A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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

• ≥6 swollen joints based on 66 joint count, and

• ≥6 tender joints based on 68 joint count.

• 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 response 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,

• systemic lupus erythematosus

• psoriatic arthritis

• axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis

• reactive arthritis

• gout

• scleroderma

• polymyositis

• dermatomyositis

• active fibromyalgia, or

• multiple sclerosis