Trial · NCT05013385
A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
NCT05013385, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2023-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction. Trials, record NCT05013385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05013385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
- NCT number
- NCT05013385
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Fibrostenotic Crohn´s Disease
- Interventions
- Spesolimab, Placebo
- First posted
- 2021-08-19
- Last updated
- 2025-02-24
- Other registries' IDs
- eudract:2020-005770-99
- Results first posted
- 2023-06-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48 | At Week 48. | |
| Primary | Proportion of Patients With Radiographic Stenosis Response at Week 48 | At Week 48. | |
| Secondary | Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24 | At Week 24. | |
| Secondary | Proportion of Patients With Radiographic Stenosis Response at Week 24 | At Week 24 |
Source ClinicalTrials.gov
Outcomes4
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 Maintained Symptomatic Stenosis Response at Week 48 | At Week 48. | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | ||
| PRIMARY | Proportion of Patients With Radiographic Stenosis Response at Week 48 | At Week 48. | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | ||
| SECONDARY | Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24 | At Week 24. | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | ||
| SECONDARY | Proportion of Patients With Radiographic Stenosis Response at Week 24 | At Week 24 | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enrolled Patients | 5 | |
| Overall Study | Patients Who Entered the Randomized Blinded Treatment Period | Enrolled Patients | 0 | |
| Overall Study | COMPLETED | Enrolled Patients | 0 | |
| Overall Study | NOT COMPLETED | Enrolled Patients | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enrolled Patients | 0 | 0 |
| Total, other adverse events | Enrolled Patients | 0 | 0 |
| Total, serious adverse events | Enrolled Patients | 0 | 0 |
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/NCT05013385
GET https://conductscience.org/api/trials/v1/NCT05013385/registered