A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03123120
• Collaborator: (none)
• Enrollment: 22
• Locations: 16
• Arms: 2
• Actual Duration (Months): 39.3
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.

This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Spesolimab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy
• Actual Study Start Date: Jun 7, 2017
• Actual Primary Completion Date: Mar 26, 2020
• Actual Study Completion Date: Sep 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spesolimab 1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).	Drug: Spesolimab; 12 weeks treatment; Other Names: BI 655130
Placebo Comparator: Placebo Matching placebo was administered via intravenous infusion over 12 weeks of treatment.	Drug: Placebo; 12 weeks treatment

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 [At Week 12]

   Proportion of participants with endoscopic improvement (Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤1) at Week 12 was reported. The endoscopic improvement (mucosal healing) was defined as the Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤ 1 point. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The mESS was assessed by a central reader who was independent from the investigator. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.

Secondary Outcome Measures

1. Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 [At Week 12]

   Proportion of participants with total clinical remission based on total Mayo clinical score at Week 12 was reported. The total clinical remission based on total Mayo clinical score was defined as the total Mayo clinical score ≤ 2 points and all sub-scores ≤ 1 point. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.

2. Proportion of Participants With Histological Remission at Week 12 [At Week 12]

   Proportion of participants with histological remission at Week 12 was reported. The histological remission was defined as the Robarts histology index score ≤ 6. The Robarts histopathology index (RHI) was a histologic activity score, scoring the components chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium and erosion or ulceration on a scale of 0 to 3. The 4 components were weighted differently to calculate the RHI, with RHI = 1 × chronic inflammatory infiltrate level + 2 × lamina propria neutrophils + 3 × neutrophils in epithelium + 5 × erosion or ulceration. The resulting RHI score ranged from 0 (no disease activity) to 33 (severe disease activity). The 95% confidence intervals (in descriptive statistics part) were calculated using the method of Wilson.

3. Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 [At Week 12]

   Proportion of participants with clinical remission (CR) based on Mayo clinical score at Week 12 was reported. The clinical remission based on Mayo clinical score was defined as the total Mayo clinical Score ≤ 2 and Rectal Bleeding Subscore = 0, Stool Frequency Score =0 or 1 and drop ≥ 1 from baseline, and Modified endoscopic sub-score (mESS) ≤ 1. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo clinical score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.

4. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [From first does of study medication until end of the follow-up period, up to 36 weeks.]

   Number of participants with any treatment-emergent adverse events (TEAEs) was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• 18 - 75 years at screening and randomisation

• Diagnosis of ulcerative colitis >= 5 months prior to screening

• Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4 months (Infliximab) or >= 2 Monaten (Adalimumab or Golimumab) prior to randomisation

• Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10)

• Further inclusion criteria apply

Exclusion Criteria:

• Prior use of more than two different TNF inhibitors or vedolizumab

• Extensive colonic resection

• Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening

• Active or latent tuberculosis

• Further exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg Sygehus Syd	Aalborg		Denmark	9100
2	Sanos Clinic	Herlev		Denmark	2730
3	Odense University Hospital	Odense		Denmark	5000
4	Universitätsklinikum Erlangen	Erlangen		Germany	91054
5	Universitätsklinikum Freiburg	Freiburg		Germany	79106
6	Medizinische Hochschule Hannover	Hannover		Germany	30625
7	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel		Germany	24105
8	Universitätsklinikum Ulm	Ulm		Germany	89081
9	Amsterdam UMC, Locatie AMC	Amsterdam		Netherlands	1105 AZ
10	Akershus Universitetssykehus HF	Lørenskog		Norway	N-1478
11	Hospital Puerta de Hierro	Majadahonda		Spain	28222
12	Hospital Universitario Marqués de Valdecilla	Santander		Spain	39008
13	Hospital Politècnic La Fe	Valencia		Spain	46026
14	St James's University Hospital	Leeds		United Kingdom	LS9 7TF
15	Guy's Hospital	London		United Kingdom	SE1 9RT
16	Whiston Hospital	Prescot		United Kingdom	L35 5DR

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 4, 2019
• Statistical Analysis Plan - Mar 4, 2020

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03123120
• Other Study ID Numbers: 1368-0010; 2016-004572-21
• First Posted: Apr 21, 2017
• Last Update Posted: Nov 9, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

Participant Flow

Recruitment Details	This randomized, placebo-controlled, double-blind, parallel-group trial over 36 weeks, including a 24-week follow-up period evaluated safety and efficacy of induction of mucosal healing by Spesolimab (BI 655130) add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing tumor necrosis factor inhibitor treatment.
Pre-assignment Detail	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.

Arm/Group Title	Placebo - Randomized	Spesolimab 1200 mg - Randomized
Arm/Group Description	Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.
Period Title: Overall Study
STARTED	8	14
Safety Analysis Set (SAF)	7	15
COMPLETED	8	12
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Placebo - Randomized	Spesolimab 1200 mg - Randomized	Total
Arm/Group Description	Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.	Total of all reporting groups
Overall Participants	8	14	22
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.5 (12.1)	43.1 (9.9)	44.0 (10.5)
Sex: Female, Male (Count of Participants)
Female	1 12.5%	4 28.6%	5 22.7%
Male	7 87.5%	10 71.4%	17 77.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	8 100%	14 100%	22 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	8 100%	13 92.9%	21 95.5%
More than one race	0 0%	1 7.1%	1 4.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Mayo clinical score (MCS) modified endoscopic subscore (mESS) (Score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on a scale]	2.8 (0.5)	2.8 (0.4)	2.8 (0.4)
Number of participants per Mayo clinical score modified endoscopic subscore value group (Count of Participants)
0	0 0%	0 0%	0 0%
1	0 0%	0 0%	0 0%
2	2 25%	3 21.4%	5 22.7%
3	6 75%	11 78.6%	17 77.3%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12
Description	Proportion of participants with endoscopic improvement (Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤1) at Week 12 was reported. The endoscopic improvement (mucosal healing) was defined as the Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤ 1 point. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The mESS was assessed by a central reader who was independent from the investigator. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.
Time Frame	At Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS.

Arm/Group Title	Placebo - Randomized	Spesolimab 1200 mg - Randomized
Arm/Group Description	Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.
Measure Participants	8	14
Number (95% Confidence Interval) [Proportion of participants]	0.375 4.7%	0.143 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo - Randomized, Spesolimab 1200 mg - Randomized
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.232
	Confidence Interval	(2-Sided) 95%; -0.568 to 0.118
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.

2. Secondary Outcome

Title	Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12
Description	Proportion of participants with total clinical remission based on total Mayo clinical score at Week 12 was reported. The total clinical remission based on total Mayo clinical score was defined as the total Mayo clinical score ≤ 2 points and all sub-scores ≤ 1 point. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.
Time Frame	At Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS.

Arm/Group Title	Placebo - Randomized	Spesolimab 1200 mg - Randomized
Arm/Group Description	Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.
Measure Participants	8	14
Number (95% Confidence Interval) [Proportion of participants]	0.125 1.6%	0.071 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo - Randomized, Spesolimab 1200 mg - Randomized
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.054
	Confidence Interval	(2-Sided) 95%; -0.404 to 0.210
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.

3. Secondary Outcome

Title	Proportion of Participants With Histological Remission at Week 12
Description	Proportion of participants with histological remission at Week 12 was reported. The histological remission was defined as the Robarts histology index score ≤ 6. The Robarts histopathology index (RHI) was a histologic activity score, scoring the components chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium and erosion or ulceration on a scale of 0 to 3. The 4 components were weighted differently to calculate the RHI, with RHI = 1 × chronic inflammatory infiltrate level + 2 × lamina propria neutrophils + 3 × neutrophils in epithelium + 5 × erosion or ulceration. The resulting RHI score ranged from 0 (no disease activity) to 33 (severe disease activity). The 95% confidence intervals (in descriptive statistics part) were calculated using the method of Wilson.
Time Frame	At Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS.

Arm/Group Title	Placebo - Randomized	Spesolimab 1200 mg - Randomized
Arm/Group Description	Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.
Measure Participants	8	14
Number (95% Confidence Interval) [Proportion of participants]	0.500 6.3%	0.214 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo - Randomized, Spesolimab 1200 mg - Randomized
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.286
	Confidence Interval	(2-Sided) 95%; -0.602 to 0.101
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.

4. Secondary Outcome

Title	Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12
Description	Proportion of participants with clinical remission (CR) based on Mayo clinical score at Week 12 was reported. The clinical remission based on Mayo clinical score was defined as the total Mayo clinical Score ≤ 2 and Rectal Bleeding Subscore = 0, Stool Frequency Score =0 or 1 and drop ≥ 1 from baseline, and Modified endoscopic sub-score (mESS) ≤ 1. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo clinical score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.
Time Frame	At Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS.

Arm/Group Title	Placebo - Randomized	Spesolimab 1200 mg - Randomized
Arm/Group Description	Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.
Measure Participants	8	14
Number (95% Confidence Interval) [Proportion of participants]	0.000 0%	0.143 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo - Randomized, Spesolimab 1200 mg - Randomized
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.143
	Confidence Interval	(2-Sided) 95%; -0.197 to 0.399
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.

5. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	Number of participants with any treatment-emergent adverse events (TEAEs) was reported.
Time Frame	From first does of study medication until end of the follow-up period, up to 36 weeks.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (SAF): this patient set included all randomized patients who received at least one dose of trial drug. Treatment assignment was analyzed according to the actual treatment. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group in the SAF.

Arm/Group Title	Placebo - Actual	Spesolimab 1200 mg - Actual
Arm/Group Description	Matching placebo were administered via intravenous over 12 weeks of treatment. Participants who actually administered placebo during the study were included in this group. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group.	1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment. Participants who actually administered Spesolimab during the study were included in this group. 1 patient who was assigned to Placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group.
Measure Participants	7	15
Count of Participants [Participants]	6 75%	15 107.1%

Adverse Events

Time Frame	From first does of study medication until end of the follow-up period, up to 36 weeks.
Adverse Event Reporting Description	Safety Analysis Set (SAF): this patient set included all randomized patients who received at least one dose of trial drug. Treatment assignment was analyzed according to the actual treatment. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group in the SAF.
Arm/Group Title	Placebo - Actual		Spesolimab 1200 mg - Actual
Arm/Group Description	Matching placebo were administered via intravenous over 12 weeks of treatment. Participants who actually administered placebo during the study were included in this group. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group.		1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment. Participants who actually administered Spesolimab during the study were included in this group. 1 patient who was assigned to Placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group.
All Cause Mortality
	Placebo - Actual		Spesolimab 1200 mg - Actual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/15 (0%)
Serious Adverse Events
	Placebo - Actual		Spesolimab 1200 mg - Actual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		2/15 (13.3%)
Gastrointestinal disorders
Colitis ulcerative	1/7 (14.3%)		1/15 (6.7%)
Infections and infestations
Rectal abscess	1/7 (14.3%)		0/15 (0%)
Injury, poisoning and procedural complications
Gastrointestinal stoma complication	0/7 (0%)		1/15 (6.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	0/7 (0%)		1/15 (6.7%)
Other (Not Including Serious) Adverse Events
	Placebo - Actual		Spesolimab 1200 mg - Actual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		15/15 (100%)
Blood and lymphatic system disorders
Anaemia	0/7 (0%)		2/15 (13.3%)
Lymphadenopathy	0/7 (0%)		1/15 (6.7%)
Neutropenia	0/7 (0%)		1/15 (6.7%)
Eye disorders
Episcleritis	0/7 (0%)		1/15 (6.7%)
Ocular discomfort	0/7 (0%)		1/15 (6.7%)
Gastrointestinal disorders
Abdominal pain	0/7 (0%)		1/15 (6.7%)
Colitis ulcerative	2/7 (28.6%)		3/15 (20%)
Diarrhoea	0/7 (0%)		1/15 (6.7%)
Dyspepsia	0/7 (0%)		1/15 (6.7%)
Haemorrhoids	0/7 (0%)		1/15 (6.7%)
Nausea	0/7 (0%)		2/15 (13.3%)
General disorders
Influenza like illness	0/7 (0%)		2/15 (13.3%)
Malaise	0/7 (0%)		1/15 (6.7%)
Infections and infestations
Cystitis	0/7 (0%)		1/15 (6.7%)
Gastroenteritis	0/7 (0%)		2/15 (13.3%)
Helicobacter gastritis	0/7 (0%)		1/15 (6.7%)
Nasopharyngitis	2/7 (28.6%)		5/15 (33.3%)
Upper respiratory tract infection	0/7 (0%)		1/15 (6.7%)
Viral upper respiratory tract infection	0/7 (0%)		1/15 (6.7%)
Injury, poisoning and procedural complications
Contusion	1/7 (14.3%)		0/15 (0%)
Metabolism and nutrition disorders
Iron deficiency	0/7 (0%)		1/15 (6.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/7 (0%)		2/15 (13.3%)
Back pain	1/7 (14.3%)		0/15 (0%)
Foot deformity	0/7 (0%)		1/15 (6.7%)
Joint swelling	0/7 (0%)		1/15 (6.7%)
Muscle spasms	0/7 (0%)		1/15 (6.7%)
Nervous system disorders
Headache	1/7 (14.3%)		4/15 (26.7%)
Migraine	0/7 (0%)		1/15 (6.7%)
Paraesthesia	0/7 (0%)		1/15 (6.7%)
Presyncope	0/7 (0%)		1/15 (6.7%)
Psychiatric disorders
Adjustment disorder	0/7 (0%)		1/15 (6.7%)
Respiratory, thoracic and mediastinal disorders
Sputum increased	1/7 (14.3%)		0/15 (0%)
Skin and subcutaneous tissue disorders
Acne	0/7 (0%)		2/15 (13.3%)
Alopecia	0/7 (0%)		1/15 (6.7%)
Eczema	0/7 (0%)		2/15 (13.3%)
Pruritus	1/7 (14.3%)		0/15 (0%)
Rash	1/7 (14.3%)		0/15 (0%)
Stasis dermatitis	1/7 (14.3%)		0/15 (0%)
Vascular disorders
Hypertension	0/7 (0%)		1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.