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

Phase 2

• Conditions: Rheumatoid Arthritis,Arthritis,Joint Diseases,Musculoskeletal Diseases,Rheumatic Diseases

• Registration Number: JPRN-jRCT2031220628
• Lead Sponsor: Masaki Takeshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving American College of Rheumatology (ACR)20 [ Time Frame: Baseline to Week 12 ]<br>ACR20 - 20% improvement in the ACR core set values