A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
NCT ID: NCT06859294
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2025-03-19
2026-09-30
Brief Summary
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Study participation is approximately 50 weeks, including a 6-week screening period, 24-week treatment period, and a 20-week safety follow up period.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LY3541860
LY3541860 will be administered intravenously (IV).
LY3541860
Administered IV
Interventions
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LY3541860
Administered IV
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Related Links
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Related Info
Other Identifiers
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J3K-MC-KIAC
Identifier Type: OTHER
Identifier Source: secondary_id
27372
Identifier Type: -
Identifier Source: org_study_id
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