An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Completed · Phase 2 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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).
Key facts
- Study ID
- NCT05848258
- Run by
- Eli Lilly and Company
- People needed
- 164
- Starts
- 2023-05-23
- Expected to finish
- 2026-04-22
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- dermatomyositis
- active fibromyalgia, or
- multiple sclerosis
Where it is running
- 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
- Newport Huntington Medical Group — Huntington Beach, California, United States
Full record on ClinicalTrials.gov
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