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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases

In brief

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.

Key facts

Study ID

NCT05516758

Run by

Eli Lilly and Company

People needed

491

Starts

2022-08-31

Expected to finish

2025-01-17

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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,
• 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

Where it is running

• Accel Research Sites - Birmingham Clinical Research Unit — Birmingham, Alabama, United States
• Arizona Arthritis & Rheumatology Research PLLC — Gilbert, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Associates, PLLC — Phoenix, Arizona, United States
• Medvin Clinical Research - Metyas — Covina, California, United States
• St Joseph Heritage Healthcare — Fullerton, California, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• Desert Medical Advances — Rancho Mirage, California, United States
• Dan La, MD Inc — Tujunga, California, United States
• Wolverine Clinical Trials — Tustin, California, United States
• Medvin Clinical Research - Su — Whittier, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Tekton Research - Fort Collins - East Harmony Road — Fort Collins, Colorado, United States
• HARAC Research Corp — Avon Park, Florida, United States
• Encore Medical Research of Boynton Beach — Boynton Beach, Florida, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Baycare Medical Group — St. Petersburg, Florida, United States
• West Broward Rheumatology Associates — Tamarac, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Baycare Medical Group — Tampa, Florida, United States
• Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States
• Tonan Hospital — Sapporo, Hokkaido, Japan

Full record on ClinicalTrials.gov

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