Trial Outcomes & Findings for 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 (NCT NCT03123120)

Last Updated: 2025-10-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

At Week 12

Results posted on

2025-10-16

Participant Flow

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.

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	Placebo - Randomized 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.	Spesolimab 1200 mg - Randomized 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.
Overall Study STARTED	8	14
Overall Study Safety Analysis Set (SAF)	7	15
Overall Study COMPLETED	8	12
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo - Randomized 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.	Spesolimab 1200 mg - Randomized 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.
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo - Randomized n=8 Participants 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.	Spesolimab 1200 mg - Randomized n=14 Participants 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.
Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12	0.375 Proportion of participants Interval 0.137 to 0.694	0.143 Proportion of participants Interval 0.04 to 0.399

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo - Randomized n=8 Participants 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.	Spesolimab 1200 mg - Randomized n=14 Participants 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.
Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12	0.125 Proportion of participants Interval 0.022 to 0.471	0.071 Proportion of participants Interval 0.013 to 0.315

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo - Randomized n=8 Participants 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.	Spesolimab 1200 mg - Randomized n=14 Participants 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.
Proportion of Participants With Histological Remission at Week 12	0.500 Proportion of participants Interval 0.215 to 0.785	0.214 Proportion of participants Interval 0.076 to 0.476

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo - Randomized n=8 Participants 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.	Spesolimab 1200 mg - Randomized n=14 Participants 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.
Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12	0.000 Proportion of participants Interval 0.0 to 0.324	0.143 Proportion of participants Interval 0.04 to 0.399

SECONDARY outcome

Timeframe: From first does of study medication until end of the follow-up period, up to 36 weeks.

Population: 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.

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

Outcome measures

Outcome measures
Measure	Placebo - Randomized n=7 Participants 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.	Spesolimab 1200 mg - Randomized n=15 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	6 Participants	15 Participants

Adverse Events

Placebo - Actual

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Spesolimab 1200 mg - Actual

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Actual n=7 participants at risk 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.	Spesolimab 1200 mg - Actual n=15 participants at risk 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.
Gastrointestinal disorders Colitis ulcerative	14.3% 1/7 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.	6.7% 1/15 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.
Infections and infestations Rectal abscess	14.3% 1/7 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.	0.00% 0/15 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/7 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.	6.7% 1/15 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/7 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.	6.7% 1/15 • From first does of study medication until end of the follow-up period, up to 36 weeks. 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.

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Placebo - Randomized n=8 Participants 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.	Spesolimab 1200 mg - Randomized n=14 Participants 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 n=22 Participants Total of all reporting groups
Age, Continuous	45.5 Years STANDARD_DEVIATION 12.1 • n=5 Participants	43.1 Years STANDARD_DEVIATION 9.9 • n=7 Participants	44.0 Years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Mayo clinical score (MCS) modified endoscopic subscore (mESS)	2.8 Score on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	2.8 Score on a scale STANDARD_DEVIATION 0.4 • n=7 Participants	2.8 Score on a scale STANDARD_DEVIATION 0.4 • n=5 Participants
Number of participants per Mayo clinical score modified endoscopic subscore value group 0	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Number of participants per Mayo clinical score modified endoscopic subscore value group 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Number of participants per Mayo clinical score modified endoscopic subscore value group 2	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Number of participants per Mayo clinical score modified endoscopic subscore value group 3	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants