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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 : September 15, 2023
Sponsor:
Collaborator:
Rigel Pharmaceuticals
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 evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: LY3871801 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Actual Study Start Date : May 23, 2023
Estimated Primary Completion Date : February 25, 2026
Estimated Study Completion Date : July 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3871801 Phase 2a
Participants will receive LY3871801 administered orally.
 Drug: LY3871801
Administered orally
Placebo Comparator: Placebo Phase 2a
Participants will receive placebo.
 Drug: Placebo
Administered orally
Experimental: LY3871801 Dose 1 Phase 2b
Participants will receive LY3871801 administered orally.
 Drug: LY3871801
Administered orally
Experimental: LY3871801 Dose 2 Phase 2b
Participants will receive LY3871801 administered orally.
 Drug: LY3871801
Administered orally
Experimental: LY3871801 Dose 3 Phase 2b
Participants will receive LY3871801 administered orally.
 Drug: LY3871801
Administered orally
Placebo Comparator: Placebo Phase 2b
Participants will receive placebo.
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) [ Time Frame: Baseline, Week 12 ]
  2. Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50 [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Phase 2a: Percentage of Participants Achieving ACR20/50/70 [ Time Frame: Baseline to Week 12 ]
  2. Phase 2b: Change from Baseline in DAS28-hsCRP [ Time Frame: Baseline, Week 12 ]
  3. Phase 2b: Percentage of Participants Achieving ACR20/70 [ Time Frame: Week 12 ]
  4. Change from Baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline, Week 12 ]
  5. Change from Baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, Week 12 ]
  6. Change from Baseline in ACR Core Set Values 68 Tender Joint Counts [ Time Frame: Baseline, Week 12 ]
  7. Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts [ Time Frame: Baseline, Week 12 ]
  8. 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 ]
  9. Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS [ Time Frame: Baseline, Week 12 ]
  10. Change from Baseline for Participant's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 12 ]
  11. Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 12 ]
  12. Change from Baseline the Duration and Severity of Morning Joint Stiffness [ Time Frame: Baseline, Week 12 ]
  13. Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score [ Time Frame: Baseline, Week 12 ]
  14. Change from Baseline for SF-36 Mental Component Summary Score [ Time Frame: Baseline, Week 12 ]
  15. Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801 [ Time Frame: Baseline through Week 20 ]

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 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
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): NCT05848258


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
Rigel Pharmaceuticals
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: NCT05848258    
Other Study ID Numbers: 18516
J3P-MC-FTAF ( Other Identifier: Eli Lilly and Company )
2022-502994-40-00 ( Other Identifier: EU Trial Number )
First Posted: May 8, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023

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