drugset / Trial / NCT06041269

A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)

NCT06041269 ↗

Phase 2 Active not recruiting 420 enrolled AnaptysBio, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

Timeline

Start
2023-08-31
Primary completion
2024-11-29
Completion
2025-05-30

Outcome

Met primary endpoint

release “The trial achieved its primary endpoint of the mean change from baseline in DAS-28 CRP at Week 12 for all three doses of rosnilimab” anaptysbio.com ↗

release “Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS28-CRP score across all three rosnilimab doses vs. placebo” anaptysbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosnilimab Monoclonal antibody — Subcutaneous

Indications