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

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

LY3871801

Placebo

Clinical Study ID

NCT05848258
18516
J3P-MC-FTAF
2022-502994-40-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of adult-onset RA for at least 3 months prior to screening asdefined by the 2010 ACR/European League Against Rheumatism (EULAR) classificationcriteria.

  • Have moderately-to-severely active RA at screening and baseline, defined by thepresence 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 ofresponse) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.

Exclusion

Exclusion Criteria:

  • Have Class IV RA according to ACR revised criteria

  • Have presence of 1 or more significant concurrent medical conditions perinvestigator 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 ischemicattack 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 andnon-radiographic axial spondyloarthritis

  • reactive arthritis

  • gout

  • scleroderma

  • polymyositis

  • dermatomyositis

  • active fibromyalgia, or

  • multiple sclerosis

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: LY3871801
Phase: 2
Study Start date:
May 23, 2023
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Medicina Reumatológica

    San Fernando, Buenos Aires 1646
    Argentina

    Active - Recruiting

  • Instituto de Alta Complejidad San Isidro

    San Isidro, Buenos Aires 1642
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Buenos Aires B2800DGH
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1061AAS
    Argentina

    Active - Recruiting

  • Mautalen Salud e Investigación

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1128AAF
    Argentina

    Active - Recruiting

  • CENUDIAB

    Ciudad Autónoma de Buenos Aire, C1440AAD
    Argentina

    Site Not Available

  • CENUDIAB

    Ciudad Autónoma de Buenos Aires, C1440AAD
    Argentina

    Active - Recruiting

  • A-Shine

    Plzen, Plzeň-měst 301 00
    Czechia

    Site Not Available

  • Clintrial s.r.o.

    Praha, Praha 10 100 00
    Czechia

    Site Not Available

  • Medical Plus

    Uherske Hradiste, Zlínský Kraj 686 01
    Czechia

    Active - Recruiting

  • CHU de Nice

    Nice, Alpes-Maritimes 06000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice, Alpes-Maritimes 06000
    France

    Site Not Available

  • CHU Strasbourg-Hautepierre

    Strasbourg, Alsace 67098
    France

    Active - Recruiting

  • Centre Hospitalier Regional D'Orleans

    Orléans, Centre 45067
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

    Reims, Champagne-Ardenne 51092
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard 30029
    France

    Active - Recruiting

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, Hérault 34295
    France

    Active - Recruiting

  • Infirmerie Protestante de Lyon

    Caluire et Cuire, Rhône 69300
    France

    Site Not Available

  • CHD Vendee

    La Roche-sur-Yon, Vendée 85000
    France

    Active - Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75679
    France

    Active - Recruiting

  • Fraunhofer

    Frankfurt, Hessen 60596
    Germany

    Active - Recruiting

  • Rheumazentrum Prof.Neeck MVZ

    Bad Doberan, Mecklenburg-Vorpommern 18209
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koeln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Completed

  • University Hospital of Cologne

    Köln, Nordrhein-Westfalen 50937
    Germany

    Active - Recruiting

  • Rheumazentrum Ratingen Studienambulanz

    Ratingen, Nordrhein-Westfalen 40878
    Germany

    Active - Recruiting

  • Institut für Präventive Medizin & Klinische Forschung GbR

    Magdeburg, Sachsen-Anhalt 39110
    Germany

    Active - Recruiting

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH

    Hamburg, 20095
    Germany

    Active - Recruiting

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T

    Hamburg, 20095
    Germany

    Completed

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / Dr. Andrea Everding GmbH GbR

    Hamburg, 20095
    Germany

    Site Not Available

  • CRU Hungary Kft.

    Encs, Borsod-Abaúj-Zemplén 3860
    Hungary

    Active - Recruiting

  • Regia Med Kft

    Szekesfehervar, Fejér 8000
    Hungary

    Active - Recruiting

  • Revita Clinic

    Budapest, Pest 1027
    Hungary

    Active - Recruiting

  • Kistarcsai Flor Ferenc Korhaz

    Kistarcsa, Pest 2143
    Hungary

    Active - Recruiting

  • Vital Medical Center

    Veszprem, Veszprém City 8200
    Hungary

    Site Not Available

  • Clinexpert Kft.

    Budapest, 1033
    Hungary

    Active - Recruiting

  • Óbudai Egészségügyi Centrum

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Vásárhelyi Sárkányfű KFT

    Hódmezővásárhely, 6800
    Hungary

    Active - Recruiting

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh 492099
    India

    Active - Recruiting

  • Avron Hospitals

    Ahmedabad, Gujarat 380013
    India

    Active - Recruiting

  • Sushruta Multispeciality Hospital & Research Centre

    Hubli, Karnataka 580021
    India

    Active - Recruiting

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, Maharashtra 441108
    India

    Active - Recruiting

  • Government Medical College And Hospital - Nagpur

    Nagpur, Maharashtra 440009
    India

    Active - Recruiting

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, Maharashtra 411001
    India

    Active - Recruiting

  • Medipoint Hospitals Pvt. Ltd.

    Pune, Maharashtra 411007
    India

    Active - Recruiting

  • CIMAB SA de CV

    Torreon, Coahuila 27000
    Mexico

    Active - Recruiting

  • Biológicos Especializados

    Mexico City, Distrito Federal 06700
    Mexico

    Active - Recruiting

  • Hospital Aranda de La Parra

    Leon, Guanajuato 37000
    Mexico

    Active - Recruiting

  • Cicmex Centro de Investigación Clínica de México

    Morelia, Michoacán 58020
    Mexico

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Active - Recruiting

  • Medical Care and Research SA de CV

    Merida, Yucatán 97070
    Mexico

    Active - Recruiting

  • Kohler and Milstein Research S.A. de C.V.

    Mérida, Yucatán 97070
    Mexico

    Active - Recruiting

  • Köhler & Milstein Research

    Mérida, Yucatán 97070
    Mexico

    Site Not Available

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua, 31000
    Mexico

    Active - Recruiting

  • Estudios Clínicos Internacionales (ECI) - Querétaro

    Querétaro, 76000
    Mexico

    Active - Recruiting

  • Centro de Atención e Investigación Cardiovascular del Potosí

    San Luis Potosí, 78200
    Mexico

    Active - Recruiting

  • Centrum Medyczne Reuma Park

    Warszawa, Mazowieckie 02-665
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa

    Warszawa, Mazowieckie 00-874
    Poland

    Active - Recruiting

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, Podlaskie 15-707
    Poland

    Active - Recruiting

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Białystok, Podlaskie 15-707
    Poland

    Site Not Available

  • Nzoz Bif-Med

    Bytom, Śląskie 41-902
    Poland

    Active - Recruiting

  • Cliniq s.r.o.

    Bratislava, Bratislavský Kraj 82119
    Slovakia

    Active - Recruiting

  • Russells Hall Hospital

    Dudley, England DY1 2HQ
    United Kingdom

    Site Not Available

  • The Dudley Group NHS Foundation Trust

    Dudley, England DY1 2HQ
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle upon Tyne, North Tyneside NE29 8NH
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Completed

  • Christine Thai, MD

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Center for Rheumatology Research

    Woodland Hills, California 91364
    United States

    Site Not Available

  • Integrity Clinical Research

    Doral, Florida 33122
    United States

    Site Not Available

  • Advanced Clinical Research of Orlando - Ocoee

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Encore Medical Research - Weston

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Bingham Memorial Hospital

    Blackfoot, Idaho 83221
    United States

    Active - Recruiting

  • Hinsdale Orthopaedics - Illinois Bone & Joint Institute

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York 11201
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Accellacare - Salisbury

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • PMG Research of Salisbury

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Overlake Arthritis and Osteoporosis Center

    Bellevue, Washington 98004
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.