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A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease | Clinical Trials | Clareo Health

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A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease

NCT03752970•Boehringer Ingelheim

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 \< 250. CDAI is not applicable for Screening Cohort
•Demonstrated in the past inadequate fistula response or loss of response or have had unacceptable side effects with approved doses of at least one of the following compounds: immunosuppressive agents (e.g. thiopurines, methotrexate), TNFɑ antagonists (e.g. infliximab, adalimumab, certolizumab pegol; or respective biosimilars), vedolizumab, ustekinumab, azathioprine and / or antibiotics
•Patients with family history of colorectal cancer or personal history of increased colorectal cancer risk must have had a negative ileocolorectal cancer screening within \<1 year prior to screening per local guidance
•Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

•Complications of Crohn's Disease such as symptomatic strictures, functional stenosis distal from fistula(s), short gut syndrome, or any other manifestation that might require surgery, could preclude the use of the PDAI and CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 655130
•Rectovaginal fistulas
•Anticipated to require surgical intervention for CD including any fistula surgical procedures (except seton drainage)
•Has an abscess that the investigator feels requires drainage beyond fistula drainage with a seton (based on either clinical assessment or MRI)
•Any kind of bowel resection or diversion within 6 months or any other intraabdominal surgery within 3 months prior to screening.
•Ileostomy, colostomy or known fixed symptomatic stenosis of the intestine at screening
•Positive stool examinations for C. difficile or other intestinal pathogens \< 30 days prior to screening
•\-- Evidence of colonic mucosal dysplasia or colonic adenomas, unless properly removed (properly according to the investigator's assessment)
•Faecal Microbiota transplant (FMT) within 6 months prior to randomization
•Treatment with:
+25 more criteria

Locations (10)

AKH - Medical University of Vienna

Vienna, Austria

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Herlev and Gentofte Hospital

Herlev, Denmark

Universitätsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Semmelweis University

Budapest, Hungary

Amsterdam UMC, Locatie AMC

Amsterdam, Netherlands

Inje University Haeundae Paik Hospital

Busan, South Korea

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Key Dates

Start Date

February 5, 2019

Primary Completion Date

December 1, 2021

Completion Date

July 4, 2022

Last Updated

October 16, 2025

Enrollment

ACTUAL participants

Conditions

Crohn Disease

Interventions

Spesolimab

DRUG

Placebo

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

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Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study