Trial · NCT04362254
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
NCT04362254, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2024-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials. Trials, record NCT04362254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04362254
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
- NCT number
- NCT04362254
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Crohn Disease
- Interventions
- Spesolimab
- First posted
- 2020-04-24
- Last updated
- 2025-02-24
- Other registries' IDs
- eudract:2019-001673-93
- Results first posted
- 2024-11-05
- Limitations and caveats
- This trial was terminated early due to BI's decision to terminate the development of spesolimab in fistulising and fibrostenotic Crohn's disease.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment | First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks. | Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) during maintenance treatment. The incidence rate was calculated as Incidence rate = 100 \* number of patients with TEAE / Total TEAE-specific time at risk. Where the Time at risk (for patients who experienced a TEAE) was calculated as Time at Risk (in subject years) = ((date of onset of AE - study drug start date) +1 day) / 365.25 and Time at risk (for patients who did not experience a TEAE) Time at Risk (in subject years) = ((date of the end of time at risk - study drug start date) +1 day) / 365.25. |
| Secondary | Proportion of Patients With Perianal Fistula Remission | Baseline, week 48 and 96 of treatment. | Proportion of patients with perianal fistula remission at weeks 48 and 96. Perianal fistula remission was defined as closure of all external openings, i.e. no drainage and discharge despite gentle finger compression, that were open and draining at baseline of the parent trial and closure of all external openings that were newly emerged during the parent trial or this trial. |
| Secondary | Proportion of Patients With Perianal Fistula Response | Baseline, week 48 and 96 of treatment. | Proportion of patients with perianal fistula response at weeks 48 and 96. Perianal fistula response was defined as closure and no drainage and discharge despite gentle finger compression of at least 50% in number of external openings regardless of the onset time, compared with the number of open and drainage fistulas at baseline of the parent trial. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment | First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks. | The safety set (SAF) included all patients who received at least one dose of trial drug in the overall maintenance period. | Patients with TEAE per 100 patient years | NUMBER |
| SECONDARY | Proportion of Patients With Perianal Fistula Remission | Baseline, week 48 and 96 of treatment. | The data was not collected as intended and the remission cannot be reported. | ||
| SECONDARY | Proportion of Patients With Perianal Fistula Response | Baseline, week 48 and 96 of treatment. | The data was not collected as intended and the response cannot be reported. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment | Spesolimab | 816.6 | Patients with TEAE per 100 patient years |
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 | 12 | |
| Overall Study | COMPLETED | Spesolimab | 0 | |
| Overall Study | NOT COMPLETED | Spesolimab | 12 |
Source ClinicalTrials.gov
Adverse events34
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 | Abdominal pain | Gastrointestinal disorders | Spesolimab | 1 | 12 | |
| other | Anal polyp | Gastrointestinal disorders | Spesolimab | 1 | 12 | |
| other | Rectal stenosis | Gastrointestinal disorders | Spesolimab | 1 | 12 | |
| other | Inflammation | General disorders | Spesolimab | 1 | 12 | |
| other | Injection site erythema | General disorders | Spesolimab | 3 | 12 | |
| other | Injection site reaction | General disorders | Spesolimab | 1 | 12 | |
| other | Injection site swelling | General disorders | Spesolimab | 1 | 12 | |
| other | Pyrexia | General disorders | Spesolimab | 1 | 12 | |
| other | Seasonal allergy | Immune system disorders | Spesolimab | 1 | 12 | |
| other | COVID-19 | Infections and infestations | Spesolimab | 6 | 12 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spesolimab | 0 | 12 |
| Total, other adverse events | Spesolimab | 11 | 12 |
| Total, serious adverse events | Spesolimab | 1 | 12 |
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/NCT04362254
GET https://conductscience.org/api/trials/v1/NCT04362254/events?page=2