A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
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.