Trial Outcomes & Findings for Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis (NCT NCT04596293)
NCT ID: NCT04596293
Last Updated: 2023-09-07
Results Overview
Clinical Response was defined as a Total Mayo Score, as measured by a reduction of ≥ 3 points and ≥ 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore ≤ 1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Day 57
Results posted on
2023-09-07
Participant Flow
Participants with moderate to severe Ulcerative Colitis (UC) were to be randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups. A total of 38 participants were enrolled and evaluated as Safety Population. Out of 38 participants, and 33 were considered Intent-to-Treatment Population and evaluated for study outcomes.
Participant milestones
| Measure |
Placebo
* Induction Phase: Placebo for 8 weeks
* Extension Phase: After 8 weeks,
* Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks
* Participants who did not achieve clinical remission in the induction phase will receive BBT-401 800mg for 8 weeks
|
BBT-401-1S (800mg)
* Induction Phase: BBT-401 800mg for 8 weeks
* Extension Phase: After 8 weeks,
* Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks
* Participants who did not achieve clinical remission in the induction phase will receive BBT-401 1600mg for 8 weeks
|
BBT-401-1S (1,600mg)
* Induction Phase: BBT-401 1600mg for 8 weeks
* Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks
|
|---|---|---|---|
|
Induction Phase Week 0-8
STARTED
|
11
|
11
|
11
|
|
Induction Phase Week 0-8
Safety Population
|
13
|
12
|
13
|
|
Induction Phase Week 0-8
COMPLETED
|
11
|
11
|
10
|
|
Induction Phase Week 0-8
NOT COMPLETED
|
0
|
0
|
1
|
|
Extension Phase Week 8-16
STARTED
|
11
|
11
|
9
|
|
Extension Phase Week 8-16
Safety Population
|
6
|
8
|
17
|
|
Extension Phase Week 8-16
COMPLETED
|
11
|
10
|
8
|
|
Extension Phase Week 8-16
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Placebo for 8 weeks as induction phase + Placebo or BBT-401-1S 800mg for 8 weeks as extension phase
|
BBT-401-1S (800mg)
n=11 Participants
BBT-401-1S 800mg for 8 weeks as induction phase + BBT-401-1S 800mg or BBT-401-1S 1600mg for 8 weeks as extension phase
|
BBT-401-1S (1,600mg)
n=11 Participants
BBT-401-1S 1600mg for 8 weeks as induction phase + BBT-401-1S 1600mg for 8 weeks as extension phase
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
South Korea
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 57Population: The intent-to-treat (ITT) population included all subjects who receive at least 1 dose of study drug, and who have a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded. Subjects are categorized in the treatment group to which they are randomized.
Clinical Response was defined as a Total Mayo Score, as measured by a reduction of ≥ 3 points and ≥ 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore ≤ 1
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo for 8 weeks as induction phase + Placebo or BBT-401-1S 800mg for 8 weeks as extension phase
|
BBT-401-1S (800mg)
n=11 Participants
BBT-401-1S 800mg for 8 weeks as induction phase + BBT-401-1S 800mg or BBT-401-1S 1600mg for 8 weeks as extension phase
|
BBT-401-1S (1,600mg)
n=11 Participants
BBT-401-1S 1600mg for 8 weeks as induction phase + BBT-401-1S 1600mg for 8 weeks as extension phase
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
SECONDARY outcome
Timeframe: Day 57Clinical Remission was defined as a Total Mayo score, as measured by a total Mayo score of ≤ 2 points, with no individual subscore exceeding 1 point. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score is consisted of 4 subscores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment), each graded from 0 to 3 with higher scores indicating more severe disease
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo for 8 weeks as induction phase + Placebo or BBT-401-1S 800mg for 8 weeks as extension phase
|
BBT-401-1S (800mg)
n=11 Participants
BBT-401-1S 800mg for 8 weeks as induction phase + BBT-401-1S 800mg or BBT-401-1S 1600mg for 8 weeks as extension phase
|
BBT-401-1S (1,600mg)
n=11 Participants
BBT-401-1S 1600mg for 8 weeks as induction phase + BBT-401-1S 1600mg for 8 weeks as extension phase
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57
|
36.4 Percentage of Participants
Interval 10.9 to 69.2
|
18.2 Percentage of Participants
Interval 2.3 to 51.8
|
9.1 Percentage of Participants
Interval 0.2 to 41.3
|
SECONDARY outcome
Timeframe: Day 57Endoscopic Remission was defined as a Mayo endoscopic subscore of 0 or 1. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score is consisted of 4 subscores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment), each graded from 0 to 3 with higher scores indicating more severe disease
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo for 8 weeks as induction phase + Placebo or BBT-401-1S 800mg for 8 weeks as extension phase
|
BBT-401-1S (800mg)
n=11 Participants
BBT-401-1S 800mg for 8 weeks as induction phase + BBT-401-1S 800mg or BBT-401-1S 1600mg for 8 weeks as extension phase
|
BBT-401-1S (1,600mg)
n=11 Participants
BBT-401-1S 1600mg for 8 weeks as induction phase + BBT-401-1S 1600mg for 8 weeks as extension phase
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an Endoscopic Remission at Day 57
|
45.5 Percentage of Participants
Interval 16.7 to 76.6
|
36.4 Percentage of Participants
Interval 10.9 to 69.2
|
27.3 Percentage of Participants
Interval 6.0 to 61.0
|
SECONDARY outcome
Timeframe: Baseline, Day 57Change from Baseline to Day 57 in Total Mayo Score. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score, ranged from 0 to 12, are sum of 4 subscores. Subscores are stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment, each graded from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo for 8 weeks as induction phase + Placebo or BBT-401-1S 800mg for 8 weeks as extension phase
|
BBT-401-1S (800mg)
n=11 Participants
BBT-401-1S 800mg for 8 weeks as induction phase + BBT-401-1S 800mg or BBT-401-1S 1600mg for 8 weeks as extension phase
|
BBT-401-1S (1,600mg)
n=11 Participants
BBT-401-1S 1600mg for 8 weeks as induction phase + BBT-401-1S 1600mg for 8 weeks as extension phase
|
|---|---|---|---|
|
Change From Baseline to Day 57 in Total Mayo Score
Baseline
|
8.8 Scores on a scale
Standard Deviation 1.08
|
9.1 Scores on a scale
Standard Deviation 1.70
|
8.4 Scores on a scale
Standard Deviation 1.75
|
|
Change From Baseline to Day 57 in Total Mayo Score
Day 57
|
4.5 Scores on a scale
Standard Deviation 3.17
|
6.2 Scores on a scale
Standard Deviation 3.37
|
5.6 Scores on a scale
Standard Deviation 2.55
|
|
Change From Baseline to Day 57 in Total Mayo Score
Change from Baseline
|
-4.3 Scores on a scale
Standard Deviation 2.72
|
-2.9 Scores on a scale
Standard Deviation 2.47
|
-2.6 Scores on a scale
Standard Deviation 1.71
|
Adverse Events
Placebo/Induction Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BBT-401-1S 800mg/Induction Phase
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BBT-401-1S 1600mg/Induction Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo/Extension Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BBT-401-1S 800mg/ Extension Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BBT-401-1S 1600mg/ Extension Phase
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Induction Phase
n=13 participants at risk
Participants who received placebo in induction phase for 8 weeks
|
BBT-401-1S 800mg/Induction Phase
n=12 participants at risk
Participants who received BBT-401-1S 800mg in induction phase for 8 weeks
|
BBT-401-1S 1600mg/Induction Phase
n=13 participants at risk
Participants who received BBT-401-1S 1600mg in induction phase for 8 weeks
|
Placebo/Extension Phase
n=6 participants at risk
Participants who received placebo in extension phase for 8 weeks
|
BBT-401-1S 800mg/ Extension Phase
n=8 participants at risk
Participants who received BBT-401-1S 800mg in extension phase for 8 weeks
|
BBT-401-1S 1600mg/ Extension Phase
n=17 participants at risk
Participants who received BBT-401-1S 1600mg in extension phase for 8 weeks
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Bartholin's cyst removal
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
8.3%
1/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
Other adverse events
| Measure |
Placebo/Induction Phase
n=13 participants at risk
Participants who received placebo in induction phase for 8 weeks
|
BBT-401-1S 800mg/Induction Phase
n=12 participants at risk
Participants who received BBT-401-1S 800mg in induction phase for 8 weeks
|
BBT-401-1S 1600mg/Induction Phase
n=13 participants at risk
Participants who received BBT-401-1S 1600mg in induction phase for 8 weeks
|
Placebo/Extension Phase
n=6 participants at risk
Participants who received placebo in extension phase for 8 weeks
|
BBT-401-1S 800mg/ Extension Phase
n=8 participants at risk
Participants who received BBT-401-1S 800mg in extension phase for 8 weeks
|
BBT-401-1S 1600mg/ Extension Phase
n=17 participants at risk
Participants who received BBT-401-1S 1600mg in extension phase for 8 weeks
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
8.3%
1/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
7.7%
1/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
8.3%
1/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
8.3%
1/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Investigations
Blood glucose increased
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
16.7%
1/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
8.3%
1/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Investigations
Coagulation factor decreased
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
5.9%
1/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
5.9%
1/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
5.9%
1/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
5.9%
1/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
5.9%
1/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
5.9%
1/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/12 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/13 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/6 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
12.5%
1/8 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
0.00%
0/17 • From ICF consent up to 16 weeks for those who had completed the study or discontinued early
The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place