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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06859294
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3541860

LY3541860 will be administered intravenously (IV).

Interventions

Drug: - LY3541860

Administered IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Flagstaff, Arizona

Status

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, 86001

Mesa, Arizona

Status

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, 85210

Phoenix, Arizona

Status

Address

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

Phoenix, Arizona, 85032

Phoenix, Arizona

Status

Address

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

Phoenix, Arizona, 85037

Sun City, Arizona

Status

Address

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

Sun City, Arizona, 85351

Tucson, Arizona

Status

Address

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

Tucson, Arizona, 85748

Medvin Clinical Research - Covina, Covina, California

Status

Address

Medvin Clinical Research - Covina

Covina, California, 91722

Newport Huntington Medical Group, Huntington Beach, California

Status

Address

Newport Huntington Medical Group

Huntington Beach, California, 92648

Medvin Clinical Research - Tujunga, Tujunga, California

Status

Address

Medvin Clinical Research - Tujunga

Tujunga, California, 91042

Medvin Clinical Research - Whittier, Whittier, California

Status

Address

Medvin Clinical Research - Whittier

Whittier, California, 90602

Clearwater, Florida

Status

Address

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765

Clinical Research of West Florida, Tampa, Florida

Status

Address

Clinical Research of West Florida

Tampa, Florida, 33606

Conquest Research, Winter Park, Florida

Status

Address

Conquest Research

Winter Park, Florida, 32789

Willow Rheumatology and Wellness PLLC, Willowbrook, Illinois

Status

Address

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527

Accurate Clinical Research, Inc, Lake Charles, Louisiana

Status

Address

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605

Saint Paul Rheumatology, Eagan, Minnesota

Status

Address

Saint Paul Rheumatology

Eagan, Minnesota, 55121

University of Rochester Medical Center, Rochester, New York

Status

Address

University of Rochester Medical Center

Rochester, New York, 14642

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Accurate Clinical Management, LLC, Baytown, Texas

Status

Address

Accurate Clinical Management, LLC

Baytown, Texas, 77521

Accurate Clinical Research, Inc, Houston, Texas

Status

Address

Accurate Clinical Research, Inc

Houston, Texas, 77089

DM Clinical Research - TRA, Tomball, Texas

Status

Address

DM Clinical Research - TRA

Tomball, Texas, 77375