Trial · NCT03482635
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
NCT03482635, Phase 2, Phase 3, Completed, Boehringer Ingelheim; results first posted 2021-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis. Trials, record NCT03482635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03482635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
- NCT number
- NCT03482635
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Colitis, Ulcerative
- Interventions
- Spesolimab, Placebo
- First posted
- 2018-03-29
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2017-004230-28
- Results first posted
- 2021-06-11
- Limitations and caveats
- Due to recruitment issues during phase II, the trial was prematurely ended according to a protocol defined option. Phase III was not conducted. The trial was completed as defined in the protocol.
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 Patients With Clinical Remission at Week 12 | At week 12. | Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 \[if drop ≥1 from baseline\] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson. |
| Secondary | Proportion of Patients With Clinical Response at Week 12 | At week 12. | Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson. |
| Secondary | Proportion of Patients With Endoscopic Improvement at Week 12 | At week 12. | Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson. |
| Secondary | Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12 | At week 12. | Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed. |
| Secondary | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12 | At baseline and at week 12. | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12. The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID). Mean is adjusted mean. |
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 Patients With Clinical Remission at Week 12 | At week 12. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Proportion of Participants | NUMBER |
| SECONDARY | Proportion of Patients With Clinical Response at Week 12 | At week 12. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With Endoscopic Improvement at Week 12 | At week 12. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12 | At week 12. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Proportion of participants | NUMBER |
| SECONDARY | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12 | At baseline and at week 12. | Modified Randomised Set (m-RS): The m-RS included all patients in the RS who had a baseline and at least 1 post-baseline measurement for the endpoint under consideration. Treatment assignment was randomised. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Clinical Remission at Week 12 | Placebo | 0.00 | 95% Confidence Interval 0.000 to 0.143 | Proportion of Participants | |
| Proportion of Patients With Clinical Remission at Week 12 | 300 mg Spesolimab (BI 655130) SD | 0.042 | 95% Confidence Interval 0.007 to 0.202 | Proportion of Participants | |
| Proportion of Patients With Clinical Remission at Week 12 | 450 mg Spesolimab (BI 655130) q4w | 0.087 | 95% Confidence Interval 0.024 to 0.268 | Proportion of Participants | |
| Proportion of Patients With Clinical Remission at Week 12 | 1200 mg Spesolimab (BI 655130) q4w | 0.071 | 95% Confidence Interval 0.020 to 0.226 | Proportion of Participants | |
| Proportion of Patients With Clinical Response at Week 12 | Placebo | 0.217 | 95% Confidence Interval 0.097 to 0.419 | Proportion of participants | |
| Proportion of Patients With Clinical Response at Week 12 | 300 mg Spesolimab (BI 655130) SD | 0.167 | 95% Confidence Interval 0.067 to 0.359 | Proportion of participants | |
| Proportion of Patients With Clinical Response at Week 12 | 450 mg Spesolimab (BI 655130) q4w | 0.261 | 95% Confidence Interval 0.125 to 0.465 | Proportion of participants | |
| Proportion of Patients With Clinical Response at Week 12 | 1200 mg Spesolimab (BI 655130) q4w | 0.250 | 95% Confidence Interval 0.127 to 0.434 | Proportion of participants | |
| Proportion of Patients With Endoscopic Improvement at Week 12 | Placebo | 0.000 | 95% Confidence Interval 0.000 to 0.143 | Proportion of participants | |
| Proportion of Patients With Endoscopic Improvement at Week 12 | 300 mg Spesolimab (BI 655130) SD | 0.083 | 95% Confidence Interval 0.023 to 0.258 | Proportion of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | STARTED | 300 mg Spesolimab (BI 655130) SD | 24 | |
| Overall Study | STARTED | 450 mg Spesolimab (BI 655130) q4w | 23 | |
| Overall Study | STARTED | 1200 mg Spesolimab (BI 655130) q4w | 28 | |
| Overall Study | Treated | Placebo | 23 | |
| Overall Study | Treated | 300 mg Spesolimab (BI 655130) SD | 24 | |
| Overall Study | Treated | 450 mg Spesolimab (BI 655130) q4w | 23 | |
| Overall Study | Treated | 1200 mg Spesolimab (BI 655130) q4w | 27 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | 300 mg Spesolimab (BI 655130) SD | 21 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events88
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 | 5 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | 300 mg Spesolimab (BI 655130) SD | 1 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | 450 mg Spesolimab (BI 655130) q4w | 0 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | 1200 mg Spesolimab (BI 655130) q4w | 0 | 27 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 23 | |
| other | Abdominal pain upper | Gastrointestinal disorders | 300 mg Spesolimab (BI 655130) SD | 0 | 24 | |
| other | Abdominal pain upper | Gastrointestinal disorders | 450 mg Spesolimab (BI 655130) q4w | 0 | 23 | |
| other | Abdominal pain upper | Gastrointestinal disorders | 1200 mg Spesolimab (BI 655130) q4w | 2 | 27 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Placebo | 0 | 23 | |
| other | Colitis ulcerative | Gastrointestinal disorders | 300 mg Spesolimab (BI 655130) SD | 2 | 24 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, all-cause mortality | 300 mg Spesolimab (BI 655130) SD | 0 | 24 |
| Total, all-cause mortality | 450 mg Spesolimab (BI 655130) q4w | 0 | 23 |
| Total, all-cause mortality | 1200 mg Spesolimab (BI 655130) q4w | 0 | 27 |
| Total, other adverse events | Placebo | 5 | 23 |
| Total, other adverse events | 300 mg Spesolimab (BI 655130) SD | 7 | 24 |
| Total, other adverse events | 450 mg Spesolimab (BI 655130) q4w | 7 | 23 |
| Total, other adverse events | 1200 mg Spesolimab (BI 655130) q4w | 17 | 27 |
| Total, serious adverse events | Placebo | 4 | 23 |
| Total, serious adverse events | 300 mg Spesolimab (BI 655130) SD | 3 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT03482635
GET https://conductscience.org/api/trials/v1/NCT03482635/events?page=2