A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.
Timeline
- Start
- 2024-05-01
- Primary completion
- 2025-06-16
- Completion
- 2025-06-16
Outcome
Missed primary endpoint
Stopped: “Based on a futility analysis, which suggested that the Moonglow study was unlikely to meet its primary endpoint.”
registry analysis (superiority test); Arm A: Vixarelimab 720 mg Q2W vs Arm C: Placebo; p = 1.0000; Adjusted Difference in Remission Rates 0.0 (95% CI -17.11 to 17.11) NCT06137183 ↗
registry analysis (superiority test); Arm B: Vixarelimab 720 mg Q4W vs Arm C: Placebo; p = 0.3010; Adjusted Difference in Remission Rates -7.7 (95% CI -21.94 to 6.47) NCT06137183 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vixarelimab | Monoclonal antibody | — | Subcutaneous |