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

• ClinicalTrials.gov Identifier: NCT05848258
• Recruitment Status: Recruiting
• First Posted: May 8, 2023
• Last Update Posted: February 29, 2024
• Sponsor: Eli Lilly and Company
• Collaborator: Rigel Pharmaceuticals
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: April 28, 2023
• First Posted Date: May 8, 2023
• Last Update Posted Date: February 29, 2024
• Actual Study Start Date: May 23, 2023
• Estimated Primary Completion Date: February 25, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis

Intervention

• Drug: LY3871801
  Administered orally
• Drug: Placebo
  Administered orally

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 28, 2023): 380
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 15, 2026
• Estimated Primary Completion Date: February 25, 2026 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Argentina, Czechia, France, Germany, India, Mexico, Slovakia, United Kingdom, United States

Administrative Information

• NCT Number: NCT05848258
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Rigel Pharmaceuticals

Investigators

• 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: February 2024