Trial · NCT03100864
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
NCT03100864, Phase 2, Completed, Boehringer Ingelheim; results first posted 2020-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients. Trials, record NCT03100864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03100864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
- NCT number
- NCT03100864
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Colitis, Ulcerative
- Interventions
- Spesolimab
- First posted
- 2017-04-04
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2017-000100-20
- Results first posted
- 2020-11-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12). | The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value \< 0.01 and a fold change ≤ -1.3 or ≥ 1.3. |
| Secondary | Percent Change in C-reactive Protein (CRP) From Baseline to Week 12 | Measurements done at baseline (day -8 to -6) and week 12 (day 85). | Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85). |
| Secondary | Percent Change in Faecal Calprotectin From Baseline to Week 12 | Measurements done at baseline (day -8 to -6) and week 12 (day 85). | Percent change in faecal calprotectin from baseline to week 12 (day 85). |
| Secondary | Percent Change in Faecal Lactoferrin From Baseline to Week 12 | Measurements done at baseline (day -8 to -6) and week 12 (day 85). | Percent change in faecal lactoferrin from baseline to week 12 (day 85). |
| Secondary | Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12 | Week 12 (day 85) following start of treatment. | Number of participants with clinical remission (defined as Mayo score ≤2 points, and all subscores ≤1 point) at Week 12. The Mayo score is a composite disease activity score consisting of 4 items or subscores: stool frequency (relative to normal), rectal bleeding, physician's global assessment (PGA), and endoscopic appearance. The overall range of the Mayo score was 0 to 12 (higher scores being worse) and each subscore had a range of 0 to 3. |
| Secondary | Number of Patients With Drug Related Adverse Events (AEs) | Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days. | Number of patients with drug related adverse events (AEs) during the on-treatment period. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12). | Completers analysis set: completed the trial medication through to end of trial visit, had a baseline and at least 1 post baseline measurement for any clinical efficacy or biomarker endpoint without any Important protocol deviation flagged for exclusion or rescue use on or after Visit 1b but prior to administration of the first dose of spesolimab. | deregulated genes | NUMBER |
| SECONDARY | Percent Change in C-reactive Protein (CRP) From Baseline to Week 12 | Measurements done at baseline (day -8 to -6) and week 12 (day 85). | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | percentage change (%) | MEDIAN |
| SECONDARY | Percent Change in Faecal Calprotectin From Baseline to Week 12 | Measurements done at baseline (day -8 to -6) and week 12 (day 85). | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | percentage change (%) | MEDIAN |
| SECONDARY | Percent Change in Faecal Lactoferrin From Baseline to Week 12 | Measurements done at baseline (day -8 to -6) and week 12 (day 85). | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | percentage change (%) | MEDIAN |
| SECONDARY | Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12 | Week 12 (day 85) following start of treatment. | Full analysis set (FAS): patients who received at least 1 dose of study drug, who had a baseline and at least 1 post baseline measurement for any clinical efficacy or biomarker endpoint without any Important protocol deviation flagged for exclusion or rescue use on or after Visit 1b but prior to administration of the first dose of spesolimab. | Participants | NUMBER |
| SECONDARY | Number of Patients With Drug Related Adverse Events (AEs) | Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days. | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | 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 |
|---|---|---|---|---|---|
| The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | Change from baseline to Day 1 | 3 | deregulated genes | |
| The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | Change from baseline to Day 4 | 5 | deregulated genes | |
| The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | Change from baseline to Day 15 (week 2) | 2 | deregulated genes | |
| The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | Change from baseline to Day 57 (week 8) | 7 | deregulated genes | |
| The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | Change from baseline to Day 85 (week 12) | 9 | deregulated genes | |
| Percent Change in C-reactive Protein (CRP) From Baseline to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | -79.6 | Full Range -97.9 to 936.7 | percentage change (%) | |
| Percent Change in Faecal Calprotectin From Baseline to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | 13.0 | Full Range -98.7 to 219.3 | percentage change (%) | |
| Percent Change in Faecal Lactoferrin From Baseline to Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | 0.4 | Full Range -99.7 to 388.7 | percentage change (%) | |
| Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12 | Spesolimab 1200 mg Intravenous (i.v.) | 0 | 95% Confidence Interval 0.000 to 0.434 | Participants | |
| Number of Patients With Drug Related Adverse Events (AEs) | Spesolimab 1200 mg Intravenous (i.v.) | 6 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spesolimab 1200 mg Intravenous (i.v.) | 8 | |
| Overall Study | COMPLETED | Spesolimab 1200 mg Intravenous (i.v.) | 8 | |
| Overall Study | NOT COMPLETED | Spesolimab 1200 mg Intravenous (i.v.) | 0 |
Source ClinicalTrials.gov
Adverse events25
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Conjunctival haemorrhage | Eye disorders | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Eye inflammation | Eye disorders | Spesolimab 1200 mg Intravenous (i.v.) | 2 | 8 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Fatigue | General disorders | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Gastrointestinal infection | Infections and infestations | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 | |
| other | Nasopharyngitis | Infections and infestations | Spesolimab 1200 mg Intravenous (i.v.) | 4 | 8 | |
| other | Tonsillitis | Infections and infestations | Spesolimab 1200 mg Intravenous (i.v.) | 1 | 8 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spesolimab 1200 mg Intravenous (i.v.) | 0 | 8 |
| Total, other adverse events | Spesolimab 1200 mg Intravenous (i.v.) | 8 | 8 |
| Total, serious adverse events | Spesolimab 1200 mg Intravenous (i.v.) | 2 | 8 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03100864
GET https://conductscience.org/api/trials/v1/NCT03100864/events?page=2