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NCT06859294 | RECRUITING | Rheumatoid Arthritis

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

Eli Lilly and Company

Brief 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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

LY3541860

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2a, Single-Arm Study to Investigate the Efficacy and Safety of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
Actual Study Start Date : 2025-03-19
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis

Location Details

NCT06859294

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States, 85392

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States, 86001

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, United States, 85210

RECRUITING

United States, Arizona

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

Phoenix, Arizona, United States, 85032

RECRUITING

United States, Arizona

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

Sun City, Arizona, United States, 85351

RECRUITING

United States, Arizona

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

Tucson, Arizona, United States, 85748

RECRUITING

United States, California

Medvin Clinical Research - Covina

Covina, California, United States, 91722

RECRUITING

United States, California

Newport Huntington Medical Group

Huntington Beach, California, United States, 92648

NOT YET RECRUITING

United States, California

Stanford University Medical Center

Palo Alto, California, United States, 94304

RECRUITING

United States, California

Medvin Clinical Research - Tujunga

Tujunga, California, United States, 91042

RECRUITING

United States, California

Medvin Clinical Research - Whittier

Whittier, California, United States, 90602

RECRUITING

United States, Florida

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

Clinical Research of West Florida

Tampa, Florida, United States, 33606

RECRUITING

United States, Florida

Conquest Research

Winter Park, Florida, United States, 32789

RECRUITING

United States, Illinois

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States, 60527

RECRUITING

United States, Louisiana

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States, 70605

RECRUITING

United States, Minnesota

Saint Paul Rheumatology

Eagan, Minnesota, United States, 55121

RECRUITING

United States, Pennsylvania

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Texas

Accurate Clinical Management, LLC

Baytown, Texas, United States, 77521

RECRUITING

United States, Texas

Accurate Clinical Research, Inc

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

DM Clinical Research - TRA

Tomball, Texas, United States, 77375