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

Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Newport Huntington Medical Group
RECRUITING
Huntington Beach
Florida
Integrity Clinical Research
ACTIVE_NOT_RECRUITING
Doral
Advanced Clinical Research of Orlando - Ocoee
ACTIVE_NOT_RECRUITING
Ocoee
Encore Medical Research - Weston
RECRUITING
Weston
Conquest Research
RECRUITING
Winter Park
Illinois
Willow Rheumatology and Wellness PLLC
RECRUITING
Willowbrook
Louisiana
Accurate Clinical Research, Inc
RECRUITING
Lake Charles
North Carolina
Accellacare - Salisbury
RECRUITING
Salisbury
New York
Joseph S. and Diane H. Steinberg Ambulatory Care Center
RECRUITING
Brooklyn
Icahn School of Medicine at Mount Sinai
SUSPENDED
New York
Texas
Accurate Clinical Research, Inc
RECRUITING
Houston
Washington
Overlake Arthritis and Osteoporosis Center
NOT_YET_RECRUITING
Bellevue
Other Locations
Argentina
CENUDIAB
COMPLETED
Buenos Aires
CIPREC
COMPLETED
Buenos Aires
Mautalen Salud e Investigación
COMPLETED
Buenos Aires
Medicina Reumatológica
COMPLETED
San Fernando
Instituto de Alta Complejidad San Isidro
COMPLETED
San Isidro
France
CHD Vendee
RECRUITING
La Roche-sur-yon
CHU Montpellier Lapeyronie Hospital
NOT_YET_RECRUITING
Montpellier
CHU de Nice
RECRUITING
Nice
Centre Hospitalier Regional D'Orleans
RECRUITING
Orléans
Hopitaux Universitaires Paris Centre-Hopital Cochin
RECRUITING
Paris
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
RECRUITING
Reims
CHU Strasbourg-Hautepierre
RECRUITING
Strasbourg
Germany
Universitaetsklinikum Koeln
COMPLETED
Cologne
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
COMPLETED
Hamburg
Hungary
Clinexpert Kft.
RECRUITING
Budapest
Óbudai Egészségügyi Centrum
RECRUITING
Budapest
Revita Clinic
RECRUITING
Budapest
CRU Hungary Kft.
RECRUITING
Encs
Vásárhelyi Sárkányfű KFT
RECRUITING
Hódmezővásárhely
Kistarcsai Flor Ferenc Korhaz
RECRUITING
Kistarcsa
Regia Med Kft
RECRUITING
Székesfehérvár
Vital Medical Center
NOT_YET_RECRUITING
Veszprém
India
Avron Hospitals
RECRUITING
Ahmedabad
Sushruta Multispeciality Hospital & Research Centre
RECRUITING
Hubli
All India Institute of Medical Sciences (AIIMS) - Nagpur
RECRUITING
Nagpur
Government Medical College And Hospital - Nagpur
NOT_YET_RECRUITING
Nagpur
Grant Medical Foundation - Ruby Hall Clinic
RECRUITING
Pune
Medipoint Hospitals Pvt. Ltd.
RECRUITING
Pune
All India Institute of Medical Sciences
RECRUITING
Raipur
Mexico
Investigacion y Biomedicina de Chihuahua
RECRUITING
Chihuahua City
Hospital Aranda de La Parra
RECRUITING
León
Kohler and Milstein Research S.A. de C.V.
RECRUITING
Mérida
Medical Care and Research SA de CV
RECRUITING
Mérida
Biológicos Especializados
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Cicmex Centro de Investigación Clínica de México
RECRUITING
Morelia
Centro de Atención e Investigación Cardiovascular del Potosí
RECRUITING
San Luis Potosí City
CIMAB SA de CV
RECRUITING
Torreón
Poland
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
RECRUITING
Bialystok
Nzoz Bif-Med
RECRUITING
Bytom
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
United Kingdom
Hull Royal Infirmary
NOT_YET_RECRUITING
Hull
New Cross Hospital
COMPLETED
Wolverhampton
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-07
Participants
Target number of participants: 380
Treatments
Experimental: LY3871801 Phase 2a
Participants will receive LY3871801 administered orally.
Placebo_comparator: Placebo Phase 2a
Participants will receive placebo.
Experimental: LY3871801 Dose 1 Phase 2b
Participants will receive LY3871801 administered orally.
Experimental: LY3871801 Dose 2 Phase 2b
Participants will receive LY3871801 administered orally.
Experimental: LY3871801 Dose 3 Phase 2b
Participants will receive LY3871801 administered orally.
Placebo_comparator: Placebo Phase 2b
Participants will receive placebo.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company
Collaborators: Rigel Pharmaceuticals

This content was sourced from clinicaltrials.gov