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Evaluating LY3871801 for treating rheumatoid arthritis in adults

An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Phase 2 Interventional Eli Lilly and Company · NCT05848258

This study is testing a new medication called LY3871801 to see if it can help adults with moderate to severe rheumatoid arthritis who haven't had enough relief from other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment380 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations58 sites (Huntington Beach, California and 57 other locations)
Trial IDNCT05848258 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of LY3871801 in adults diagnosed with moderately-to-severe rheumatoid arthritis (RA). Participants must have had an inadequate response to previous treatments, including conventional and biologic therapies. The study will involve administering either LY3871801 or a placebo to determine the drug's effectiveness in managing RA symptoms. The trial is designed to adapt based on interim results to optimize patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with a diagnosis of rheumatoid arthritis for at least three months and who have moderately-to-severe active disease.

Not a fit: Patients with Class IV rheumatoid arthritis or significant concurrent medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with rheumatoid arthritis who have not responded to existing therapies.

How similar studies have performed: Other studies have shown promise with similar biologic approaches in treating rheumatoid arthritis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Huntington Beach, California and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rheumatoid Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.