A Phase 2 interventional study of Spesolimab and Placebo in Fibrostenotic Crohn´s Disease, sponsored by Boehringer Ingelheim. Terminated at 4 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment.
Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months.
During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.
Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
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Exclusion Criteria:
Drug: Spesolimab
Drug: Placebo
Spesolimab
Placebo
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48
Time frame: At Week 48.
Proportion of Patients With Radiographic Stenosis Response at Week 48
Time frame: At Week 48.
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24
Time frame: At Week 24.
Proportion of Patients With Radiographic Stenosis Response at Week 24
Time frame: At Week 24
The trial was designed to have a Lead-in Period where background medication is optimized, a Randomized Blinded Treatment Period and a Follow-up Period. At the end of the Lead-in Period, if eligibility criteria were fulfilled patients would have been randomized to either spesolimab (BI 655130) or placebo for the blinded treatment period. The trial was terminated when only 5 patients had entered the lead-in period. No patient was randomized and received spesolimab or placebo.
| Milestone | Enrolled Patients |
|---|---|
| Started | 5 |
| Patients who entered the randomized blinded treatment period | 0 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Sponsor's decision to terminate the trial | 5 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled Patients | — | — | — |
Enrolled patients: Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial.
| Age, Continuous(Years) | Enrolled Patients |
|---|---|
| Mean | 34.2 ± 10.8 |
| Sex: Female, Male(Participants) | Enrolled Patients |
|---|---|
| Female | 2 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Enrolled Patients |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Enrolled Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spesolimab