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An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT05848258
Recruitment Status : Recruiting
First Posted : May 8, 2023
Last Update Posted : May 21, 2024
Sponsor:
Collaborator:
Rigel Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 28, 2023
First Posted Date  ICMJE May 8, 2023
Last Update Posted Date May 21, 2024
Actual Study Start Date  ICMJE May 23, 2023
Estimated Primary Completion Date February 25, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2023)
  • Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) [ Time Frame: Baseline, Week 12 ]
  • Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50 [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2023)
  • Phase 2a: Percentage of Participants Achieving ACR20/50/70 [ Time Frame: Baseline to Week 12 ]
  • Phase 2b: Change from Baseline in DAS28-hsCRP [ Time Frame: Baseline, Week 12 ]
  • Phase 2b: Percentage of Participants Achieving ACR20/70 [ Time Frame: Week 12 ]
  • Change from Baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in ACR Core Set Values 68 Tender Joint Counts [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline for Participant's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline the Duration and Severity of Morning Joint Stiffness [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline for SF-36 Mental Component Summary Score [ Time Frame: Baseline, Week 12 ]
  • Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801 [ Time Frame: Baseline through Week 20 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Official Title  ICMJE An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Brief Summary The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: LY3871801
    Administered orally
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: LY3871801 Phase 2a
    Participants will receive LY3871801 administered orally.
    Intervention: Drug: LY3871801
  • Placebo Comparator: Placebo Phase 2a
    Participants will receive placebo.
    Intervention: Drug: Placebo
  • Experimental: LY3871801 Dose 1 Phase 2b
    Participants will receive LY3871801 administered orally.
    Intervention: Drug: LY3871801
  • Experimental: LY3871801 Dose 2 Phase 2b
    Participants will receive LY3871801 administered orally.
    Intervention: Drug: LY3871801
  • Experimental: LY3871801 Dose 3 Phase 2b
    Participants will receive LY3871801 administered orally.
    Intervention: Drug: LY3871801
  • Placebo Comparator: Placebo Phase 2b
    Participants will receive placebo.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2023)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2026
Estimated Primary Completion Date February 25, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of adult-onset 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 a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (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 IIIa or 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina,   Czechia,   France,   Germany,   India,   Mexico,   Slovakia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05848258
Other Study ID Numbers  ICMJE 18516
J3P-MC-FTAF ( Other Identifier: Eli Lilly and Company )
2022-502994-40-00 ( Other Identifier: EU Trial Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Rigel Pharmaceuticals
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP