An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
3 other identifiers
interventional
164
10 countries
54
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started May 2023
Longer than P75 for phase_2 rheumatoid-arthritis
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedApril 23, 2026
April 1, 2026
2.5 years
April 28, 2023
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (15)
Phase 2a: Percentage of Participants Achieving ACR20/50/70
Baseline to Week 12
Phase 2b: Change from Baseline in DAS28-hsCRP
Baseline, Week 12
Phase 2b: Percentage of Participants Achieving ACR20/70
Week 12
Change from Baseline in Simplified Disease Activity Index (SDAI)
Baseline, Week 12
Change from Baseline in Clinical Disease Activity Index (CDAI)
Baseline, Week 12
- +10 more secondary outcomes
Study Arms (6)
LY3871801 Phase 2a
EXPERIMENTALParticipants will receive LY3871801 administered orally.
Placebo Phase 2a
PLACEBO COMPARATORParticipants will receive placebo.
LY3871801 Dose 1 Phase 2b
EXPERIMENTALParticipants will receive LY3871801 administered orally.
LY3871801 Dose 2 Phase 2b
EXPERIMENTALParticipants will receive LY3871801 administered orally.
LY3871801 Dose 3 Phase 2b
EXPERIMENTALParticipants will receive LY3871801 administered orally.
Placebo Phase 2b
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigel Pharmaceuticalscollaborator
- Eli Lilly and Companylead
Study Sites (54)
Newport Huntington Medical Group
Huntington Beach, California, 92648, United States
Integrity Clinical Research
Doral, Florida, 33122, United States
Advanced Clinical Research of Orlando - Ocoee
Ocoee, Florida, 34761, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Conquest Research
Winter Park, Florida, 32789, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527, United States
Accurate Clinical Research, Inc
Lake Charles, Louisiana, 70605, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Accellacare - Salisbury
Salisbury, North Carolina, 28144, United States
Accurate Clinical Research, Inc
Houston, Texas, 77089, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, 98004, United States
CIPREC
Buenos Aires, C1061AAS, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
CENUDIAB
Buenos Aires, C1440AAD, Argentina
Medicina Reumatológica
San Fernando, 1646, Argentina
Instituto de Alta Complejidad San Isidro
San Isidro, 1642, Argentina
Medical Plus
Uherské Hradiště, 686 01, Czechia
CHD Vendee
La Roche-sur-Yon, 85000, France
CHU Montpellier Lapeyronie Hospital
Montpellier, 34295, France
CHU de Nice
Nice, 06000, France
Centre Hospitalier Regional D'Orleans
Orléans, 45067, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75679, France
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims, 51092, France
CHU Strasbourg-Hautepierre
Strasbourg, 67098, France
Universitaetsklinikum Koeln
Cologne, 50937, Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg, 20095, Germany
Revita Clinic
Budapest, 1027, Hungary
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
CRU Hungary Kft.
Encs, 3860, Hungary
Vásárhelyi Sárkányfű KFT
Hódmezővásárhely, 6800, Hungary
Kistarcsai Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Regia Med Kft
Székesfehérvár, 8000, Hungary
Vital Medical Center
Veszprém, 8200, Hungary
Avron Hospitals
Ahmedabad, 380013, India
Sushruta Multispeciality Hospital & Research Centre
Hubli, 580021, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, 441108, India
Grant Medical Foundation - Ruby Hall Clinic
Pune, 411001, India
Medipoint Hospitals Pvt. Ltd.
Pune, 411007, India
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Hospital Aranda de La Parra
León, 37000, Mexico
Biológicos Especializados
Mexico City, 06700, Mexico
Kohler and Milstein Research S.A. de C.V.
Mérida, 97070, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 66460, Mexico
Cicmex Centro de Investigación Clínica de México
Morelia, 58020, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí
San Luis Potosí City, 78200, Mexico
CIMAB SA de CV
Torreón, 27000, Mexico
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, 15-707, Poland
Nzoz Bif-Med
Bytom, 41-902, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Centrum Medyczne Reuma Park
Warsaw, 02-665, Poland
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 8, 2023
Study Start
May 23, 2023
Primary Completion
December 8, 2025
Study Completion
April 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.