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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis (NCT05848258) is a Phase 2 interventional studying Rheumatoid Arthritis, sponsored by Eli Lilly and Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Rheumatoid Arthritis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 380 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

LY3871801

Administered orally

DRUG

Placebo

Administered orally

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
Accurate Clinical Research, Inc
Houston, Texas, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, United States
CIPREC
Buenos Aires, Argentina
Mautalen Salud e Investigación
Buenos Aires, Argentina
CENUDIAB
Buenos Aires, Argentina
Medicina Reumatológica
San Fernando, Argentina
Instituto de Alta Complejidad San Isidro
San Isidro, Argentina
Medical Plus
Uherské Hradiště, Czechia
CHD Vendee
La Roche-sur-Yon, France
CHU Montpellier Lapeyronie Hospital
Montpellier, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05848258), the sponsor (Eli Lilly and Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05848258 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05848258?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05848258?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05848258. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05848258. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.