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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • 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 Locations

  • Argentina
      • Buenos Aires, Argentina, C1440AAD
        • CENUDIAB
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigacion
      • 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
        • Biológicos 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

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
Intervention / Treatment
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

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

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

Eli Lilly and Company

Collaborators

Rigel Pharmaceuticals

Investigators

  • 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)

May 23, 2023

Primary Completion (Actual)

December 8, 2025

Study Completion (Actual)

April 22, 2026

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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