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

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 atleast 3 months and be on stable dosages for at least 8 weeks prior to joining andthroughout the trial

• Have had an inadequate response to, or loss of response or intolerance to at least 1conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targetedsynthetic 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