drugset / 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 12 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials

Timeline

Start
2020-05-15
Primary completion
2022-05-14
Completion
2022-09-23

Outcome

Outcome not reported

Stopped: “BI's decision to terminate the development of spesolimab in fistulising and fibrostenotic Crohn's disease.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Spesolimab Monoclonal antibody 300 mg Subcutaneous
Subject Spesolimab Monoclonal antibody 600 mg Subcutaneous

Indications