drugset / Trial / NCT05516758

A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

NCT05516758 ↗

Phase 2 Terminated 491 enrolled Eli Lilly and Company
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

EvaluationDrugModalityDoseRoute
Subject Peresolimab Monoclonal antibody 100 mg Subcutaneous
Subject Peresolimab Monoclonal antibody 400 mg Subcutaneous
Subject Peresolimab Monoclonal antibody 1000 mg Subcutaneous

Indications