drugset / Trial / NCT05516758
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
Timeline
- Start
- 2022-08-31
- Primary completion
- 2023-11-20
- Completion
- 2025-01-17
Outcome
Met primary endpoint
Stopped: “Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis.”
registry analysis (superiority test); Peresolimab 1000 mg SC Q4W vs Placebo SC Q4W; p = 0.014; Odds Ratio (OR) 1.88 (95% CI 1.14 to 3.11); NCT05516758 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peresolimab | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | Peresolimab | Monoclonal antibody | 400 mg | Subcutaneous |
| Subject | Peresolimab | Monoclonal antibody | 1000 mg | Subcutaneous |