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

May 20, 2026 updated by: Eli Lilly and Company

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1440AAD
        • CENUDIAB
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigación
      • San Fernando, Argentina, 1646
        • Medicina Reumatológica
      • San Isidro, Argentina, 1642
        • Instituto de Alta Complejidad San Isidro
  • Czechia
      • Uherské Hradiště, Czechia, 686 01
        • Medical Plus
  • France
      • La Roche-sur-Yon, France, 85000
        • CHD Vendee
      • Montpellier, France, 34295
        • CHU Montpellier Lapeyronie Hospital
      • Nice, France, 06000
        • CHU de Nice
      • Orléans, France, 45067
        • Centre Hospitalier Régional d'Orléans
      • Paris, France, 75679
        • Hopitaux Universitaires Paris Centre-Hopital Cochin
      • Reims, France, 51092
        • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
      • Strasbourg, France, 67098
        • CHU Strasbourg-Hautepierre
  • Germany
      • Cologne, Germany, 50937
        • Universitaetsklinikum Koeln
      • Hamburg, Germany, 20095
        • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
  • Hungary
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Budapest, Hungary, 1027
        • Revita Clinic
      • Encs, Hungary, 3860
        • CRU Hungary Kft.
      • Hódmezővásárhely, Hungary, 6800
        • Vásárhelyi Sárkányfű KFT
      • Kistarcsa, Hungary, 2143
        • Kistarcsai Flor Ferenc Korhaz
      • Székesfehérvár, Hungary, 8000
        • Regia Med Kft
      • Veszprém, Hungary, 8200
        • Vital Medical Center
  • India
      • Ahmedabad, India, 380013
        • Avron Hospitals
      • Hubli, India, 580021
        • Sushruta Multispeciality Hospital & Research Centre
      • Nagpur, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Pune, India, 411001
        • Grant Medical Foundation - Ruby Hall Clinic
      • Pune, India, 411007
        • Medipoint Hospitals Pvt. Ltd.
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua
      • León, Mexico, 37000
        • Hospital Aranda de La Parra
      • Mexico City, Mexico, 06700
        • Biologicos Especializados
      • Monterrey, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
      • Morelia, Mexico, 58020
        • Cicmex Centro de Investigación Clínica de México
      • Mérida, Mexico, 97070
        • Medical Care and Research SA de CV
      • Mérida, Mexico, 97070
        • Kohler and Milstein Research S.A. de C.V.
      • San Luis Potosí City, Mexico, 78200
        • Centro de Atención e Investigación Cardiovascular del Potosí
      • Torreón, Mexico, 27000
        • CIMAB SA de CV
  • Poland
      • Bialystok, Poland, 15-707
        • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
      • Bytom, Poland, 41-902
        • Nzoz Bif-Med
      • Warsaw, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Poland, 02-665
        • Centrum Medyczne Reuma Park
  • United Kingdom
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
  • United States
    • California
      • Huntington Beach, California, United States, 92648
        • Newport Huntington Medical Group
    • Florida
      • Doral, Florida, United States, 33122
        • Integrity Clinical Research
      • Ocoee, Florida, United States, 34761
        • Advanced Clinical Research of Orlando - Ocoee
      • Weston, Florida, United States, 33331
        • Encore Medical Research - Weston
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Illinois
      • Willowbrook, Illinois, United States, 60527
        • Willow Rheumatology and Wellness PLLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Accurate Clinical Research, Inc
    • New York
      • Brooklyn, New York, United States, 11201
        • Joseph S. and Diane H. Steinberg Ambulatory Care Center
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Accellacare - Salisbury
    • Texas
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research, Inc
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Arthritis and Osteoporosis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY3871801 Phase 2a
Participants will receive LY3871801 administered orally.
Drug: LY3871801
Administered orally
Placebo Comparator: Placebo Phase 2a
Participants will receive placebo.
Drug: Placebo
Administered orally
Experimental: LY3871801 Dose 1 Phase 2b
Participants will receive LY3871801 administered orally.
Drug: LY3871801
Administered orally
Experimental: LY3871801 Dose 2 Phase 2b
Participants will receive LY3871801 administered orally.
Drug: LY3871801
Administered orally
Experimental: LY3871801 Dose 3 Phase 2b
Participants will receive LY3871801 administered orally.
Drug: LY3871801
Administered orally
Placebo Comparator: Placebo Phase 2b
Participants will receive placebo.
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Time Frame: Baseline, Week 12
Baseline, Week 12
Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Phase 2a: Percentage of Participants Achieving ACR20/50/70
Time Frame: Baseline to Week 12
Baseline to Week 12
Phase 2b: Change from Baseline in DAS28-hsCRP
Time Frame: Baseline, Week 12
Baseline, Week 12
Phase 2b: Percentage of Participants Achieving ACR20/70
Time Frame: Week 12
Week 12
Change from Baseline in Simplified Disease Activity Index (SDAI)
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline in Clinical Disease Activity Index (CDAI)
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline in ACR Core Set Values 68 Tender Joint Counts
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts
Time Frame: Baseline, Week 12
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
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
Baseline, Week 12
Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)
Time Frame: Baseline, Week 12
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
Baseline, Week 12
Change from Baseline the Duration and Severity of Morning Joint Stiffness
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline for SF-36 Mental Component Summary Score
Time Frame: Baseline, Week 12
Baseline, Week 12
Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801
Time Frame: Baseline through Week 20
Baseline through Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigel Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18516
  • J3P-MC-FTAF (Other Identifier: Eli Lilly and Company)
  • 2022-502994-40-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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