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Trial record 1 of 1 for:    NCT05516758
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A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05516758
Recruitment Status : Recruiting
First Posted : August 26, 2022
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Drug: Peresolimab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : January 23, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Peresolimab Dose 1
Participants will be given peresolimab by subcutaneous injection
 Drug: Peresolimab
Administered subcutaneously (SC)
Experimental: Peresolimab Dose 2
Participants will be given peresolimab by subcutaneous injection
 Drug: Peresolimab
Administered subcutaneously (SC)
Experimental: Peresolimab Dose 3
Participants will be given peresolimab by subcutaneous injection
 Drug: Peresolimab
Administered subcutaneously (SC)
Active Comparator: Placebo
Participants will be give placebo by subcutaneous injection
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of Participants Achieving ACR50 or ACR70 [ Time Frame: Baseline to Week 12 ]
    ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values

  2. Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) [ Time Frame: Week 12 ]
  3. Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI) [ Time Frame: Week 12 ]
  4. Change from Baseline in DAS28-hsCRP [ Time Frame: Baseline, Week 12 ]
  5. Change from Baseline in CDAI [ Time Frame: Baseline, Week 12 ]
  6. 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) [ Time Frame: Baseline, Week 12 ]
  7. Pharmacokinetics (PK): Observed Trough Drug Concentration [ Time Frame: Baseline to Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516758


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05516758    
Other Study ID Numbers: 18525
J1A-MC-KDAF ( Other Identifier: Eli Lilly and Company )
2022-501425-20-00 ( Other Identifier: EU Trial Number )
U1111-1283-9566 ( Other Identifier: Universal Trial Number )
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: : Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
 Collagen Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases