Trial Outcomes & Findings for Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (NCT NCT03341962)

NCT ID: NCT03341962

Last Updated: 2024-03-05

Results Overview

Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10. All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 263 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2024-03-05

Participant Flow

The study had 3 phases, induction, maintenance and open-label. Patients who achieved symptomatic remission at Week 10 or 22 (extended) of induction phase (IP) could proceed to maintenance phase (MP). Patients who were treated for at least 6 weeks in the induction phase and fulfilled further eligibility criteria could proceed into the open label treatment extension phase (OLE).

Participant milestones

Measure	10 mg IMU-838 (Induction Phase) Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients received only half of their assigned full dose during the first week of treatment.	30 mg IMU-838 (Induction Phase) Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients received only half of their assigned full dose during the first week of treatment.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients receivec only half of their assigned full dose during the first week of treatment.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients received only half of their assigned full dose during the first week of treatment.	10 mg IMU-838 (Maintenance Phase) Two 5 mg tablets once daily of IMU-838 for up to 40 weeks.	30 mg IMU-383 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks.	30 mg IMU-838 (Open-label Phase) Two 15 mg tablets once daily of IMU-838.
Induction Phase STARTED	67	67	66	63	0	0	0	0
Induction Phase COMPLETED	53	48	50	52	0	0	0	0
Induction Phase NOT COMPLETED	14	19	16	11	0	0	0	0
Maintenance Phase STARTED	0	0	0	0	45	40	27	0
Maintenance Phase COMPLETED	0	0	0	0	35	29	21	0
Maintenance Phase NOT COMPLETED	0	0	0	0	10	11	6	0
Open-label Phase STARTED	0	0	0	0	0	0	0	190
Open-label Phase COMPLETED	0	0	0	0	0	0	0	0
Open-label Phase NOT COMPLETED	0	0	0	0	0	0	0	190

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FAS

Baseline characteristics by cohort

Measure	10 mg IMU-838 (Induction Phase) n=67 Participants Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Induction Phase) n=66 Participants Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	10 mg IMU-838 (Maintenance Phase n=45 Participants Two 5 mg tablets once daily of IMU-838 for up to 50 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 50 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 50 weeks.	30 mg IMU-838 (Open-label Phase) n=190 Participants Two 15 mg tablets once daily of IMU-838.	Total n=565 Participants Total of all reporting groups
Age, Continuous Induction Phase	40.0 years n=67 Participants • FAS	41.0 years n=66 Participants • FAS	40.5 years n=66 Participants • FAS	38.5 years n=64 Participants • FAS	—	—	—	—	40.0 years n=263 Participants • FAS
Age, Continuous Maintenance phase	—	—	—	—	37.0 years n=45 Participants • FAS	39.5 years n=40 Participants • FAS	38.0 years n=27 Participants • FAS	—	38.0 years n=112 Participants • FAS
Age, Continuous Open-label phase	—	—	—	—	—	—	—	39.5 years n=190 Participants • FAS	39.5 years n=190 Participants • FAS
Sex: Female, Male Induction phase · Female	32 Participants n=67 Participants • FAS	26 Participants n=66 Participants • FAS	26 Participants n=66 Participants • FAS	31 Participants n=64 Participants • FAS	—	—	—	—	115 Participants n=263 Participants • FAS
Sex: Female, Male Induction phase · Male	35 Participants n=67 Participants • FAS	40 Participants n=66 Participants • FAS	40 Participants n=66 Participants • FAS	33 Participants n=64 Participants • FAS	—	—	—	—	148 Participants n=263 Participants • FAS
Sex: Female, Male Maintenance phase · Female	—	—	—	—	15 Participants n=45 Participants • FAS	25 Participants n=40 Participants • FAS	9 Participants n=27 Participants • FAS	—	49 Participants n=112 Participants • FAS
Sex: Female, Male Maintenance phase · Male	—	—	—	—	30 Participants n=45 Participants • FAS	15 Participants n=40 Participants • FAS	18 Participants n=27 Participants • FAS	—	63 Participants n=112 Participants • FAS
Sex: Female, Male Open-label phase · Female	—	—	—	—	—	—	—	83 Participants n=190 Participants • FAS	83 Participants n=190 Participants • FAS
Sex: Female, Male Open-label phase · Male	—	—	—	—	—	—	—	107 Participants n=190 Participants • FAS	107 Participants n=190 Participants • FAS
Ethnicity (NIH/OMB) Induction phase · Hispanic or Latino	0 Participants n=67 Participants • FAS	1 Participants n=66 Participants • FAS	0 Participants n=66 Participants • FAS	3 Participants n=64 Participants • FAS	—	—	—	—	4 Participants n=263 Participants • FAS
Ethnicity (NIH/OMB) Induction phase · Not Hispanic or Latino	67 Participants n=67 Participants • FAS	65 Participants n=66 Participants • FAS	66 Participants n=66 Participants • FAS	61 Participants n=64 Participants • FAS	—	—	—	—	259 Participants n=263 Participants • FAS
Ethnicity (NIH/OMB) Induction phase · Unknown or Not Reported	0 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	0 Participants n=263 Participants • FAS
Ethnicity (NIH/OMB) Maintenance phase · Hispanic or Latino	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Ethnicity (NIH/OMB) Maintenance phase · Not Hispanic or Latino	—	—	—	—	45 Participants n=45 Participants • FAS	40 Participants n=40 Participants • FAS	27 Participants n=27 Participants • FAS	—	112 Participants n=112 Participants • FAS
Ethnicity (NIH/OMB) Maintenance phase · Unknown or Not Reported	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Ethnicity (NIH/OMB) Open-label phase · Hispanic or Latino	—	—	—	—	—	—	—	3 Participants n=190 Participants • FAS	3 Participants n=190 Participants • FAS
Ethnicity (NIH/OMB) Open-label phase · Not Hispanic or Latino	—	—	—	—	—	—	—	187 Participants n=190 Participants • FAS	187 Participants n=190 Participants • FAS
Ethnicity (NIH/OMB) Open-label phase · Unknown or Not Reported	—	—	—	—	—	—	—	0 Participants n=190 Participants • FAS	0 Participants n=190 Participants • FAS
Race (NIH/OMB) Induction phase · American Indian or Alaska Native	0 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	0 Participants n=263 Participants • FAS
Race (NIH/OMB) Induction phase · Asian	1 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	1 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	2 Participants n=263 Participants • FAS
Race (NIH/OMB) Induction phase · Native Hawaiian or Other Pacific Islander	0 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	0 Participants n=263 Participants • FAS
Race (NIH/OMB) Induction phase · Black or African American	2 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	2 Participants n=263 Participants • FAS
Race (NIH/OMB) Induction phase · White	64 Participants n=67 Participants • FAS	66 Participants n=66 Participants • FAS	64 Participants n=66 Participants • FAS	64 Participants n=64 Participants • FAS	—	—	—	—	258 Participants n=263 Participants • FAS
Race (NIH/OMB) Induction phase · More than one race	0 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	1 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	1 Participants n=263 Participants • FAS
Race (NIH/OMB) Induction phase · Unknown or Not Reported	0 Participants n=67 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=66 Participants • FAS	0 Participants n=64 Participants • FAS	—	—	—	—	0 Participants n=263 Participants • FAS
Race (NIH/OMB) Maintenance phase · American Indian or Alaska Native	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Race (NIH/OMB) Maintenance phase · Asian	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Race (NIH/OMB) Maintenance phase · Native Hawaiian or Other Pacific Islander	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Race (NIH/OMB) Maintenance phase · Black or African American	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Race (NIH/OMB) Maintenance phase · White	—	—	—	—	45 Participants n=45 Participants • FAS	40 Participants n=40 Participants • FAS	27 Participants n=27 Participants • FAS	—	112 Participants n=112 Participants • FAS
Race (NIH/OMB) Maintenance phase · More than one race	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Race (NIH/OMB) Maintenance phase · Unknown or Not Reported	—	—	—	—	0 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	0 Participants n=112 Participants • FAS
Race (NIH/OMB) Open-label phase · American Indian or Alaska Native	—	—	—	—	—	—	—	0 Participants n=190 Participants • FAS	0 Participants n=190 Participants • FAS
Race (NIH/OMB) Open-label phase · Asian	—	—	—	—	—	—	—	1 Participants n=190 Participants • FAS	1 Participants n=190 Participants • FAS
Race (NIH/OMB) Open-label phase · Native Hawaiian or Other Pacific Islander	—	—	—	—	—	—	—	0 Participants n=190 Participants • FAS	0 Participants n=190 Participants • FAS
Race (NIH/OMB) Open-label phase · Black or African American	—	—	—	—	—	—	—	1 Participants n=190 Participants • FAS	1 Participants n=190 Participants • FAS
Race (NIH/OMB) Open-label phase · White	—	—	—	—	—	—	—	187 Participants n=190 Participants • FAS	187 Participants n=190 Participants • FAS
Race (NIH/OMB) Open-label phase · More than one race	—	—	—	—	—	—	—	1 Participants n=190 Participants • FAS	1 Participants n=190 Participants • FAS
Race (NIH/OMB) Open-label phase · Unknown or Not Reported	—	—	—	—	—	—	—	0 Participants n=190 Participants • FAS	0 Participants n=190 Participants • FAS
Region of Enrollment Romania	0 participants n=67 Participants	0 participants n=66 Participants	1 participants n=66 Participants	0 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	0 participants n=27 Participants	0 participants n=190 Participants	1 participants n=565 Participants
Region of Enrollment United States	5 participants n=67 Participants	3 participants n=66 Participants	1 participants n=66 Participants	3 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	0 participants n=27 Participants	8 participants n=190 Participants	12 participants n=565 Participants
Region of Enrollment Czechia	4 participants n=67 Participants	1 participants n=66 Participants	3 participants n=66 Participants	1 participants n=64 Participants	0 participants n=45 Participants	1 participants n=40 Participants	1 participants n=27 Participants	9 participants n=190 Participants	9 participants n=565 Participants
Region of Enrollment Ukraine	21 participants n=67 Participants	21 participants n=66 Participants	18 participants n=66 Participants	25 participants n=64 Participants	20 participants n=45 Participants	14 participants n=40 Participants	14 participants n=27 Participants	66 participants n=190 Participants	85 participants n=565 Participants
Region of Enrollment United Kingdom	4 participants n=67 Participants	2 participants n=66 Participants	0 participants n=66 Participants	4 participants n=64 Participants	1 participants n=45 Participants	0 participants n=40 Participants	2 participants n=27 Participants	9 participants n=190 Participants	10 participants n=565 Participants
Region of Enrollment Belarus	3 participants n=67 Participants	1 participants n=66 Participants	2 participants n=66 Participants	0 participants n=64 Participants	2 participants n=45 Participants	2 participants n=40 Participants	0 participants n=27 Participants	4 participants n=190 Participants	6 participants n=565 Participants
Region of Enrollment Portugal	0 participants n=67 Participants	1 participants n=66 Participants	0 participants n=66 Participants	1 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	1 participants n=27 Participants	1 participants n=190 Participants	2 participants n=565 Participants
Region of Enrollment Albania	3 participants n=67 Participants	2 participants n=66 Participants	3 participants n=66 Participants	5 participants n=64 Participants	0 participants n=45 Participants	4 participants n=40 Participants	3 participants n=27 Participants	2 participants n=190 Participants	13 participants n=565 Participants
Region of Enrollment Russia	3 participants n=67 Participants	5 participants n=66 Participants	10 participants n=66 Participants	8 participants n=64 Participants	4 participants n=45 Participants	4 participants n=40 Participants	1 participants n=27 Participants	20 participants n=190 Participants	26 participants n=565 Participants
Region of Enrollment Spain	0 participants n=67 Participants	0 participants n=66 Participants	1 participants n=66 Participants	0 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	0 participants n=27 Participants	0 participants n=190 Participants	1 participants n=565 Participants
Region of Enrollment Netherlands	1 participants n=67 Participants	0 participants n=66 Participants	2 participants n=66 Participants	1 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	0 participants n=27 Participants	2 participants n=190 Participants	4 participants n=565 Participants
Region of Enrollment North Macedonia	5 participants n=67 Participants	2 participants n=66 Participants	2 participants n=66 Participants	1 participants n=64 Participants	1 participants n=45 Participants	1 participants n=40 Participants	0 participants n=27 Participants	6 participants n=190 Participants	10 participants n=565 Participants
Region of Enrollment Poland	11 participants n=67 Participants	20 participants n=66 Participants	12 participants n=66 Participants	12 participants n=64 Participants	9 participants n=45 Participants	9 participants n=40 Participants	4 participants n=27 Participants	42 participants n=190 Participants	55 participants n=565 Participants
Region of Enrollment Bulgaria	1 participants n=67 Participants	0 participants n=66 Participants	1 participants n=66 Participants	1 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	1 participants n=27 Participants	3 participants n=190 Participants	3 participants n=565 Participants
Region of Enrollment Serbia	5 participants n=67 Participants	4 participants n=66 Participants	5 participants n=66 Participants	2 participants n=64 Participants	4 participants n=45 Participants	4 participants n=40 Participants	0 participants n=27 Participants	11 participants n=190 Participants	16 participants n=565 Participants
Region of Enrollment Bosnia and Herzegovina	1 participants n=67 Participants	2 participants n=66 Participants	2 participants n=66 Participants	0 participants n=64 Participants	4 participants n=45 Participants	1 participants n=40 Participants	0 participants n=27 Participants	3 participants n=190 Participants	5 participants n=565 Participants
Region of Enrollment Croatia	0 participants n=67 Participants	2 participants n=66 Participants	3 participants n=66 Participants	0 participants n=64 Participants	0 participants n=45 Participants	0 participants n=40 Participants	0 participants n=27 Participants	4 participants n=190 Participants	5 participants n=565 Participants
Duration of disease	7.5 years STANDARD_DEVIATION 7.6 • n=67 Participants • FAS, Duration of disease was only reported at Induction phase Baseline.	5.8 years STANDARD_DEVIATION 5.4 • n=66 Participants • FAS, Duration of disease was only reported at Induction phase Baseline.	7.1 years STANDARD_DEVIATION 7.4 • n=66 Participants • FAS, Duration of disease was only reported at Induction phase Baseline.	5.2 years STANDARD_DEVIATION 4.6 • n=64 Participants • FAS, Duration of disease was only reported at Induction phase Baseline.	—	—	—	—	6.4 years STANDARD_DEVIATION 6.4 • n=263 Participants • FAS, Duration of disease was only reported at Induction phase Baseline.
Current tobacco users Induction phase	2 Participants n=67 Participants • FAS	5 Participants n=66 Participants • FAS	2 Participants n=66 Participants • FAS	4 Participants n=64 Participants • FAS	—	—	—	—	13 Participants n=263 Participants • FAS
Current tobacco users Maintenance phase	—	—	—	—	1 Participants n=45 Participants • FAS	0 Participants n=40 Participants • FAS	0 Participants n=27 Participants • FAS	—	1 Participants n=112 Participants • FAS
Current tobacco users Open-label phase	—	—	—	—	—	—	—	10 Participants n=190 Participants • FAS	10 Participants n=190 Participants • FAS
Mayo PRO-2 Score at Basline Induction phase	4.1 units on a scale STANDARD_DEVIATION 1.2 • n=67 Participants • FAS	4.3 units on a scale STANDARD_DEVIATION 1.0 • n=65 Participants • FAS	4.3 units on a scale STANDARD_DEVIATION 1.0 • n=66 Participants • FAS	4.3 units on a scale STANDARD_DEVIATION 0.9 • n=64 Participants • FAS	—	—	—	—	4.2 units on a scale STANDARD_DEVIATION 1.0 • n=262 Participants • FAS
Mayo PRO-2 Score at Basline Maintenance phase	—	—	—	—	0.8 units on a scale STANDARD_DEVIATION 0.5 • n=45 Participants • FAS	0.9 units on a scale STANDARD_DEVIATION 0.8 • n=40 Participants • FAS	0.7 units on a scale STANDARD_DEVIATION 0.5 • n=27 Participants • FAS	—	0.8 units on a scale STANDARD_DEVIATION 0.6 • n=112 Participants • FAS
Mayo PRO-2 Score at Basline Open-label phase (Entry in open label after induction phase)	—	—	—	—	—	—	—	3.9 units on a scale STANDARD_DEVIATION 1.2 • n=115 Participants • FAS	3.9 units on a scale STANDARD_DEVIATION 1.2 • n=115 Participants • FAS
Mayo PRO-2 Score at Basline Open-label phase (Entry in open label after maintenance phase)	—	—	—	—	—	—	—	1.6 units on a scale STANDARD_DEVIATION 1.7 • n=75 Participants • FAS	1.6 units on a scale STANDARD_DEVIATION 1.7 • n=75 Participants • FAS

PRIMARY outcome

Timeframe: 10 weeks

Population: FAS

Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10.

All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=116 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=57 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10	16 Participants	8 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 10 weeks

Population: FAS

Proportion of patients with both symptomatic remission and endoscopic healing at Week 10 (all individual IMU-838 doses were compared with one another and to placebo)

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=62 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=56 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=60 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=57 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Symptomatic Remission and Endoscopic Healing at Different Doses at Week 10	10 Participants	7 Participants	9 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Proportion of patients achieving symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) during the induction phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=128 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=62 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=64 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Symptomatic Remission	56 Participants	28 Participants	38 Participants	25 Participants	31 Participants	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Time to achieving symptomatic remission (Mayo rectal bleeding subscore = 0 and Mayo stool frequency subscore of 0 or 1) within the extended induction phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=132 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=67 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=66 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Time to Achieving Symptomatic Remission	108.8 days Standard Error 5.5	119.6 days Standard Error 7.1	98 days Standard Error 7.7	115.9 days Standard Error 7.4	101.9 days Standard Error 8.1	—	—

SECONDARY outcome

Timeframe: 10 weeks

Population: FAS

Proportion of patients with clinical response (decrease from Baseline in the full Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1) at Week 10

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=114 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=57 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=61 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=55 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=59 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Proportion of Patients With Clinical Response	50 Participants	27 Participants	31 Participants	23 Participants	27 Participants	—	—

SECONDARY outcome

Timeframe: 10 weeks

Population: FAS

Proportion of patients with endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=112 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=57 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=61 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=53 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=59 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Proportion of Patients With Endoscopic Healing	28 Participants	12 Participants	18 Participants	14 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Proportion of patients with symptomatic response (≥1-point decrease from Baseline in Mayo PRO-2 score) during the induction phase (including extended induction phase)

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=128 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=62 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=64 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Proportion of Patients With Symptomatic Response	101 Participants	49 Participants	55 Participants	52 Participants	49 Participants	—	—

SECONDARY outcome

Timeframe: 10 weeks

Population: FAS

Change in full Mayo Score from Baseline to Week 10. The full Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 12. A higher score indicates a worse outcome.

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=132 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=67 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=66 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Full Mayo Score Baseline	9.1 score on a scale Standard Deviation 1.4	9.1 score on a scale Standard Deviation 1.4	9.0 score on a scale Standard Deviation 1.6	9.1 score on a scale Standard Deviation 1.4	9.1 score on a scale Standard Deviation 1.4	—	—
Induction Phase: Full Mayo Score Change from Baseline to Week 10	-2.6 score on a scale Standard Deviation 2.7	-2.3 score on a scale Standard Deviation 2.7	-3.0 score on a scale Standard Deviation 2.6	-2.5 score on a scale Standard Deviation 2.7	-2.8 score on a scale Standard Deviation 2.7	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Change in partial mayo score over 10 or 22 weeks. The partial Mayo score includes only the non-invasive Mayo subscores, ie, stool frequency, rectal bleeding, and physician's global assessment (each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 9). A higher score indicates a worse outcome.

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=132 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=67 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=66 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Partial Mayo Score Baseline (all patients)	6.6 score on a scale Standard Deviation 1.2	6.5 score on a scale Standard Deviation 1.1	6.4 score on a scale Standard Deviation 1.4	6.5 score on a scale Standard Deviation 1.2	6.6 score on a scale Standard Deviation 1.2	—	—
Induction Phase: Partial Mayo Score Change from Baseline to Week 10 (all patients)	-2.2 score on a scale Standard Deviation 2.2	-1.9 score on a scale Standard Deviation 2.2	-2.4 score on a scale Standard Deviation 2.2	-1.9 score on a scale Standard Deviation 2.0	-2.4 score on a scale Standard Deviation 2.3	—	—
Induction Phase: Partial Mayo Score Baseline (only patients who entered extended induction phase)	6.6 score on a scale Standard Deviation 1.2	6.5 score on a scale Standard Deviation 1.0	6.6 score on a scale Standard Deviation 1.3	6.6 score on a scale Standard Deviation 1.2	6.7 score on a scale Standard Deviation 1.2	—	—
Induction Phase: Partial Mayo Score Change from Baseline to Week 22 (only patients who entered extended induction phase)	-3.5 score on a scale Standard Deviation 2.1	-3.6 score on a scale Standard Deviation 2.2	-3.4 score on a scale Standard Deviation 2.3	-3.7 score on a scale Standard Deviation 2.2	-3.3 score on a scale Standard Deviation 2.0	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Change in PRO-2 Mayo score over 10 or 22 weeks. Mayo PRO-2 score, ie, stool frequency and rectal bleeding score each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 6. A higher score indicates a worse outcome.

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=132 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=67 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=66 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Patient Reported Outcome (PRO)-2 Mayo Score Baseline (all patients)	4.3 score on a scale Standard Deviation 1.0	4.3 score on a scale Standard Deviation 0.9	4.1 score on a scale Standard Deviation 1.2	4.3 score on a scale Standard Deviation 1.0	4.3 score on a scale Standard Deviation 1.0	—	—
Induction Phase: Patient Reported Outcome (PRO)-2 Mayo Score Change from Baseline to Week 10 (all patients)	-1.6 score on a scale Standard Deviation 1.7	-1.4 score on a scale Standard Deviation 1.7	-1.7 score on a scale Standard Deviation 1.6	-1.4 score on a scale Standard Deviation 1.6	-1.8 score on a scale Standard Deviation 1.7	—	—
Induction Phase: Patient Reported Outcome (PRO)-2 Mayo Score Baseline (only patients who entered extended induction phase)	4.3 score on a scale Standard Deviation 1.0	4.3 score on a scale Standard Deviation 0.8	4.2 score on a scale Standard Deviation 1.1	4.3 score on a scale Standard Deviation 1.1	4.3 score on a scale Standard Deviation 1.0	—	—
Induction Phase: Patient Reported Outcome (PRO)-2 Mayo Score Change from Baseline to Week 22 (only patients who entered extended induction phase)	-2.5 score on a scale Standard Deviation 1.6	-2.6 score on a scale Standard Deviation 1.6	-2.4 score on a scale Standard Deviation 1.8	-2.7 score on a scale Standard Deviation 1.6	-2.3 score on a scale Standard Deviation 1.6	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Time course of biomarker fCP in stool samples during extended induction phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=132 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=67 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=66 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: Fecal Calprotectin (fCP) Week 10 (all patients	290.0 mg/kg Interval 13.0 to 6731.0	405.0 mg/kg Interval 9.0 to 17819.0	384.0 mg/kg Interval 3.0 to 19955.0	301.5 mg/kg Interval 13.0 to 5269.0	265.0 mg/kg Interval 17.0 to 6731.0	—	—
Induction Phase: Fecal Calprotectin (fCP) Day 0 (all patients)	799.0 mg/kg Interval 9.0 to 10437.0	899.0 mg/kg Interval 39.0 to 5323.0	697.0 mg/kg Interval 3.0 to 4064.0	711.5 mg/kg Interval 55.0 to 10437.0	992.0 mg/kg Interval 9.0 to 8310.0	—	—
Induction Phase: Fecal Calprotectin (fCP) Day 0 (Only patients who entered extended induction phase)	616.5 mg/kg Interval 9.0 to 10437.0	1039.0 mg/kg Interval 46.0 to 5323.0	603.0 mg/kg Interval 60.0 to 2536.0	547.0 mg/kg Interval 115.0 to 10437.0	856.5 mg/kg Interval 9.0 to 8310.0	—	—
Induction Phase: Fecal Calprotectin (fCP) Week 22 (Only patients who entered extended induction phase)	332.0 mg/kg Interval 6.0 to 6699.0	387.0 mg/kg Interval 38.0 to 4183.0	353.0 mg/kg Interval 20.0 to 1515.0	314.0 mg/kg Interval 6.0 to 1124.0	576.0 mg/kg Interval 16.0 to 6699.0	—	—

SECONDARY outcome

Timeframe: 22 weeks

Population: FAS

Time course of biomarker CRP in blood samples during extended induction phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=132 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=64 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=67 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=66 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Induction Phase: C-reactive Protein (CRP) Day 0 (Only patients who entered extended induction phase)	3.65 mg/L Interval 0.3 to 113.8	2.40 mg/L Interval 0.3 to 78.6	5.55 mg/L Interval 0.3 to 61.4	3.05 mg/L Interval 0.3 to 113.8	7.85 mg/L Interval 0.3 to 80.0	—	—
Induction Phase: C-reactive Protein (CRP) Week 22 (Only patients who entered extended induction phase)	2.70 mg/L Interval 0.3 to 23.7	1.25 mg/L Interval 0.3 to 69.9	2.80 mg/L Interval 0.3 to 17.8	2.00 mg/L Interval 0.3 to 13.0	2.75 mg/L Interval 0.3 to 23.7	—	—
Induction Phase: C-reactive Protein (CRP) Day 0 (all patients)	3.50 mg/L Interval 0.3 to 122.3	3.2 mg/L Interval 0.3 to 81.1	5.30 mg/L Interval 0.3 to 79.8	3.70 mg/L Interval 0.3 to 122.3	3.50 mg/L Interval 0.3 to 80.0	—	—
Induction Phase: C-reactive Protein (CRP) Week 10 (all patients)	3.40 mg/L Interval 0.3 to 33.9	1.85 mg/L Interval 0.3 to 50.8	4.00 mg/L Interval 0.3 to 46.0	3.50 mg/L Interval 0.3 to 26.3	2.75 mg/L Interval 0.3 to 33.9	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Incidence and Severity of AEs during the induction and maintenance phases

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Adverse Events Any TEAE	28 Participants	30 Participants	30 Participants	23 Participants	16 Participants	16 Participants	12 Participants
Safety: Adverse Events Any mild TEAE	23 Participants	21 Participants	24 Participants	15 Participants	11 Participants	12 Participants	8 Participants
Safety: Adverse Events Any moderate TEAE	7 Participants	10 Participants	11 Participants	13 Participants	5 Participants	7 Participants	4 Participants
Safety: Adverse Events Any severe TEAE	2 Participants	3 Participants	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

The emergence of any clinically significant findings compared to screening captured during the induction and maintenance phases

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Number of Participants With Clinically Significant Findings During Physical Examination	0 Participants	3 Participants	4 Participants	0 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Changes in body weight during the induction and maintenance phases

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Body Weight Induction phase - Week 22	70.310 kg Standard Deviation 13.640	74.689 kg Standard Deviation 15.143	75.188 kg Standard Deviation 18.202	69.635 kg Standard Deviation 14.425	—	—	—
Safety: Body Weight Maintenance phase - Baseline	—	—	—	—	74.431 kg Standard Deviation 13.081	70.490 kg Standard Deviation 16.480	72.441 kg Standard Deviation 13.259
Safety: Body Weight Maintenance phase - Week 50	—	—	—	—	75.743 kg Standard Deviation 13.452	73.986 kg Standard Deviation 18.069	70.310 kg Standard Deviation 11.458
Safety: Body Weight Induction phase - Day 0	73.881 kg Standard Deviation 19.479	72.436 kg Standard Deviation 15.348	73.959 kg Standard Deviation 13.915	70.141 kg Standard Deviation 15.754	—	—	—
Safety: Body Weight Induction phase - Week 10	73.747 kg Standard Deviation 20.030	71.457 kg Standard Deviation 14.522	75.094 kg Standard Deviation 14.148	71.437 kg Standard Deviation 15.998	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Changes in blood pressure (mm Hg) during the induction and maintenance phases

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Blood Pressure Induction phase - Day 0 (systolic blood pressure)	123.2 mmHg Standard Deviation 14.2	125.1 mmHg Standard Deviation 12.8	123.2 mmHg Standard Deviation 11.4	121.9 mmHg Standard Deviation 11.8	—	—	—
Safety: Blood Pressure Induction phase - Week 10 (systolic blood pressure)	123.1 mmHg Standard Deviation 11.4	123.8 mmHg Standard Deviation 13.2	121.7 mmHg Standard Deviation 9.7	122.0 mmHg Standard Deviation 12.8	—	—	—
Safety: Blood Pressure Induction phase - Week 22 (systolic blood pressure)	118.3 mmHg Standard Deviation 10.2	126.7 mmHg Standard Deviation 12.3	119.8 mmHg Standard Deviation 6.6	121.8 mmHg Standard Deviation 12.3	—	—	—
Safety: Blood Pressure Induction phase - Day 0 (diastolic blood pressure)	76.2 mmHg Standard Deviation 10.8	78.1 mmHg Standard Deviation 10.3	79.5 mmHg Standard Deviation 9.4	74.9 mmHg Standard Deviation 8.2	—	—	—
Safety: Blood Pressure Induction phase - Week 10 (diastolic blood pressure)	76.1 mmHg Standard Deviation 9.1	79.5 mmHg Standard Deviation 9.2	77.3 mmHg Standard Deviation 7.9	75.5 mmHg Standard Deviation 7.9	—	—	—
Safety: Blood Pressure Induction phase - Week 22 (diastolic blood pressure)	72.0 mmHg Standard Deviation 7.6	77.6 mmHg Standard Deviation 7.4	75.4 mmHg Standard Deviation 6.5	74.2 mmHg Standard Deviation 9.8	—	—	—
Safety: Blood Pressure Maintenance phase - baseline (systolic blood pressure)	—	—	—	—	121.3 mmHg Standard Deviation 10.6	123.7 mmHg Standard Deviation 12.2	124.1 mmHg Standard Deviation 13.0
Safety: Blood Pressure Maintenance phase - Week 50 (systolic blood pressure)	—	—	—	—	122.0 mmHg Standard Deviation 13.0	125.3 mmHg Standard Deviation 14.3	122.6 mmHg Standard Deviation 9.2
Safety: Blood Pressure Maintenance phase - baseline (diastolic blood pressure)	—	—	—	—	75.2 mmHg Standard Deviation 8.7	76.5 mmHg Standard Deviation 9.5	75.1 mmHg Standard Deviation 8.8
Safety: Blood Pressure Maintenance phase - Week 50 (diastolic blood pressure	—	—	—	—	76.5 mmHg Standard Deviation 9.9	77.1 mmHg Standard Deviation 9.0	74.7 mmHg Standard Deviation 6.4

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Changes in heart rate (beats per minute) during the induction and maintenance phases

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Heart Rate Induction phase - Day 0	74.7 beats per minute Standard Deviation 13.6	77.4 beats per minute Standard Deviation 12.3	73.6 beats per minute Standard Deviation 8.9	73.5 beats per minute Standard Deviation 9.0	—	—	—
Safety: Heart Rate Induction phase - Week 10	76.1 beats per minute Standard Deviation 13.9	74.1 beats per minute Standard Deviation 10.4	73.6 beats per minute Standard Deviation 9.0	73.9 beats per minute Standard Deviation 10.8	—	—	—
Safety: Heart Rate Induction phase - Week 22	69.6 beats per minute Standard Deviation 13.0	71.9 beats per minute Standard Deviation 9.1	71.6 beats per minute Standard Deviation 6.2	70.8 beats per minute Standard Deviation 7.1	—	—	—
Safety: Heart Rate Maintenance phase -Baseline	—	—	—	—	73.0 beats per minute Standard Deviation 9.2	73.4 beats per minute Standard Deviation 7.5	72.4 beats per minute Standard Deviation 9.7
Safety: Heart Rate Maintenance phase - Week 50	—	—	—	—	73.0 beats per minute Standard Deviation 8.6	73.2 beats per minute Standard Deviation 6.5	75.4 beats per minute Standard Deviation 10.7

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Number of patients with clinically significant changes in ECG

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: 12-lead Electrocardiogram (ECG)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to Week 50

Population: SAF

Number of participants with abnormal hematology laboratory values (treatment-emergent adverse events [TEAEs] related to hematological abnormalities)

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Hematology Anemia	3 Participants	6 Participants	4 Participants	3 Participants	1 Participants	2 Participants	2 Participants
Safety: Hematology Leukopenia	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Hematology Neutropenia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Hematology Thrombocytosis	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Safety: Hematology Hemoglobin decreased	0 Participants	2 Participants	9 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Safety: Hematology Platelet count increased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Hematology Leukocytosis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Safety: Hematology Microcytic anemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Safety: Hematology Neutrophil count increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Safety: Hematology White blood cell count increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Number of participants with abnormal blood chemistry laboratory values (TEAES related to clinical chemistry abnormalities)

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Blood Chemistry C-reactive protein increased	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Fecal calprotectin increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Hyperlipasemia	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Hypertriglyceridemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Hyperuricemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Hypokalemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Hypophosphatasemia	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Safety: Blood Chemistry Liver function test abnormal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Alanine transferase increased	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Amylase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Aspartate aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Safety: Blood Chemistry Blood bilirubin increased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Blood bilirubin unconjugated increased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Blood calcium decreased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Blood cholesterol increased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Blood creatinine increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Safety: Blood Chemistry Blood creatine phosphokinase MB increased	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Blood creatine phosphokinase increased	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Safety: Blood Chemistry Blood potassium increased	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Blood triglycerides increased	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Gamma-glutamyltransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Safety: Blood Chemistry Hepatic enzyme increased	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Safety: Blood Chemistry Hyperbilirubinemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Hyperkalemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Blood Chemistry Lipase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: SAF, Coagulation parameters were only analyzed in the Induction phase.

Number of participants with clinically significant abnormal coagulation laboratory values

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Safety: Coagulation	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: SAF

Number of participants with abnormal urinalysis laboratory values (TEAEs related to urinalysis)

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=45 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 Participants Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) n=27 Participants Two tablets once daily for up to 40 weeks
Safety: Urinalysis Crystalluria	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Hyperuricosuria	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Proteinuria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Safety: Urinalysis Blood urine present	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Safety: Urinalysis Creatinine urine increased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Hematuria	0 Participants	0 Participants	5 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Safety: Urinalysis Hemorrhage urinary tract	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Hyperoxaluria	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Ketonuria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Safety: Urinalysis Micturition urgency	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Red blood cells urine positive	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Safety: Urinalysis Renal colic	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety: Urinalysis Renal Cyst	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: SAF

Micro ribonucleic acid-122 (miR-122) expression (before first dose and 24 hours after first dose - foldchange of normalized expression values )

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=61 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=60 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=59 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=60 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Safety: Micro Ribonucleic Acid-122 Expression	2.0276 fold change Standard Deviation 2.7747	3.5573 fold change Standard Deviation 10.8852	1.8842 fold change Standard Deviation 3.5346	2.5739 fold change Standard Deviation 5.2723	—	—	—

SECONDARY outcome

Timeframe: Day 0, Day 1, Day 7, Week 2 and Week 10

Population: SAF

Measurement of pre-dose (trough) blood plasma levels of IMU-838 throughout the induction period

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=67 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=67 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=66 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Pharmacodynamics (PK): IMU-838 Trough Level Day 0	0.00 µg/mL Interval 0.0 to 0.0	0.00 µg/mL Interval 0.0 to 7.34	0.00 µg/mL Interval 0.0 to 0.0	—	—	—	—
Pharmacodynamics (PK): IMU-838 Trough Level Day 1	0.30 µg/mL Interval 0.0 to 1.74	0.94 µg/mL Interval 0.0 to 3.75	1.41 µg/mL Interval 0.0 to 5.63	—	—	—	—
Pharmacodynamics (PK): IMU-838 Trough Level Day 7	0.58 µg/mL Interval 0.0 to 2.13	1.71 µg/mL Interval 0.0 to 8.82	2.77 µg/mL Interval 0.7 to 8.29	—	—	—	—
Pharmacodynamics (PK): IMU-838 Trough Level Week 2	0.97 µg/mL Interval 0.0 to 3.0	3.24 µg/mL Interval 0.0 to 8.54	5.23 µg/mL Interval 1.3 to 11.0	—	—	—	—
Pharmacodynamics (PK): IMU-838 Trough Level Week 10	1.17 µg/mL Interval 0.0 to 3.43	3.32 µg/mL Interval 0.0 to 9.32	5.03 µg/mL Interval 0.93 to 11.8	—	—	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: SAF

Measurement of post-dose blood plasma levels of IMU-838 at Week 2

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=58 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=63 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=58 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
PK: IMU-838 Plasma Level	2.30 µg/mL Interval 0.0 to 4.23	6.05 µg/mL Interval 0.0 to 12.4	10.70 µg/mL Interval 1.68 to 23.4	—	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose

Population: No data were collected for this endpoint.

Single-dose PK measurement of AUC0-24h in a subset of patients in the open-label phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose

Population: No data were collected for this endpoint.

Single-dose PK measurement of AUC0-t in a subset of patients in the open-label phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose

Population: No data were collected for this endpoint.

Single-dose PK measurement of AUC0-inf in a subset of patients in the open-label phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose

Population: No data were collected for this endpoint.

Single-dose PK measurement of Cmax in a subset of patients in the open-label phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose

Population: No data were collected for this endpoint.

Single-dose PK measurement of Tmax in a subset of patients in the open-label phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 14, Week 30, Week 50

Population: FAS

Proportion of patients in symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) by visit up to Week 50 in maintenance phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=45 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=40 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=27 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Proportion of Patients in Symptomatic Remission Week 14	16 Participants	14 Participants	7 Participants	—	—	—	—
Maintenance Phase: Proportion of Patients in Symptomatic Remission Week 30	33 Participants	23 Participants	19 Participants	—	—	—	—
Maintenance Phase: Proportion of Patients in Symptomatic Remission Week 50	27 Participants	24 Participants	16 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Time course of Mayo PRO-2 score until Week 50. Mayo patient-reported outcome score, ie, stool frequency and rectal bleeding score each rated from 0 to 3 3 that are added up to give a total score that ranges from 0 to 6. A higher score indicates a worse outcome.

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=45 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=40 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=27 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Mayo PRO-2 Score Change from Baseline to Week 50	0.1 score on a scale Standard Deviation 0.9	0.2 score on a scale Standard Deviation 1.1	0.4 score on a scale Standard Deviation 0.9	—	—	—	—
Maintenance Phase: Mayo PRO-2 Score Maintenance phase Baseline	0.8 score on a scale Standard Deviation 0.5	0.9 score on a scale Standard Deviation 0.8	0.7 score on a scale Standard Deviation 0.5	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Time to symptomatic ulcerative colitis (UC) relapse

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=45 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=40 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=27 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Time to Relapse	231.7 days Standard Error 10	221.9 days Standard Error 16.2	186.6 days Standard Error 10.2	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Proportion of patients without symptomatic UC relapse until Week 50

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=43 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=36 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=26 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Proportion of Patients Without Relapse	32 Participants	24 Participants	18 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Timecourse of biomarker fCP in stool samples

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=45 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=40 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=27 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: fCP Maintenance phase Baseline	256.5 mg/kg Interval 3.0 to 1948.0	207.0 mg/kg Interval 3.0 to 16359.0	335.0 mg/kg Interval 9.0 to 4183.0	—	—	—	—
Maintenance Phase: fCP Week 14	99.0 mg/kg Interval 16.0 to 611.0	145.0 mg/kg Interval 12.0 to 2386.0	353.0 mg/kg Interval 19.0 to 2529.0	—	—	—	—
Maintenance Phase: fCP Week 30	149.0 mg/kg Interval 3.0 to 3169.0	217.0 mg/kg Interval 22.0 to 2431.0	210.0 mg/kg Interval 2.0 to 1694.0	—	—	—	—
Maintenance Phase: fCP Week 50	181.0 mg/kg Interval 11.0 to 1931.0	147.0 mg/kg Interval 27.0 to 5777.0	364.0 mg/kg Interval 18.0 to 1617.0	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Timecourse of biomarker CRP in blood samples

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=45 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=40 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=27 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: CRP Week 50	1.10 mg/L Interval 0.3 to 12.2	3.60 mg/L Interval 0.3 to 56.0	1.95 mg/L Interval 0.3 to 18.6	—	—	—	—
Maintenance Phase: CRP Maintenance phase Baseline	1.30 mg/L Interval 0.3 to 105.7	2.50 mg/L Interval 0.3 to 38.2	1.10 mg/L Interval 0.3 to 5.2	—	—	—	—
Maintenance Phase: CRP Week 14	1.10 mg/L Interval 0.3 to 19.2	1.50 mg/L Interval 0.3 to 23.4	1.90 mg/L Interval 0.3 to 7.6	—	—	—	—
Maintenance Phase: CRP Week 30	1.30 mg/L Interval 0.3 to 48.3	2.05 mg/L Interval 0.3 to 172.3	1.00 mg/L Interval 0.3 to 21.0	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Proportion of patients with endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 50 of maintenance phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=28 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=26 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=17 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Proportion of Patients With Endoscopic Healing	15 Participants	19 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Proportion of patients with microscopic healing (Geboes score of =< 3.1) at Week 50 of maintenance phase

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=30 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=26 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=17 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Proportion of Patients With Microscopic Healing	25 Participants	20 Participants	12 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 50 weeks

Population: FAS

Corticosteroid-free clinical remission (clinical remission and no receipt of systemic or local corticosteroids) at Week 50 in patients receiving corticosteroids at Baseline

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=26 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) n=26 Participants Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) n=18 Participants Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Maintenance Phase: Corticosteroid-free Remission	10 Participants	16 Participants	5 Participants	—	—	—	—

SECONDARY outcome

Timeframe: up to 4 years

Population: FAS

Proportion of patients with symptom control

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=190 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Open-label Phase: Symptom Control	55 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 OLE, Week 8 OLE, EoT up to 4 years (variable)

Population: FAS, separated by entry in OLE, data only shown if number of patients included in analysis ≥ 5 per visit

Timecourse of biomarker fCP in stool samples. Visits were scheduled every 4 weeks (+/-7 days) until 50 weeks of total study participation (ie induction + extended induction, if applicable, maintenance + open-label part) and every 10 weeks (+/-7 days) thereafter. The visit schedule in the OLE after 50 weeks of overall study treatment was changed from a 10-week schedule to a 24 week (+/-14 days) schedule after Protocol Version 6.0 came into force.

Because the study was terminated early, EoT varied between patients depending on when patients entered the study and the time a patient participated in the induction and maintenance phases before switching to the OLE.

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=190 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Open-label Phase: fCP Entry in OLE after maintenance phase - Baseline	221.0 mg/kg Interval 8.0 to 5777.0	—	—	—	—	—	—
Open-label Phase: fCP Entry in OLE after (extended) induction phase - Baseline	542.0 mg/kg Interval 6.0 to 19955.0	—	—	—	—	—	—
Open-label Phase: fCP Entry in OLE after (extended) induction phase - Visit 1 (Week 4 OLE)	557.0 mg/kg Interval 98.0 to 4774.0	—	—	—	—	—	—
Open-label Phase: fCP Entry in OLE after (extended) induction phase - Visit 2 (Week 8 OLE)	467.0 mg/kg Interval 55.0 to 2271.0	—	—	—	—	—	—
Open-label Phase: fCP Entry in OLE after (extended) induction phase - end of treatment (up to 4 years, variable)	234.0 mg/kg Interval 5.0 to 9906.0	—	—	—	—	—	—
Open-label Phase: fCP Entry in OLE after maintenance phase - end of treatment (up to 4 years, variable)	168.0 mg/kg Interval 3.0 to 5256.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 OLE, Week 8 OLE, Week 10 OLE, Week 12 OLE, Week 16 OLE, Week 20 OLE, Week 24 OLE, Week 28 OLE, Week 32 or 38 OLE (depending if entry was after extended induction phase), EoT up to 4 years (variable)

Population: FAS, separated by entry in OLE, data only shown if number of patients included in analysis ≥ 50 per visit

Timecourse of biomarker CRP in blood samples. Visits were scheduled every 4 weeks (+/-7 days) until 50 weeks of total study participation (ie induction + extended induction, if applicable, maintenance + open-label part) and every 10 weeks (+/-7 days) thereafter. The visit schedule in the OLE after 50 weeks of overall study treatment was changed from a 10-week schedule to a 24 week (+/-14 days) schedule after Protocol Version 6.0 came into force.

Because the study was terminated early, EoT varied between patients depending on when patients entered the study and the time a patient participated in the induction and maintenance phases before switching to the OLE.

Outcome measures

Measure	Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) n=190 Participants Two 15 or 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	Placebo (Induction Phase) Two tablets once daily for 10 to 22 weeks.	45 mg IMU-838 (Induction Phase) Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Maintenance Phase) Two 15 mg tablets once daily of IMU-838 for up to 40 weeks.	Placebo (Maintenance Phase) Two tablets once daily for up to 40 weeks
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 5 (Week 20 OLE)	3.60 mg/L Interval 0.3 to 46.1	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 7 (Week 28 OLE)	2.80 mg/L Interval 0.3 to 39.5	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after maintenance phase - Baseline	1.90 mg/L Interval 0.3 to 56.0	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 2 (Week 8 OLE)	2.30 mg/L Interval 0.3 to 71.9	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 3 (Week 12 OLE)	2.40 mg/L Interval 0.3 to 37.3	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 4 (Week 16 OLE)	2.60 mg/L Interval 0.3 to 178.9	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Baseline	5.20 mg/L Interval 0.3 to 69.9	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 1 (Week 4 OLE)	3.30 mg/L Interval 0.3 to 41.8	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 8 (Week 32 or 38 OLE)	2.20 mg/L Interval 0.3 to 49.9	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - end of treatment (up to 4 years, variable)	2.45 mg/L Interval 0.3 to 46.5	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after (extended) induction phase - Visit 6 (Week 24 OLE)	3.40 mg/L Interval 0.3 to 26.0	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after maintenance phase - Visit 1 (Week 10 OLE)	1.55 mg/L Interval 0.3 to 79.8	—	—	—	—	—	—
Open-label Phase: CRP Entry in OLE after maintenance phase - Visit 2 (Week 20 OLE)	1.25 mg/L Interval 0.3 to 16.3	—	—	—	—	—	—

Adverse Events

10 mg IMU-838 (Induction Phase)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

30 mg IMU-838 (Induction Phase)

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

45 mg IMU-838 (Induction Phase)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo (Induction Phase)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

10 mg IMU-838 (Maintenance Phase)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

30 mg IMU-838 (Maintenance Phase)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo (Maintenance Phase)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

30 mg IMU-838 (Open-label Phase)

Serious events: 14 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	10 mg IMU-838 (Induction Phase) n=67 participants at risk Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Induction Phase) n=67 participants at risk Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks. IMU-838: IMU-838 tablet	45 mg IMU-838 (Induction Phase) n=66 participants at risk Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks. IMU-838: IMU-838 tablet	Placebo (Induction Phase) n=63 participants at risk Two tablets once daily for 10 to 22 weeks.	10 mg IMU-838 (Maintenance Phase) n=45 participants at risk Two 5 mg tablets once daily of IMU-838 for up to 50 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 participants at risk Two 15 mg tablets once daily of IMU-838 for up to 50 weeks.	Placebo (Maintenance Phase) n=27 participants at risk Two tablets once daily for up to 50 weeks.	30 mg IMU-838 (Open-label Phase) n=190 participants at risk Two 15 mg tablets once daily of IMU-838.
Blood and lymphatic system disorders Anaemia	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.5% 1/40 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Diarrhea hemorrhagic	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.6% 3/190 • Number of events 4 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Haematochezia	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Inguinal hernia	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Large intestine perforation	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Proctitis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Umbilical hernia	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Volvulus	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Hepatobiliary disorders Cholecystitis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.2% 1/45 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Abscess limb	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations COVID-19	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations COVID-19 pneumonia	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Clostridium difficile infection	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.2% 1/45 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Colon gangrene	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Peritonitis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Pharyngitis streptococcal	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Pyelonephritis acute	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Sepsis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Urinary tract infection	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Injury, poisoning and procedural complications Femur fracture	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Injury, poisoning and procedural complications Skull fracture	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Injury, poisoning and procedural complications Spinal compression fracture	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Investigations Haemoglobin decreased	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Investigations Hepatic enzyme increased	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.5% 1/40 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Renal and urinary disorders Acute kidney injury	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Renal and urinary disorders Renal colic	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	3.7% 1/27 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Cardiac disorders Acute coronary syndrome	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.2% 1/45 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/190 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Cardiac disorders Coronary artery stenosis	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/63 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years

Other adverse events

Measure	10 mg IMU-838 (Induction Phase) n=67 participants at risk Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks.	30 mg IMU-838 (Induction Phase) n=67 participants at risk Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks. IMU-838: IMU-838 tablet	45 mg IMU-838 (Induction Phase) n=66 participants at risk Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks. IMU-838: IMU-838 tablet	Placebo (Induction Phase) n=63 participants at risk Two tablets once daily for 10 to 22 weeks.	10 mg IMU-838 (Maintenance Phase) n=45 participants at risk Two 5 mg tablets once daily of IMU-838 for up to 50 weeks.	30 mg IMU-838 (Maintenance Phase) n=40 participants at risk Two 15 mg tablets once daily of IMU-838 for up to 50 weeks.	Placebo (Maintenance Phase) n=27 participants at risk Two tablets once daily for up to 50 weeks.	30 mg IMU-838 (Open-label Phase) n=190 participants at risk Two 15 mg tablets once daily of IMU-838.
Blood and lymphatic system disorders Anaemia	3.0% 2/67 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	7.5% 5/67 • Number of events 5 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	4.5% 3/66 • Number of events 3 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	4.8% 3/63 • Number of events 3 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.2% 1/45 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.5% 1/40 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	7.4% 2/27 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.6% 5/190 • Number of events 6 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Gastrointestinal disorders Vomiting	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/66 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	4.8% 3/63 • Number of events 3 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/40 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.53% 1/190 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations COVID-19	3.0% 2/67 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	3.0% 2/66 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	3.2% 2/63 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	11.1% 5/45 • Number of events 5 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.5% 1/40 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	7.4% 14/190 • Number of events 14 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Infections and infestations Urinary tract infection	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.6% 1/63 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.2% 1/45 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	5.0% 2/40 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.6% 3/190 • Number of events 3 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Nervous system disorders Headache	4.5% 3/67 • Number of events 3 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/67 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.5% 1/66 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	6.3% 4/63 • Number of events 4 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.5% 1/40 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	2.6% 5/190 • Number of events 7 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years
Renal and urinary disorders Haematuria	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/67 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	7.6% 5/66 • Number of events 7 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.6% 1/63 • Number of events 1 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/45 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	5.0% 2/40 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	0.00% 0/27 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years	1.1% 2/190 • Number of events 2 • Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years

Additional Information

Andreas Muehler, MD

Immunic AG

Phone: 004989

Email: Andreas.Muehler@imux.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60