Trial · NCT03123120
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
NCT03123120, Phase 2, Completed, Boehringer Ingelheim; results first posted 2021-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03123120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03123120
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT03123120
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Colitis, Ulcerative
- Interventions
- Spesolimab, Placebo
- First posted
- 2017-04-21
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2016-004572-21
- Results first posted
- 2021-10-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 | At Week 12 | 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. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 | At Week 12 | 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. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Histological Remission at Week 12 | At Week 12 | 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. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 | At Week 12 | 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. | Proportion of participants | NUMBER |
| SECONDARY | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 | Placebo - Randomized | 0.375 | 95% Confidence Interval 0.137 to 0.694 | Proportion of participants | |
| Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 | Spesolimab 1200 mg - Randomized | 0.143 | 95% Confidence Interval 0.040 to 0.399 | Proportion of participants | |
| Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 | Placebo - Randomized | 0.125 | 95% Confidence Interval 0.022 to 0.471 | Proportion of participants | |
| Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 | Spesolimab 1200 mg - Randomized | 0.071 | 95% Confidence Interval 0.013 to 0.315 | Proportion of participants | |
| Proportion of Participants With Histological Remission at Week 12 | Placebo - Randomized | 0.500 | 95% Confidence Interval 0.215 to 0.785 | Proportion of participants | |
| Proportion of Participants With Histological Remission at Week 12 | Spesolimab 1200 mg - Randomized | 0.214 | 95% Confidence Interval 0.076 to 0.476 | Proportion of participants | |
| Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 | Placebo - Randomized | 0.000 | 95% Confidence Interval 0.000 to 0.324 | Proportion of participants | |
| Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 | Spesolimab 1200 mg - Randomized | 0.143 | 95% Confidence Interval 0.040 to 0.399 | Proportion of participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo - Actual | 6 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Spesolimab 1200 mg - Actual | 15 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo - Randomized | 8 | |
| Overall Study | STARTED | Spesolimab 1200 mg - Randomized | 14 | |
| Overall Study | Safety Analysis Set (SAF) | Placebo - Randomized | 7 | |
| Overall Study | Safety Analysis Set (SAF) | Spesolimab 1200 mg - Randomized | 15 | |
| Overall Study | COMPLETED | Placebo - Randomized | 8 | |
| Overall Study | COMPLETED | Spesolimab 1200 mg - Randomized | 12 | |
| Overall Study | NOT COMPLETED | Placebo - Randomized | 0 | |
| Overall Study | NOT COMPLETED | Spesolimab 1200 mg - Randomized | 2 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo - Actual | 0 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Spesolimab 1200 mg - Actual | 2 | 15 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo - Actual | 0 | 7 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Spesolimab 1200 mg - Actual | 1 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo - Actual | 0 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Spesolimab 1200 mg - Actual | 1 | 15 | |
| other | Episcleritis | Eye disorders | Placebo - Actual | 0 | 7 | |
| other | Episcleritis | Eye disorders | Spesolimab 1200 mg - Actual | 1 | 15 | |
| other | Ocular discomfort | Eye disorders | Placebo - Actual | 0 | 7 | |
| other | Ocular discomfort | Eye disorders | Spesolimab 1200 mg - Actual | 1 | 15 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Actual | 0 | 7 |
| Total, all-cause mortality | Spesolimab 1200 mg - Actual | 0 | 15 |
| Total, other adverse events | Placebo - Actual | 6 | 7 |
| Total, other adverse events | Spesolimab 1200 mg - Actual | 15 | 15 |
| Total, serious adverse events | Placebo - Actual | 1 | 7 |
| Total, serious adverse events | Spesolimab 1200 mg - Actual | 2 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Spesolimab 1200 mg - Actual vs Placebo - Actual: deaths from any cause | Trial comparisons |
| Spesolimab 1200 mg - Actual vs Placebo - Actual: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Spesolimab 1200 mg - Actual vs Placebo - Actual: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03123120
GET https://conductscience.org/api/trials/v1/NCT03123120/events?page=2