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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Treatment

LY3541860

Clinical Study ID

NCT06859294
27372
J3K-MC-KIAC
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) for at least 3 monthsprior 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 jointcount), and

  • ≥6 tender joints based on 68 joint count (and ≥4 tender joints on 28 jointcount).

  • Have active synovitis in ≥1 joint, in hands or wrists, of the investigator choosingat screening, having an MRI synovitis RAMRIS score of ≥2 as determined from thecentral reading of the images.

Exclusion

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 beenresected with no evidence of metastatic disease for 3 years, or

  • cervical carcinoma in situ, with no evidence of recurrence within the 5 yearsprior to baseline.

  • Have estimated glomerular filtration rate (eGFR) of <45 milliliter per minute (mL/minute) from serum creatinine using the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation.

  • Have a current or recent active infection.

  • Have presence of 1 or more significant concurrent medical conditions perinvestigator 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 ischemicattack within the past 12 months before baseline

  • severe chronic pulmonary disease, for example, requiring oxygen therapy majorchronic 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-radiographicaxial spondyloarthritis

  • reactive arthritis

  • gout

  • scleroderma

  • polymyositis

  • dermatomyositis

  • active fibromyalgia, or

  • multiple sclerosis

  • Have received any prior B-cell targeted therapy (for example, anti-CD19 antibodiesor 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 thestudy.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: LY3541860
Phase: 2
Study Start date:
March 19, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

    Avondale, Arizona 85392
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix West

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

    Tucson, Arizona 85748
    United States

    Active - Recruiting

  • Medvin Clinical Research - Covina

    Covina, California 91722
    United States

    Active - Recruiting

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Medvin Clinical Research - Tujunga

    Tujunga, California 91042
    United States

    Active - Recruiting

  • Medvin Clinical Research - Whittier

    Whittier, California 90602
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Saint Paul Rheumatology

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Accurate Clinical Management, LLC

    Baytown, Texas 77521
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc

    Houston, Texas 77089
    United States

    Active - Recruiting

  • DM Clinical Research - TRA

    Tomball, Texas 77375
    United States

    Active - Recruiting

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