A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis

Stopped early · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

The main purpose of this study is to evaluate the effects of LY3541860 in adult participants with moderately to severely active Rheumatoid Arthritis with inadequate response to a least one biologic disease-modifying antirheumatic drug (bDMARD)or targeted synthetic disease-modifying antirheumatic drug (tsDMARD). Study participation is approximately 50 weeks, including a 6-week screening period, 24-week treatment period, and a 20-week safety follow up period.

Key facts

Study ID

NCT06859294

Run by

Eli Lilly and Company

People needed

35

Starts

2025-03-19

Expected to finish

2026-06-05

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/EULAR classification criteria.
• Have moderately to severely active RA, at screening (Visit 1) and baseline (Visit 2), defined by the presence of
• ≥6 swollen joints based on 66 joint count (and ≥4 swollen joints on 28 joint count), and
• ≥6 tender joints based on 68 joint count (and ≥4 tender joints on 28 joint count).
• Have active synovitis in ≥1 joint, in hands or wrists, of the investigator choosing at screening, having an MRI synovitis RAMRIS score of ≥2 as determined from the central reading of the images.

You may not qualify if…

• Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of
• basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
• cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.
• Have estimated glomerular filtration rate (eGFR) of <45 milliliter per minute (mL/minute) from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
• Have a current or recent active infection.
• 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 3a or b, 4, or 5
• symptomatic heart failure according to New York Heart Association Class 2, 3, or 4
• myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before baseline
• 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
• Have received any prior B-cell targeted therapy (for example, anti-CD19 antibodies or anti-CD20 antibodies, such as rituximab).
• Received corticosteroids, opioids, conventional disease-modifying antirheumatic drug (cDMARD), with changes in dose or have received Janus kinase (JAK) inhibitors within 28 days prior to the screening MRI or plan on receiving these drugs during the study.

Where it is running

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff — Flagstaff, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa — Mesa, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV — Phoenix, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City — Sun City, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast — Tucson, Arizona, United States
• Medvin Clinical Research - Covina — Covina, California, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• Medvin Clinical Research - Tujunga — Tujunga, California, United States
• Medvin Clinical Research - Whittier — Whittier, California, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• Clinical Research of West Florida — Tampa, 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
• Saint Paul Rheumatology — Eagan, Minnesota, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Accurate Clinical Management, LLC — Baytown, Texas, United States
• Accurate Clinical Research, Inc — Houston, Texas, United States
• DM Clinical Research - TRA — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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