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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spesolimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Spesolimab | Monoclonal antibody | 600 mg | Subcutaneous |