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

JRCT ID: jRCT2031220628

Registered date:09/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis,Arthritis,Joint Diseases,Musculoskeletal Diseases,Rheumatic Diseases
• Date of first enrollment: 15/02/2023
• Target sample size: 420
• Countries of recruitment: Argentina,Japan,Canada,Japan,China,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Puerto Rico,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Peresolimab
Administered subcutaneously (SC)
-Drug: Placebo
Administered SC

Study Arms
-Experimental: Peresolimab Dose 1
Participants will be given peresolimab by subcutaneous injection
Intervention: Drug: Peresolimab
-Experimental: Peresolimab Dose 2
Participants will be given peresolimab by subcutaneous injection
Intervention: Drug: Peresolimab
-Experimental: Peresolimab Dose 3
Participants will be given peresolimab by subcutaneous injection
Intervention: Drug: Peresolimab
-Active Comparator: Placebo
Participants will be give placebo by subcutaneous injection
Intervention: Drug: Placebo

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05516758