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Clinical Research of West Florida | Clearwater, FL

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A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)

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Lilly

Status and phase

Active, not recruiting
Phase 2

Conditions

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

Treatments

Drug: Peresolimab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05516758
2022-501425-20-00 (Other Identifier)
J1A-MC-KDAF (Other Identifier)
U1111-1283-9566 (Other Identifier)
18525

Details and patient eligibility

About

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.

Enrollment

491 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

491 participants in 4 patient groups

Peresolimab Dose 1
Experimental group
Description:
Participants will be given peresolimab by subcutaneous injection.
Treatment:
Drug: Peresolimab
Peresolimab Dose 2
Experimental group
Description:
Participants will be given peresolimab by subcutaneous injection.
Treatment:
Drug: Peresolimab
Peresolimab Dose 3
Experimental group
Description:
Participants will be given peresolimab by subcutaneous injection.
Treatment:
Drug: Peresolimab
Placebo
Active Comparator group
Description:
Participants will be give placebo by subcutaneous injection.
Treatment:
Drug: Placebo

Trial contacts and locations

136

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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