NCT06041269

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

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: AnaptysBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Rosnilimab	PD-1 agonist antibody
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-08-31
• Primary completion: 2024-11-29
• Completion: 2025-05-30
• First posted: 2023-09-18
• Last updated: 2024-11-25

Locations

92 sites across 15 countries: United States, Belgium, Canada, Estonia, France, Georgia, Germany, Hungary, Italy, Moldova, Poland, Slovakia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study