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