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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases
• Interventions: Drug: Peresolimab; Drug: Placebo

• Registration Number: NCT05516758
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-08-31
• Primary Completion: 2023-11-20
• Disposition First Posted: 2024-03-12
• Disposition First Submitted: 2024-05-01
• Status Verified: 2025-01
• Study Completion: 2025-01-17
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peresolimab Dose 1	Peresolimab	Participants will be given peresolimab by subcutaneous injection.
Peresolimab Dose 2	Peresolimab	Participants will be given peresolimab by subcutaneous injection.
Placebo	Placebo	Participants will be give placebo by subcutaneous injection.
Peresolimab Dose 3	Peresolimab	Participants will be given peresolimab by subcutaneous injection.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI)	Week 12
Percentage of Participants Achieving ACR50 or ACR70	Baseline to Week 12	ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values
Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)	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
Change from Baseline in DAS28-hsCRP	Baseline, Week 12
Change from Baseline in CDAI	Baseline, Week 12
Pharmacokinetics (PK): Observed Trough Drug Concentration	Baseline to Week 12

Trial Locations

Locations (127)

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; 🇺🇸 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

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