDARD_DEVIATION 13.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
135 Participants
n=10 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=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
195 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
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=10 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=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
194 Participants
n=10 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=10 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=10 Participants
|
PRIMARY outcome
Timeframe: 8 weeksClinical remission is defined as modified Mayo Clinic Score (mMCS) \<= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore \<=1 and Centrally read endoscopic score \<= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission at Week 8
Yes
|
5 Participants
|
4 Participants
|
5 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Percentage of Participants With Clinical Remission at Week 8
No
|
38 Participants
|
40 Participants
|
38 Participants
|
32 Participants
|
20 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 8 and 30Sustained remission is defined as clinical remission at both Week 8 and Week 30, where clinical remission is defined as modified Mayo Clinic Score (mMCS) \<= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore \<=1 and Centrally read endoscopic score \<= 1. Patients were classified as Non-Remitters at Week 8 or at Week 30 if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment
Outcome measures
| Measure |
Arm 1
n=22 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=21 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=21 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=23 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=21 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Remission
|
4.55 Percentage of Participants
Interval 0.48 to 16.56
|
0.00 Percentage of Participants
Interval 0.0 to 10.38
|
0.00 Percentage of Participants
Interval 0.0 to 10.38
|
8.70 Percentage of Participants
Interval 2.34 to 21.52
|
4.55 Percentage of Participants
Interval 0.48 to 16.56
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
20.93 Percentage of Participants
Interval 13.04 to 31.02
|
9.09 Percentage of Participants
Interval 2.44 to 22.42
|
SECONDARY outcome
Timeframe: Days 1 - 29, Visit: Day 57Population: Due to low enrollment in Part B of the study, the PK data from pooled Arms 1-3 (1A + 1B; 2A + 2B; 3A + 3B) are summarized based on data up through Week 8 which is the primary efficacy assessment for Part A (Induction phase). A total of 130 patients who received at least one dose of efmarodocokin alfa and had measurable PK concentrations are included in the analysis.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of UTTR1147A
Visit: Days 1 - 29
|
449 ng/mL
Standard Deviation 658
|
590 ng/mL
Standard Deviation 265
|
837 ng/mL
Standard Deviation 560
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of UTTR1147A
Visit: Day 57
|
426 ng/mL
Standard Deviation 344
|
693 ng/mL
Standard Deviation 348
|
1340 ng/mL
Standard Deviation 883
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 - 29, Visit: Day 57Population: Due to low enrollment in Part B of the study, the PK data from pooled Arms 1-3 (1A + 1B; 2A + 2B; 3A + 3B) are summarized based on data up through Week 8 which is the primary efficacy assessment for Part A (Induction phase). A total of 130 patients who received at least one dose of efmarodocokin alfa and had measurable PK concentrations are included in the analysis.
Outcome measures
| Measure |
Arm 1
n=39 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=40 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=42 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of UTTR1147A
Days 1 - 29
|
12.6 ng/mL
Standard Deviation 9.55
|
28.3 ng/mL
Standard Deviation 17.1
|
40.6 ng/mL
Standard Deviation 27.7
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Serum Concentration (Cmin) of UTTR1147A
Visit: Day 57
|
15.8 ng/mL
Standard Deviation 11.7
|
37.2 ng/mL
Standard Deviation 35.2
|
44.5 ng/mL
Standard Deviation 28.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A \>= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A \>= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment. NOTE: An Outcome Measure Description has not been entered.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Response at Week 8
|
30.23 Percentage of Participants
Interval 20.99 to 40.95
|
36.36 Percentage of Participants
Interval 26.6 to 47.12
|
20.93 Percentage of Participants
Interval 13.04 to 31.02
|
53.49 Percentage of Participants
Interval 42.64 to 64.08
|
36.36 Percentage of Participants
Interval 22.48 to 52.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 30Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A \>= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A \>= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Outcome measures
| Measure |
Arm 1
n=22 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=21 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=21 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=23 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=21 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Response at Week 30
|
9.09 Percentage of Participants
Interval 2.44 to 22.42
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
13.04 Percentage of Participants
Interval 4.89 to 26.78
|
0.00 Percentage of Participants
Interval 0.0 to 9.94
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
13.95 Percentage of Participants
Interval 7.5 to 23.21
|
0.00 Percentage of Participants
Interval 0.0 to 9.94
|
SECONDARY outcome
Timeframe: At Week 8Endoscopic healing is defined as a Mayo endoscopic subscore \<= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Healing at Week 8
|
13.95 Percentage of Participants
Interval 7.5 to 23.21
|
13.64 Percentage of Participants
Interval 7.32 to 22.71
|
11.63 Percentage of Participants
Interval 5.77 to 20.51
|
32.56 Percentage of Participants
Interval 23.05 to 43.36
|
13.64 Percentage of Participants
Interval 5.12 to 27.89
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 30Endoscopic healing is defined as a Mayo endoscopic subscore \<= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Outcome measures
| Measure |
Arm 1
n=22 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=21 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=21 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=23 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=21 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Healing at Week 30
|
13.64 Percentage of Participants
Interval 5.12 to 27.89
|
9.52 Percentage of Participants
Interval 2.56 to 23.4
|
14.29 Percentage of Participants
Interval 5.37 to 29.1
|
13.04 Percentage of Participants
Interval 4.89 to 26.78
|
4.55 Percentage of Participants
Interval 0.48 to 16.56
|
19.05 Percentage of Participants
Interval 8.58 to 34.52
|
30.23 Percentage of Participants
Interval 20.99 to 40.95
|
9.09 Percentage of Participants
Interval 2.44 to 22.42
|
SECONDARY outcome
Timeframe: At Week 8Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Remission at Week 8
|
4.65 Percentage of Participants
Interval 1.24 to 11.91
|
0.00 Percentage of Participants
Interval 0.0 to 5.1
|
4.65 Percentage of Participants
Interval 1.24 to 11.91
|
11.63 Percentage of Participants
Interval 5.77 to 20.51
|
0.00 Percentage of Participants
Interval 0.0 to 9.94
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 30Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Outcome measures
| Measure |
Arm 1
n=22 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=21 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=21 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=23 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=21 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Remission at Week 30
|
9.09 Percentage of Participants
Interval 2.44 to 22.42
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
13.04 Percentage of Participants
Interval 4.89 to 26.78
|
0.00 Percentage of Participants
Interval 0.0 to 9.94
|
4.76 Percentage of Participants
Interval 0.5 to 17.29
|
13.95 Percentage of Participants
Interval 7.5 to 23.21
|
0.00 Percentage of Participants
Interval 0.0 to 9.94
|
SECONDARY outcome
Timeframe: At Week 8The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
|
-4.14 Points on scale
Standard Deviation 5.06
|
-6.39 Points on scale
Standard Deviation 4.68
|
-3.56 Points on scale
Standard Deviation 6.11
|
-6.23 Points on scale
Standard Deviation 5.35
|
-4.95 Points on scale
Standard Deviation 5.70
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 30Population: Number of analyzed participants reflects number of participants who submitted the EC-PRO questionnaire at Week 30.
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Outcome measures
| Measure |
Arm 1
n=5 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=6 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=7 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=7 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=1 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=5 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=20 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=5 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
|
-5.66 Points on scale
Standard Deviation 7.92
|
-3.62 Points on scale
Standard Deviation 4.11
|
-9.63 Points on scale
Standard Deviation 5.15
|
-6.63 Points on scale
Standard Deviation 3.60
|
-12.0 Points on scale
Standard Deviation NA
No SD calculated as only 1 participant was analyzed.
|
-5.44 Points on scale
Standard Deviation 9.47
|
-8.32 Points on scale
Standard Deviation 3.69
|
-6.86 Points on scale
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: At Week 8The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
|
-0.96 Points on scale
Standard Deviation 1.81
|
-1.83 Points on scale
Standard Deviation 1.76
|
-1.82 Points on scale
Standard Deviation 2.44
|
-1.69 Points on scale
Standard Deviation 2.25
|
-1.15 Points on scale
Standard Deviation 2.06
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 30Population: Number of analyzed participants reflects number of participants who submitted the EC-PRO questionnaire at Week 30.
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Outcome measures
| Measure |
Arm 1
n=5 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=6 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=6 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=6 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=4 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=17 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=5 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
|
-1.76 Points on scale
Standard Deviation 3.21
|
-0.64 Points on scale
Standard Deviation 0.89
|
-1.98 Points on scale
Standard Deviation 2.06
|
-1.05 Points on scale
Standard Deviation 0.53
|
—
|
-4.05 Points on scale
Standard Deviation 1.96
|
-1.82 Points on scale
Standard Deviation 1.90
|
-1.50 Points on scale
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: At Week 8The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Outcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
|
31.85 Points on scale
Standard Deviation 39.64
|
31.95 Points on scale
Standard Deviation 30.66
|
25.16 Points on scale
Standard Deviation 40.00
|
44.85 Points on scale
Standard Deviation 30.75
|
27.05 Points on scale
Standard Deviation 41.35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 30The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Outcome measures
| Measure |
Arm 1
n=22 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=21 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=21 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=23 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=21 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30
|
45.13 Points on scale
Standard Deviation 28.62
|
35.50 Points on scale
Standard Deviation 27.45
|
41.00 Points on scale
Standard Deviation 23.28
|
41.38 Points on scale
Standard Deviation 32.00
|
72.33 Points on scale
Standard Deviation 19.35
|
55.43 Points on scale
Standard Deviation 56.89
|
61.95 Points on scale
Standard Deviation 34.75
|
53.00 Points on scale
Standard Deviation 45.84
|
SECONDARY outcome
Timeframe: Up to 30 weeksOutcome measures
| Measure |
Arm 1
n=43 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=44 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=43 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=43 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
Non-Serious Adverse Events
|
12 Participants
|
11 Participants
|
15 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events
Serious Adverse Events
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30Population: Participants in placebo groups were not analyzed for post-baseline Anti-Drug Antibodies (ADA)
Outcome measures
| Measure |
Arm 1
n=22 Participants
Participants received UTTR1147A at a dose of 30 ug/kg
|
Arm 2
n=21 Participants
Participants received UTTR1147A at a dose of 60 ug/kg
|
Arm 3
n=21 Participants
Participants received UTTR1147A at a dose of 90 ug/kg
|
Arm 4: Vedolizumab
n=23 Participants
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
n=22 Participants
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
n=21 Participants
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
|
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Arm 1: UTTR1147A 30 ug/kg Induction
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2: UTTR1147A 60 ug/kg Induction
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 3: UTTR1147A 90 ug/kg Induction
Serious events: 5 serious events
Other events: 15 other events
Deaths: 1 deaths
Arm 4: VEDOLIZUMAB 300 mg Induction
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 5: PLACEBO Induction
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1A: UTTR1147A 30 + UTTR1147A 60Maintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1B: UTTR1147A 30 + PLACEBOMaintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2A: UTTR1147A 60 + UTTR1147A 60Maintenance
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
2B: UTTR1147A 60 + PLACEBOMaintenance
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3A: UTTR1147A 90 + UTTR1147A 60Maintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3B: UTTR1147A 90 + PLACEBOMaintenance
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARM4: VEDOLIZUMAB 300 + VEDOLIZUMAB 300Maintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ARM5: PLACEBO + PLACEBOMaintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: UTTR1147A 30 ug/kg Induction
n=43 participants at risk
Combined arms: 1A: UTTR1147A 30 + UTTR1147A and 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
|
Arm 2: UTTR1147A 60 ug/kg Induction
n=44 participants at risk
Combined arms: 2A: UTTR1147A 60 + UTTR1147A and 2B: UTTR1147A 60 + Placebo
|
Arm 3: UTTR1147A 90 ug/kg Induction
n=43 participants at risk
Combined arms: 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) and 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
|
Arm 4: VEDOLIZUMAB 300 mg Induction
n=43 participants at risk
Parts A and B: Vedolizumab and UTTR1147A Placebo.
|
Arm 5: PLACEBO Induction
n=22 participants at risk
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
|
1A: UTTR1147A 30 + UTTR1147A 60Maintenance
n=10 participants at risk
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
1B: UTTR1147A 30 + PLACEBOMaintenance
n=7 participants at risk
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
2A: UTTR1147A 60 + UTTR1147A 60Maintenance
n=10 participants at risk
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
2B: UTTR1147A 60 + PLACEBOMaintenance
n=9 participants at risk
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
3A: UTTR1147A 90 + UTTR1147A 60Maintenance
n=6 participants at risk
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
3B: UTTR1147A 90 + PLACEBOMaintenance
n=8 participants at risk
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
ARM4: VEDOLIZUMAB 300 + VEDOLIZUMAB 300Maintenance
n=22 participants at risk
Parts A and B: Vedolizumab and UTTR1147A Placebo.
|
ARM5: PLACEBO + PLACEBOMaintenance
n=7 participants at risk
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 1 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.3%
1/43 • Number of events 1 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 1 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
9.3%
4/43 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 1 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 1 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
Other adverse events
| Measure |
Arm 1: UTTR1147A 30 ug/kg Induction
n=43 participants at risk
Combined arms: 1A: UTTR1147A 30 + UTTR1147A and 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
|
Arm 2: UTTR1147A 60 ug/kg Induction
n=44 participants at risk
Combined arms: 2A: UTTR1147A 60 + UTTR1147A and 2B: UTTR1147A 60 + Placebo
|
Arm 3: UTTR1147A 90 ug/kg Induction
n=43 participants at risk
Combined arms: 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) and 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
|
Arm 4: VEDOLIZUMAB 300 mg Induction
n=43 participants at risk
Parts A and B: Vedolizumab and UTTR1147A Placebo.
|
Arm 5: PLACEBO Induction
n=22 participants at risk
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
|
1A: UTTR1147A 30 + UTTR1147A 60Maintenance
n=10 participants at risk
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
1B: UTTR1147A 30 + PLACEBOMaintenance
n=7 participants at risk
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
2A: UTTR1147A 60 + UTTR1147A 60Maintenance
n=10 participants at risk
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
2B: UTTR1147A 60 + PLACEBOMaintenance
n=9 participants at risk
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
3A: UTTR1147A 90 + UTTR1147A 60Maintenance
n=6 participants at risk
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
|
3B: UTTR1147A 90 + PLACEBOMaintenance
n=8 participants at risk
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
|
ARM4: VEDOLIZUMAB 300 + VEDOLIZUMAB 300Maintenance
n=22 participants at risk
Parts A and B: Vedolizumab and UTTR1147A Placebo.
|
ARM5: PLACEBO + PLACEBOMaintenance
n=7 participants at risk
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.7%
2/43 • Number of events 6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
16.7%
1/6 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
12.5%
1/8 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43 • Number of events 6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
11.4%
5/44 • Number of events 14 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
20.9%
9/43 • Number of events 28 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
20.0%
2/10 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
3/43 • Number of events 6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.7%
2/43 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
16.7%
1/6 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
16.7%
1/6 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
COVID-19
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
11.1%
1/9 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
12.5%
1/8 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
12.5%
1/8 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
2/43 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
6.8%
3/44 • Number of events 6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
4.5%
1/22 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
11.1%
1/9 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
16.7%
1/6 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
14.3%
1/7 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
14.3%
1/7 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
2/43 • Number of events 6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
11.1%
1/9 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
11.1%
1/9 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Investigations
Blood glucose increased
|
4.7%
2/43 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
14.3%
1/7 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
14.3%
1/7 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
10.0%
1/10 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
9.1%
2/22 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/6 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
25.0%
2/8 • Number of events 4 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/44 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
2.3%
1/43 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
16.7%
1/6 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
|
Vascular disorders
Hypotension
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/44 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/43 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/10 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/9 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
16.7%
1/6 • Number of events 2 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/8 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/22 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
0.00%
0/7 • Baseline up to 30 weeks
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER