BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Summary
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are * to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) * to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) * To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.
Timeline
- Start
- 2018-03-27
- Primary completion
- 2020-05-18
- Completion
- 2020-05-18
Outcome
Missed primary endpoint
registry analysis (other test); Placebo vs 300 mg Spesolimab (BI 655130) SD; Risk Difference (RD) 0.042 (95% CI -0.105 to 0.202) NCT03482635 ↗
registry analysis (other test); Placebo vs 450 mg Spesolimab (BI 655130) q4w; Risk Difference (RD) 0.087 (95% CI -0.069 to 0.268) NCT03482635 ↗
registry analysis (other test); Placebo vs 1200 mg Spesolimab (BI 655130) q4w; Risk Difference (RD) 0.071 (95% CI -0.081 to 0.226) NCT03482635 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spesolimab | Monoclonal antibody | — | — |