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

Phase 2

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: LY3871801

• Registration Number: NCT05848258
• Lead Sponsor: Eli Lilly and Company

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 available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-08
• Study Start: 2023-05-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2026-02
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Phase 2a	Placebo	Participants will receive placebo.
LY3871801 Phase 2a	LY3871801	Participants will receive LY3871801 administered orally.
LY3871801 Dose 1 Phase 2b	LY3871801	Participants will receive LY3871801 administered orally.
LY3871801 Dose 2 Phase 2b	LY3871801	Participants will receive LY3871801 administered orally.
LY3871801 Dose 3 Phase 2b	LY3871801	Participants will receive LY3871801 administered orally.
Placebo Phase 2b	Placebo	Participants will receive placebo.

Primary Outcome Measures

Name	Time	Method
Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)	Baseline, Week 12
Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Phase 2a: Percentage of Participants Achieving ACR20/50/70	Baseline to Week 12
Phase 2b: Percentage of Participants Achieving ACR20/70	Week 12
Change from Baseline in Simplified Disease Activity Index (SDAI)	Baseline, Week 12
Change from Baseline in ACR Core Set Values 68 Tender Joint Counts	Baseline, Week 12
Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts	Baseline, Week 12
Change from Baseline the Duration and Severity of Morning Joint Stiffness	Baseline, Week 12
Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score	Baseline, Week 12
Change from Baseline in Clinical Disease Activity Index (CDAI)	Baseline, Week 12
Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS	Baseline, Week 12
Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)	Baseline, Week 12
Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline, Week 12
Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801	Baseline through Week 20
Change from Baseline for SF-36 Mental Component Summary Score	Baseline, Week 12
Phase 2b: Change from Baseline in DAS28-hsCRP	Baseline, Week 12
Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS)	Baseline, Week 12

Trial Locations

Locations (114)

Newport Huntington Medical Group; 🇺🇸 Huntington Beach, California, United States

Integrity Clinical Research; 🇺🇸 Doral, Florida, United States

Advanced Clinical Research of Orlando - Ocoee; 🇺🇸 Ocoee, Florida, United States

Encore Medical Research - Weston; 🇺🇸 Weston, Florida, United States

Conquest Research; 🇺🇸 Winter Park, Florida, United States

Willow Rheumatology and Wellness PLLC; 🇺🇸 Willowbrook, Illinois, United States

Accurate Clinical Research, Inc; 🇺🇸 Houston, Texas, United States

Joseph S. and Diane H. Steinberg Ambulatory Care Center; 🇺🇸 Brooklyn, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Accellacare - Salisbury; 🇺🇸 Salisbury, North Carolina, United States

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