A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
Inclusion Criteria:
Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
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.
Exclusion Criteria:
Have Class IV RA according to ACR revised criteria.
Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
poorly controlled diabetes or hypertension
chronic kidney disease stage IIIb, IV, or V
symptomatic heart failure according to New York Heart Association Class II, III, or IV
myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
severe chronic pulmonary disease, for example, requiring oxygen therapy
major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
Rochester Hills, Michigan 48307, United States
CABA, Buenos Aires C1015, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Aires 1417, Argentina
CABA, Buenos Aires F.D. 1406, Argentina
CABA, Ciudad Autónoma de Buenos Aire C1430EGF, Argentina
San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
Budapest, Pest County 1027, Hungary
Bunkyo-ku, Tokyo 113-8431, Japan