A Phase 2b Double-Blind Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis

Brief description of study

This study includes a . screening period . 12-week double-blind, placebo-controlled treatment period . 48-week double-blind treatment period, and . post-treatment follow-up. At Week 12, participants receiving placebo Q4W will begin receiving either 400 mg or 1000 mg peresolimab Q4W. Treatment assignment will be blinded and the participants will continue their assigned peresolimab dose and dosing frequency until the end of the study. Participants randomly assigned to 100 mg peresolimab Participants receiving 100 mg peresolimab will continue their assigned dose and dosing frequency throughout the duration of the treatment period. No changes will occur. Participants randomly assigned to 400 mg or 1000 mg peresolimab Participants receiving 400 mg or 1000 mg peresolimab will continue their assigned dose and dosing frequency until Week 24. At Week 24, participants may be switched to Q12W dosing following assessment of CDAI scores, unless they received rescue medication prior to Week 24.


Clinical Study Identifier: s22-01276
ClinicalTrials.gov Identifier: NCT05516758
Principal Investigator: David H. Goddard.
Other Investigators: Lauren E. Wong, Andres M. Piatti.


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