Trial Outcomes & Findings for A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease (NCT NCT03752970)

Last Updated: 2025-10-16

Results Overview

The total number of deregulated genes based on biopsies from the inner fistula orifice at Week 4 comparing changes in gene expression from baseline between the two treatment groups. For each gene, a repeated measures linear regression model was utilized with treatment (BI 655130 or Placebo), visit (baseline, week 4), treatment by visit interaction as fixed effect and patient as a blocking factor. Changes will be quantified by log2 fold changes (FC) and associated False Discovery Rate (FDR) adjusted p-values. Genes will be considered deregulated if they fulfil the following criteria: * FDR adjusted p-value ≤ 0.05 * \|fold change\| ≥ 1.5 (\|log2 fold change\| ≥ 0.58)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Biopsies taken at screening (Week -3) and at week 4 of treatment.

Results posted on

2025-10-16

Participant Flow

The trial was divided into a Screening Cohort and a Study Cohort: Screening Cohort did not receive study treatment. Study Cohort was a randomised, double-blind, placebo-controlled, Phase IIa design, and was conducted in 2 periods each of 12 weeks' duration. Patients who completed Week 24 of Period 2 and had clinical benefit were offered continued treatment in an open label, long-term extension study. Patients who did not continue into the extension study were followed up at Week 36.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Screening Cohort Patients enrolled in the Screening Cohort did not receive study treatment. This was a feasibility phase for fistula preparation and seton placement to determine the tissue samples that were suitable for analysis of the primary endpoint in the Study Cohort.	Study Cohort - Placebo Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
Screening Cohort STARTED	6	0	0
Screening Cohort COMPLETED	6	0	0
Screening Cohort NOT COMPLETED	0	0	0
Study Cohort Period 1 (Week 1 - <week12) STARTED	0	10	11
Study Cohort Period 1 (Week 1 - <week12) COMPLETED	0	9	9
Study Cohort Period 1 (Week 1 - <week12) NOT COMPLETED	0	1	2
Study Cohort Week 12 Assignment STARTED	0	9	9
Study Cohort Week 12 Assignment Switching Patients	0	4	0
Study Cohort Week 12 Assignment COMPLETED	0	5	9
Study Cohort Week 12 Assignment NOT COMPLETED	0	4	0
Study Cohort - Period 2 (>=Week 12 - 24) STARTED	0	5	13
Study Cohort - Period 2 (>=Week 12 - 24) COMPLETED	0	5	12
Study Cohort - Period 2 (>=Week 12 - 24) NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Cohort - Placebo Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
Study Cohort Period 1 (Week 1 - <week12) Lack of Efficacy	1	0
Study Cohort Period 1 (Week 1 - <week12) Lost to Follow-up	0	1
Study Cohort Period 1 (Week 1 - <week12) Withdrawal by Subject	0	1
Study Cohort Week 12 Assignment Switched to Spesolimab in period 2	4	0
Study Cohort - Period 2 (>=Week 12 - 24) Withdrawal by Subject	0	1

Baseline Characteristics

A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening Cohort n=6 Participants Patients enrolled in the Screening Cohort did not receive study treatment. This was a feasibility phase for fistula preparation and seton placement to determine the tissue samples that were suitable for analysis of the primary endpoint in the Study Cohort.	Study Cohort - Placebo n=10 Participants Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab n=11 Participants Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).	Total n=27 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 10.8 • n=5 Participants	34.0 years STANDARD_DEVIATION 8.3 • n=7 Participants	39.2 years STANDARD_DEVIATION 10.8 • n=5 Participants	38.0 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Biopsies taken at screening (Week -3) and at week 4 of treatment.

Population: RNA Sequencing Set: All patients who were randomised and treated with any amount of study drug and who provide a valid baseline and at least one valid post-baseline observation for at least one gene expression variable of biopsy. Data analysed with original results (OR) approach, implying the presentation of data exactly as observed.

Outcome measures

Outcome measures
Measure	Study Cohort - Placebo n=9 Participants Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab n=7 Participants Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
The Total Number of Deregulated Genes at Week 4	0 Deregulated genes	0 Deregulated genes

SECONDARY outcome

Timeframe: At baseline (day 1) and week 12 (day 85) of treatment.

Population: Includes all patients of the Study Cohort who provided a baseline value and at least one post-baseline value for at least one secondary endpoint or further efficacy endpoint. Following the intent-to-treat principle, patients will be analysed according to the treatment they were assigned to at randomisation.

Number of patients with perianal fistula response at Week 12 defined as closure of at least 50% of external openings, no drainage/discharge despite gentle finger compression of fistulas that were draining at baseline and without new emerging fistulas. The no response imputation (NRI) approach is applied: missing visits where imputed whereby all subsequent visits after a patient took rescue medication for the disease under study or died due to any cause were considered to be missing.

Outcome measures

Outcome measures
Measure	Study Cohort - Placebo n=10 Participants Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab n=11 Participants Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
Number of Patients With Perianal Fistula Response at Week 12	7 Participants	1 Participants

SECONDARY outcome

Timeframe: At baseline (day 1) and week 12 (day 85) of treatment.

Proportion of patients with perianal fistula remission at Week 12 defined as closure of all external openings, no drainage/discharge despite gentle finger compression of fistulas that were draining at baseline and without new emerging fistulas. The no response imputation (NRI) approach is applied: missing visits where imputed whereby all subsequent visits after a patient took rescue medication for the disease under study or died due to any cause were considered to be missing.

Outcome measures

Outcome measures
Measure	Study Cohort - Placebo n=10 Participants Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab n=11 Participants Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
Number of Patients With Perianal Fistula Remission at Week 12	6 Participants	1 Participants

SECONDARY outcome

Timeframe: At baseline (day 1) and week 12 (day 85) of treatment.

Number of patients with combined perianal fistula remission at Week 12 defined as closure of all external openings, no drainage/discharge despite gentle finger compression of fistulas that were draining at baseline and without new emerging fistulas, AND absence collections of \>2 centimeter, confirmed by magnetic resonance imaging (MRI) in at least 2 of 3 dimensions - blinded and centrally read. The no response imputation (NRI) approach is applied: missing visits where imputed whereby all subsequent visits after a patient took rescue medication for the disease under study or died due to any cause were considered to be missing.

Outcome measures

Outcome measures
Measure	Study Cohort - Placebo n=10 Participants Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).	Study Cohort - Spesolimab n=11 Participants Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
Number of Patients With Combined Perianal Fistula Remission at Week 12	6 Participants	1 Participants

Adverse Events

Screening Cohort

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Cohort Period 1: Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Study Cohort Period 1: Spesolimab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Study Cohort Period 2: Placebo - Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Study Cohort Period 2: Placebo - Spesolimab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Study Cohort Period 2: Spesolimab - Spesolimab

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Screening Cohort n=6 participants at risk Patients enrolled in the Screening Cohort did not receive study treatment. This was a feasibility phase for fistula preparation and seton placement to determine the tissue samples that were suitable for analysis of the primary endpoint in the Study Cohort.	Study Cohort Period 1: Placebo n=10 participants at risk Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). The arm only considers adverse events reported in period 1.	Study Cohort Period 1: Spesolimab n=11 participants at risk Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8). The arm only considers adverse events reported in period 1.	Study Cohort Period 2: Placebo - Placebo n=5 participants at risk Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). The arm only considers adverse events reported in period 2.	Study Cohort Period 2: Placebo - Spesolimab n=4 participants at risk Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). The arm only considers adverse events reported in period 2.	Study Cohort Period 2: Spesolimab - Spesolimab n=9 participants at risk Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). The arm only considers adverse events reported in period 2.
Gastrointestinal disorders Proctalgia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Peritonsillar abscess	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.

Other adverse events

Other adverse events
Measure	Screening Cohort n=6 participants at risk Patients enrolled in the Screening Cohort did not receive study treatment. This was a feasibility phase for fistula preparation and seton placement to determine the tissue samples that were suitable for analysis of the primary endpoint in the Study Cohort.	Study Cohort Period 1: Placebo n=10 participants at risk Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). The arm only considers adverse events reported in period 1.	Study Cohort Period 1: Spesolimab n=11 participants at risk Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8). The arm only considers adverse events reported in period 1.	Study Cohort Period 2: Placebo - Placebo n=5 participants at risk Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). The arm only considers adverse events reported in period 2.	Study Cohort Period 2: Placebo - Spesolimab n=4 participants at risk Patients with perianal fistulising Crohn's disease received Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). The arm only considers adverse events reported in period 2.	Study Cohort Period 2: Spesolimab - Spesolimab n=9 participants at risk Patients with perianal fistulising Crohn's disease received Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). The arm only considers adverse events reported in period 2.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Endocrine disorders Goitre	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Eye disorders Ocular hyperaemia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Gastrointestinal disorders Anal fissure	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Gastrointestinal disorders Anal fistula	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Gastrointestinal disorders Crohn's disease	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
General disorders Enanthema	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
General disorders Influenza like illness	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
General disorders Pain	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
General disorders Pyrexia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Abscess limb	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Anal abscess	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Asymptomatic COVID-19	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Bronchitis	16.7% 1/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations COVID-19	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	50.0% 2/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Influenza	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	11.1% 1/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Latent tuberculosis	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	11.1% 1/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 2/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	27.3% 3/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	11.1% 1/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Infections and infestations Rhinitis	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	11.1% 1/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 2/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	20.0% 1/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	11.1% 1/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	9.1% 1/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Nervous system disorders Headache	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	11.1% 1/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	25.0% 1/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.
Vascular disorders Raynaud's phenomenon	0.00% 0/6 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	10.0% 1/10 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/11 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/5 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/4 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.	0.00% 0/9 • Screening cohort: up to 56 days. Period 1: From start of treatment (Placebo or Spesolimab) in period 1 till start of treatment (Placebo or Spesolimab) in period 2, up to 84 days. Period 2: From start of treatment (Placebo or Spesolimab) in period 2 till end of last infusion (Placebo or Spesolimab) in period 2 + residual effect period of 112 days, up to 182 days. Screening cohort: all patients of the Screening Cohort who entered the trial. Study cohort: all patients who were randomised and treated with any amount of study drug.

Additional Information

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Boehringer Ingelheim

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