An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
NCT ID: NCT05848258
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
380 participants
INTERVENTIONAL
2023-05-23
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3871801 Phase 2a
Participants will receive LY3871801 administered orally.
LY3871801
Administered orally
Placebo Phase 2a
Participants will receive placebo.
Placebo
Administered orally
LY3871801 Dose 1 Phase 2b
Participants will receive LY3871801 administered orally.
LY3871801
Administered orally
LY3871801 Dose 2 Phase 2b
Participants will receive LY3871801 administered orally.
LY3871801
Administered orally
LY3871801 Dose 3 Phase 2b
Participants will receive LY3871801 administered orally.
LY3871801
Administered orally
Placebo Phase 2b
Participants will receive placebo.
Placebo
Administered orally
Interventions
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LY3871801
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
CHU de Nice
Nice, , France
Centre Hospitalier Regional D'Orleans
Orléans, , France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, , France
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims, , France
CHU Strasbourg-Hautepierre
Strasbourg, , France
Universitaetsklinikum Koeln
Cologne, , Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg, , Germany
Revita Clinic
Budapest, , Hungary
Clinexpert Kft.
Budapest, , Hungary
Óbudai Egészségügyi Centrum
Budapest, , Hungary
CRU Hungary Kft.
Encs, , Hungary
Vásárhelyi Sárkányfű KFT
Hódmezővásárhely, , Hungary
Kistarcsai Flor Ferenc Korhaz
Kistarcsa, , Hungary
Regia Med Kft
Székesfehérvár, , Hungary
Vital Medical Center
Veszprém, , Hungary
Avron Hospitals
Ahmedabad, , India
Sushruta Multispeciality Hospital & Research Centre
Hubli, , India
Government Medical College And Hospital - Nagpur
Nagpur, , India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, , India
Grant Medical Foundation - Ruby Hall Clinic
Pune, , India
Medipoint Hospitals Pvt. Ltd.
Pune, , India
All India Institute of Medical Sciences
Raipur, , India
Investigacion y Biomedicina de Chihuahua
Chihuahua City, , Mexico
Hospital Aranda de La Parra
León, , Mexico
Biológicos Especializados
Mexico City, , Mexico
Kohler and Milstein Research S.A. de C.V.
Mérida, , Mexico
Medical Care and Research SA de CV
Mérida, , Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, , Mexico
Cicmex Centro de Investigación Clínica de México
Morelia, , Mexico
Centro de Atención e Investigación Cardiovascular del Potosí
San Luis Potosí City, , Mexico
CIMAB SA de CV
Torreón, , Mexico
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, , Poland
Nzoz Bif-Med
Bytom, , Poland
MICS Centrum Medyczne Warszawa
Warsaw, , Poland
Centrum Medyczne Reuma Park
Warsaw, , Poland
Hull Royal Infirmary
Hull, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Related Links
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An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Other Identifiers
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J3P-MC-FTAF
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502994-40-00
Identifier Type: OTHER
Identifier Source: secondary_id
18516
Identifier Type: -
Identifier Source: org_study_id
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