Phase 2
N=6
A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease
Crohn Disease
Bottom Line
View on ClinicalTrials.gov: NCT03752970 ↗Enrolled (actual)
6
Serious AEs
4.4%
Results posted
Feb 2024
Primary outcome: Primary: The Total Number of Deregulated Genes at Week 4 — 0; 0 Deregulated genes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Spesolimab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Total Number of Deregulated Genes at Week 4 |
0; 0 | — |
| SECONDARY Number of Patients With Perianal Fistula Response at Week 12 |
7; 1 | — |
| SECONDARY Number of Patients With Perianal Fistula Remission at Week 12 |
6; 1 | — |
| SECONDARY Number of Patients With Combined Perianal Fistula Remission at Week 12 |
6; 1 | — |
Summary
This is a study in adults with Crohn's Disease who also have fistulas near the anus. The study has 2 parts. The first part is to find out more about what causes the fistulas. In this part of the study, tissue samples are taken from patients. The second part of the study tests whether a medicine called spesolimab (BI 655130) helps patients with Crohn's Disease.
Participants get study medication for 24 weeks. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets an intravenous drip that contains spesolimab every 4 weeks. The other group gets a placebo drip every 4 weeks. The placebo drip looks like the spesolimab drip, but contains no medicine.
The doctors regularly examine fistulas of the participants. The results of the fistula examinations are compared between the groups. The doctors also check the general health of the patients.
Eligibility Criteria
Inclusion criteria
- 18-75 years at date of signing informed consent
- Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Restrictions regarding women of childbearing potential. Restrictions regarding contraception for female patients are not applicable for Screening Cohort
- Diagnosis of clinical Crohn´s Disease ≥ 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report
- Has ≥ 1 perianal active* fistula(s) with clinical indication for seton drainage (≥ 4 weeks duration before enrolment, as a complication of CD) **
- Criteria for Active Fistula: As per clinical evaluation: Presence of spontaneous drainage or drainage after gentle finger compression at the external openings & as confirmed by radiological (MRI) exploration
** Patients who are screened with a seton drainage in place are eligible provided the drainage has not been in place for > 3 months and the patient meets the rest of the eligibility criteria
- Absent, mild or moderate clinical activity with CDAI 2 x ULN with ratio of direct/indirect >1 (patients with Gilbert's syndrome are not excluded), Alkaline Phosphatase >3 x ULN.
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- Previous enrolment in this trial (exception: patients of screening cohort may be enrolled in study cohort)
- Currently enrolled in another investigational device or drug trial
- Women who are pregnant, nursing, or who plan to become pregnant in the trial
- Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than Crohn´s disease, surgical procedure, medical examination finding (including vital signs and electrocardiogram (ECG)), or laboratory value at the screening visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data
- History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients or to contrast media
Data sourced from ClinicalTrials.gov (NCT03752970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.