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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

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

Intervention / Treatment
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* Drug: Peresolimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peresolimab Dose 1<br>Participants will be given peresolimab by subcutaneous injection. | Drug: Peresolimab<br>* Administered subcutaneously (SC)<br>|
| Experimental: Peresolimab Dose 2<br>Participants will be given peresolimab by subcutaneous injection. | Drug: Peresolimab<br>* Administered subcutaneously (SC)<br>|
| Experimental: Peresolimab Dose 3<br>Participants will be given peresolimab by subcutaneous injection. | Drug: Peresolimab<br>* Administered subcutaneously (SC)<br>|
| Active Comparator: Placebo<br>Participants will be give placebo by subcutaneous injection. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving American College of Rheumatology (ACR)20 | ACR20 - 20% improvement in the ACR core set values | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving ACR50 or ACR70 | ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values | Baseline to Week 12 | 
| Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) |  | Week 12 | 
| Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI) |  | Week 12 | 
| Change from Baseline in DAS28-hsCRP |  | Baseline, Week 12 | 
| Change from Baseline in CDAI |  | Baseline, Week 12 | 
| Change from Baseline in Patient-Reported ACR Core Set Values in Patient's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) |  | Baseline, Week 12 | 
| Pharmacokinetics (PK): Observed Trough Drug Concentration |  | Baseline to Week 12 |