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RECRUITINGPHASE2

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

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

NCT05848258•Eli Lilly and Company

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (57)

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

Lake Charles, Louisiana, 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

Key Dates

Start Date

May 23, 2023

Primary Completion Date

February 1, 2026

Completion Date

July 1, 2026

Last Updated

December 9, 2025

Enrollment

380

ESTIMATED participants

Conditions

Rheumatoid Arthritis

Interventions

LY3871801

DRUG

Placebo

DRUG

Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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