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

Launched by ELI LILLY AND COMPANY · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LY3541860 to see how it helps adults with moderately to severely active rheumatoid arthritis (RA) who have not responded well to at least one previous treatment. The trial aims to find out if this medication can improve symptoms and overall health in participants. It is designed for adults aged 18 and older who have been diagnosed with RA for at least three months and have specific signs of active disease, such as swollen and tender joints.

If you or someone you know is interested in participating, the study will last about 50 weeks, which includes a 6-week screening period to determine eligibility, a 24-week treatment phase where participants will receive the study medication, and a 20-week follow-up to monitor safety. However, there are certain criteria to keep in mind; for example, participants should not have serious heart or kidney issues or certain other medical conditions. This trial is currently recruiting participants, and it's a chance to contribute to research that could help improve treatments for rheumatoid arthritis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.