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

NCT05848258 · Eli Lilly and Company
In plain English

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Official title
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
About this study
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 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 design
Enrollment target: 380 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-05-23
Estimated completion: 2026-07
Last updated: 2025-12-09
Interventions
Drug: LY3871801Drug: Placebo
Primary outcomes
  • Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) (Baseline, Week 12)
  • Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50 (Baseline to Week 12)
Sponsor
Eli Lilly and Company · industry
With: Rigel Pharmaceuticals
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (57)
Newport Huntington Medical GroupRecruiting
Huntington Beach, California, United States
Integrity Clinical ResearchActive Not Recruiting
Doral, Florida, United States
Advanced Clinical Research of Orlando - OcoeeActive Not Recruiting
Ocoee, Florida, United States
Encore Medical Research - WestonRecruiting
Weston, Florida, United States
Conquest ResearchRecruiting
Winter Park, Florida, United States
Willow Rheumatology and Wellness PLLCRecruiting
Willowbrook, Illinois, United States
Accurate Clinical Research, IncRecruiting
Lake Charles, Louisiana, United States
Joseph S. and Diane H. Steinberg Ambulatory Care CenterRecruiting
Brooklyn, New York, United States
Icahn School of Medicine at Mount SinaiSuspended
New York, New York, United States
Accellacare - SalisburyRecruiting
Salisbury, North Carolina, United States
Accurate Clinical Research, IncRecruiting
Houston, Texas, United States
Overlake Arthritis and Osteoporosis CenterNot Yet Recruiting
Bellevue, Washington, United States
CIPRECCompleted
Buenos Aires, Argentina
Mautalen Salud e InvestigaciónCompleted
Buenos Aires, Argentina
CENUDIABCompleted
Buenos Aires, Argentina
Medicina ReumatológicaCompleted
San Fernando, Argentina
Instituto de Alta Complejidad San IsidroCompleted
San Isidro, Argentina
Medical PlusRecruiting
Uherské Hradiště, Czechia
CHD VendeeRecruiting
La Roche-sur-Yon, France
CHU Montpellier Lapeyronie HospitalNot Yet Recruiting
Montpellier, France
CHU de NiceRecruiting
Nice, France
Centre Hospitalier Regional D'OrleansRecruiting
Orléans, France
Hopitaux Universitaires Paris Centre-Hopital CochinRecruiting
Paris, France
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison BlancheRecruiting
Reims, France
CHU Strasbourg-HautepierreRecruiting
Strasbourg, France
Universitaetsklinikum KoelnCompleted
Cologne, Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -TCompleted
Hamburg, Germany
Revita ClinicRecruiting
Budapest, Hungary
Clinexpert Kft.Recruiting
Budapest, Hungary
Óbudai Egészségügyi CentrumRecruiting
Budapest, Hungary
CRU Hungary Kft.Recruiting
Encs, Hungary
Vásárhelyi Sárkányfű KFTRecruiting
Hódmezővásárhely, Hungary
Kistarcsai Flor Ferenc KorhazRecruiting
Kistarcsa, Hungary
Regia Med KftRecruiting
Székesfehérvár, Hungary
Vital Medical CenterNot Yet Recruiting
Veszprém, Hungary
Avron HospitalsRecruiting
Ahmedabad, India
Sushruta Multispeciality Hospital & Research CentreRecruiting
Hubli, India
Government Medical College And Hospital - NagpurNot Yet Recruiting
Nagpur, India
All India Institute of Medical Sciences (AIIMS) - NagpurRecruiting
Nagpur, India
Grant Medical Foundation - Ruby Hall ClinicRecruiting
Pune, India
Medipoint Hospitals Pvt. Ltd.Recruiting
Pune, India
All India Institute of Medical SciencesRecruiting
Raipur, India
Investigacion y Biomedicina de ChihuahuaRecruiting
Chihuahua City, Mexico
Hospital Aranda de La ParraRecruiting
León, Mexico
Biológicos EspecializadosRecruiting
Mexico City, Mexico
Kohler and Milstein Research S.A. de C.V.Recruiting
Mérida, Mexico
Medical Care and Research SA de CVRecruiting
Mérida, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
Monterrey, Mexico
Cicmex Centro de Investigación Clínica de MéxicoRecruiting
Morelia, Mexico
Centro de Atención e Investigación Cardiovascular del PotosíRecruiting
San Luis Potosí City, Mexico
CIMAB SA de CVRecruiting
Torreón, Mexico
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i FizjoterapeutyRecruiting
Bialystok, Poland
Nzoz Bif-MedRecruiting
Bytom, Poland
MICS Centrum Medyczne WarszawaRecruiting
Warsaw, Poland
Centrum Medyczne Reuma ParkRecruiting
Warsaw, Poland
Hull Royal InfirmaryNot Yet Recruiting
Hull, United Kingdom
New Cross HospitalCompleted
Wolverhampton, United Kingdom
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis · TrialPath