Trial Outcomes & Findings for A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) (NCT NCT04677179)
NCT ID: NCT04677179
Last Updated: 2023-09-05
Results Overview
Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Week 12
Results posted on
2023-09-05
Participant Flow
The study consisted of: * a 12-week induction treatment period: participants randomly received either high dose LY3471851 or low dose LY3471851 or placebo. * a 40-week maintenance/extension treatment period (final dose at week 50 and study assessments at week 52) * (i) Week 12 responders enter the maintenance period where they continued to receive the same treatment to which they were randomly assigned. (Continued..)
* (ii) Week 12 non-responders enter the extension period where they received high dose LY3471851. At week 26, those who responded to treatment continued with the same treatment, while non-responders discontinued and entered follow-up. * a 6-week post-treatment follow-up period: Following treatment completion or discontinuation, participants entered the follow-up period and were observed for safety. No treatments were administered.
Participant milestones
| Measure |
High Dose LY3471851 (Induction Treatment Period)
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Placebo (Induction Treatment Period)
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Maintenance Treatment Period)
Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Low Dose LY3471851 (Maintenance Treatment Period)
Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Placebo (Maintenance Treatment Period)
Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.
|
High Dose LY3471851 (Extension Treatment Period)
Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
|
High Dose LY3471851 (Post-Treatment Follow-up Period)
Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Low Dose LY3471851 (Post-Treatment Follow-up Period)
Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Placebo (Post-Treatment Follow-up Period)
Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Treatment Period
STARTED
|
32
|
35
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
Received at Least One Dose of Study Drug
|
32
|
35
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
COMPLETED
|
19
|
22
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
NOT COMPLETED
|
13
|
13
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period
STARTED
|
0
|
0
|
0
|
8
|
10
|
5
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
8
|
10
|
5
|
0
|
0
|
0
|
0
|
|
Extension Treatment Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
0
|
0
|
0
|
|
Extension Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
0
|
0
|
0
|
|
Post-Treatment Follow-up Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
30
|
11
|
|
Post-Treatment Follow-up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-Treatment Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
30
|
11
|
Reasons for withdrawal
| Measure |
High Dose LY3471851 (Induction Treatment Period)
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Placebo (Induction Treatment Period)
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Maintenance Treatment Period)
Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Low Dose LY3471851 (Maintenance Treatment Period)
Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Placebo (Maintenance Treatment Period)
Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.
|
High Dose LY3471851 (Extension Treatment Period)
Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
|
High Dose LY3471851 (Post-Treatment Follow-up Period)
Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Low Dose LY3471851 (Post-Treatment Follow-up Period)
Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Placebo (Post-Treatment Follow-up Period)
Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Treatment Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
Physician Decision
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
Withdrawal by Subject
|
4
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Treatment Period
Study terminated by sponsor
|
7
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period
Study terminated by sponsor
|
0
|
0
|
0
|
7
|
9
|
5
|
0
|
0
|
0
|
0
|
|
Extension Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Extension Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Extension Treatment Period
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
0
|
0
|
0
|
|
Post-Treatment Follow-up Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Post-Treatment Follow-up Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
0
|
|
Post-Treatment Follow-up Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Post-Treatment Follow-up Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
|
Post-Treatment Follow-up Period
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
26
|
11
|
Baseline Characteristics
All randomized participants with non-missing region of enrollment data.
Baseline characteristics by cohort
| Measure |
High Dose LY3471851 (Induction Treatment Period)
n=32 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=35 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 12.5 • n=32 Participants
|
44.5 years
STANDARD_DEVIATION 13.8 • n=35 Participants
|
45.7 years
STANDARD_DEVIATION 15.2 • n=14 Participants
|
42.6 years
STANDARD_DEVIATION 13.7 • n=81 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=32 Participants
|
9 Participants
n=35 Participants
|
6 Participants
n=14 Participants
|
25 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=32 Participants
|
26 Participants
n=35 Participants
|
8 Participants
n=14 Participants
|
56 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=32 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=14 Participants
|
11 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=32 Participants
|
31 Participants
n=35 Participants
|
12 Participants
n=14 Participants
|
68 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=81 Participants
|
|
Region of Enrollment
Argentina
|
2 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
4 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Australia
|
0 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
0 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Belgium
|
0 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
0 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Czechia
|
2 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
4 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
0 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
6 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Hungary
|
3 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
3 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
0 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
6 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Japan
|
3 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
5 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
South Korea
|
1 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
3 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
5 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Latvia
|
2 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
3 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
0 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
5 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Poland
|
2 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
2 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
5 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Russia
|
5 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
5 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
3 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
13 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Slovakia
|
1 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
3 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
Ukraine
|
7 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
7 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
4 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
18 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
|
Region of Enrollment
United States
|
3 Participants
n=31 Participants • All randomized participants with non-missing region of enrollment data.
|
4 Participants
n=35 Participants • All randomized participants with non-missing region of enrollment data.
|
1 Participants
n=14 Participants • All randomized participants with non-missing region of enrollment data.
|
8 Participants
n=80 Participants • All randomized participants with non-missing region of enrollment data.
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
|
14.3 percentage of participants
Interval 0.0 to 32.6
|
7.1 percentage of participants
Interval 0.0 to 16.7
|
17.2 percentage of participants
Interval 3.5 to 31.0
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Clinical Response at Week 12
|
35.7 percentage of participants
Interval 10.6 to 60.8
|
39.3 percentage of participants
Interval 21.2 to 57.4
|
41.4 percentage of participants
Interval 23.5 to 59.3
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Endoscopic Remission at Week 12
|
28.6 percentage of participants
Interval 4.9 to 52.2
|
14.3 percentage of participants
Interval 1.3 to 27.2
|
24.1 percentage of participants
Interval 8.6 to 39.7
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Endoscopic Response at Week 12
|
21.4 percentage of participants
Interval 0.0 to 42.9
|
32.1 percentage of participants
Interval 14.8 to 49.4
|
37.9 percentage of participants
Interval 20.3 to 55.6
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Symptomatic Remission at Week 12
|
21.4 percentage of participants
Interval 0.0 to 42.9
|
32.1 percentage of participants
Interval 14.8 to 49.4
|
27.6 percentage of participants
Interval 11.3 to 43.9
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had MMS data at week 12.
Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Symptomatic Response at Week 12
|
42.9 percentage of participants
Interval 16.9 to 68.8
|
42.9 percentage of participants
Interval 24.5 to 61.2
|
44.8 percentage of participants
Interval 26.7 to 62.9
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had Geboes data at week 12.
Histologic Remission is defined as Geboes score \<2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=\>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Histologic Remission at Week 12
|
7.1 percentage of participants
Interval 0.0 to 20.6
|
7.1 percentage of participants
Interval 0.0 to 16.7
|
10.3 percentage of participants
Interval 0.0 to 21.4
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had Geboes, MMS data at week 12.
HEMH is defined as Geboes score \<2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=\>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=14 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=28 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)
|
0 percentage of participants
Interval 0.0 to 0.0
|
3.6 percentage of participants
Interval 0.0 to 10.4
|
6.9 percentage of participants
Interval 0.0 to 16.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of study drug and had IBDQ data at baseline, week 12.
IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: \[4 to 6\] or \[7 to 9\]) and region (North America/Europe/Other) as fixed factors.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=13 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=26 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
n=29 Participants
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score
|
26.71 score on a scale
Standard Error 9.346
|
36.42 score on a scale
Standard Error 7.640
|
25.76 score on a scale
Standard Error 7.143
|
SECONDARY outcome
Timeframe: Predose at week 12Population: All participants who received at least 1 dose of LY3471851 and had evaluable PK data.
C-trough is the concentration of drug in the blood immediately before the next dose was administered.
Outcome measures
| Measure |
Placebo (Induction Treatment Period)
n=26 Participants
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=26 Participants
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Induction Treatment Period)
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12
|
91.3 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 49
|
139 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 105
|
—
|
Adverse Events
High Dose LY3471851 (Induction Treatment Period)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Low Dose LY3471851 (Induction Treatment Period)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo (Induction Treatment Period)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
High Dose LY3471851 (Maintenance Treatment Period)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low Dose LY3471851 (Maintenance Treatment Period)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (Maintenance Treatment Period)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Dose LY3471851 (Extension Treatment Period)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
High Dose LY3471851 (Post-Treatment Follow-up Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose LY3471851 (Post-Treatment Follow-up Period)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Post-Treatment Follow-up Period)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose LY3471851 (Induction Treatment Period)
n=32 participants at risk
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=35 participants at risk
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Placebo (Induction Treatment Period)
n=14 participants at risk
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Maintenance Treatment Period)
n=8 participants at risk
Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Low Dose LY3471851 (Maintenance Treatment Period)
n=10 participants at risk
Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Placebo (Maintenance Treatment Period)
n=5 participants at risk
Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.
|
High Dose LY3471851 (Extension Treatment Period)
n=26 participants at risk
Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
|
High Dose LY3471851 (Post-Treatment Follow-up Period)
n=25 participants at risk
Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Low Dose LY3471851 (Post-Treatment Follow-up Period)
n=30 participants at risk
Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Placebo (Post-Treatment Follow-up Period)
n=11 participants at risk
Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Proctitis
|
3.1%
1/32 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
High Dose LY3471851 (Induction Treatment Period)
n=32 participants at risk
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Low Dose LY3471851 (Induction Treatment Period)
n=35 participants at risk
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
|
Placebo (Induction Treatment Period)
n=14 participants at risk
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
|
High Dose LY3471851 (Maintenance Treatment Period)
n=8 participants at risk
Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Low Dose LY3471851 (Maintenance Treatment Period)
n=10 participants at risk
Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
|
Placebo (Maintenance Treatment Period)
n=5 participants at risk
Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.
|
High Dose LY3471851 (Extension Treatment Period)
n=26 participants at risk
Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
|
High Dose LY3471851 (Post-Treatment Follow-up Period)
n=25 participants at risk
Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Low Dose LY3471851 (Post-Treatment Follow-up Period)
n=30 participants at risk
Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
Placebo (Post-Treatment Follow-up Period)
n=11 participants at risk
Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.7%
2/26 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 3 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Application site reaction
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
5.7%
2/35 • Number of events 5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 6 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Hyperthermia
|
6.2%
2/32 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 4 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
25.0%
8/32 • Number of events 21 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
17.1%
6/35 • Number of events 20 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 12 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.7%
2/26 • Number of events 9 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
21.9%
7/32 • Number of events 9 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 4 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
6.2%
2/32 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
8.6%
3/35 • Number of events 3 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.7%
2/26 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
5.7%
2/35 • Number of events 3 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 12 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Body temperature increased
|
12.5%
4/32 • Number of events 11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 3 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Number of events 2 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.1%
1/32 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.4%
3/32 • Number of events 5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
2.9%
1/35 • Number of events 3 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/32 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/26 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/30 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline to Follow-up (Up To Week 58)
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60