NCT05848258CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (actual)
- First submitted
- 28 Apr 2023
- Start date
- 23 May 2023
- Primary completion date
- 8 Dec 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05848258
- EU CT number
- 2022-502994-40-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 164
- From 23 May 2023 to the primary completion date, 8 Dec 2025
- 54 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Have Class IV RA according to ACR revised criteria
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (54)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CIPREC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CENUDIAB Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Medicina Reumatológica Coordinator of this site? Confirm its status | San Fernando | Argentina | Unknown status |
| Instituto de Alta Complejidad San Isidro Coordinator of this site? Confirm its status | San Isidro | Argentina | Unknown status |
| Medical Plus Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Unknown status |
| Universitaetsklinikum Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| CHU Montpellier Lapeyronie Hospital Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Centre Hospitalier Regional d Orleans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| Hopitaux Universitaires Paris Centre-Hopital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Strasbourg-Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hull Royal Infirmary Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Óbudai Egészségügyi Centrum Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Revita Clinic Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| CRU Hungary Kft. Coordinator of this site? Confirm its status | Encs | Hungary | Unknown status |
| Vasarhelyi Sarkanyfu Kft. Coordinator of this site? Confirm its status | Hódmezővásárhely | Hungary | Unknown status |
| Kistarcsai Flor Ferenc Korhaz Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Unknown status |
| Regia Med Kft Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Vital Medical Center Coordinator of this site? Confirm its status | Veszprém | Hungary | Unknown status |
| Avron Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Sushruta Multispeciality Hospital & Research Centre Coordinator of this site? Confirm its status | Hubli | India | Unknown status |
| All India Institute of Medical Sciences (AIIMS) - Nagpur Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Grant Medical Foundation Ruby Hall Clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Medipoint Hospitals Pvt. Ltd. Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Investigacion y Biomedicina de Chihuahua Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Hospital Aranda de la Parra Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
| Kohler and Milstein Research S.A. de C.V. Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Biológicos Especializados Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Cicmex Centro de Investigación Clínica de México Coordinator of this site? Confirm its status | Morelia | Mexico | Unknown status |
| Centro de Atención e Investigación Cardiovascular del Potosí Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| CIMAB SA de CV Coordinator of this site? Confirm its status | Torreón | Mexico | Unknown status |
| Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Nzoz Bif-Med Coordinator of this site? Confirm its status | Bytom | Poland | Unknown status |
| MICS Centrum Medyczne Warszawa Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centrum Medyczne Reuma Park Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Overlake Arthritis and Osteoporosis Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Joseph S. and Diane H. Steinberg Ambulatory Care Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Integrity Clinical Research Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| Accurate Clinical Research, Inc Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Newport Huntington Medical Group Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Accurate Clinical Research, Inc Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Advanced Clinical Research of Orlando - Ocoee Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Accellacare - Salisbury Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| Encore Medical Research - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Willow Rheumatology and Wellness PLLC Coordinator of this site? Confirm its status | Willowbrook | United States | Unknown status |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.