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

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.

Key Inclusion Criteria:

• Aged 18 years or older
• A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial
• Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial
• Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment

Key Exclusion Criteria:

• History of an inflammatory joint disease other than Rheumatoid Arthritis
• Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator
• History of cancer within the last 5 years (except for some skin cancers)
• Any known or suspected condition that would compromise immune status
• Pregnant or breastfeeding women