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 8 AM - 8 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 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.

Avondale 5552301, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale 5552301, Arizona 5551752, 85392

Flagstaff 5294810, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff 5294810, Arizona 5551752, 86001

Mesa 5304391, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa 5304391, Arizona 5551752, 85210

Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

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

Phoenix 5308655, Arizona 5551752, 85032

Sun City 5316201, Arizona 5551752

Status

Recruiting

Address

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

Sun City 5316201, Arizona 5551752, 85351

Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

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

Tucson 5318313, Arizona 5551752, 85748

Medvin Clinical Research - Covina, Covina 5340175, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Covina

Covina 5340175, California 5332921, 91722

Newport Huntington Medical Group, Huntington Beach 5358705, California 5332921

Status

Recruiting

Address

Newport Huntington Medical Group

Huntington Beach 5358705, California 5332921, 92648

Stanford University Medical Center, Palo Alto 5380748, California 5332921

Status

Not yet recruiting

Address

Stanford University Medical Center

Palo Alto 5380748, California 5332921, 94304

Medvin Clinical Research - Tujunga, Tujunga 5403767, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Tujunga

Tujunga 5403767, California 5332921, 91042

Medvin Clinical Research - Whittier, Whittier 5409059, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Whittier

Whittier 5409059, California 5332921, 90602

Clearwater 4151316, Florida 4155751

Status

Recruiting

Address

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater 4151316, Florida 4155751, 33765

Clinical Research of West Florida, Tampa 4174757, Florida 4155751

Status

Recruiting

Address

Clinical Research of West Florida

Tampa 4174757, Florida 4155751, 33606

Conquest Research, Winter Park 4178560, Florida 4155751

Status

Recruiting

Address

Conquest Research

Winter Park 4178560, Florida 4155751, 32789

Willow Rheumatology and Wellness PLLC, Willowbrook 4916709, Illinois 4896861

Status

Recruiting

Address

Willow Rheumatology and Wellness PLLC

Willowbrook 4916709, Illinois 4896861, 60527

Accurate Clinical Research, Inc, Lake Charles 4330236, Louisiana 4331987

Status

Recruiting

Address

Accurate Clinical Research, Inc

Lake Charles 4330236, Louisiana 4331987, 70605

Saint Paul Rheumatology, Eagan 5024825, Minnesota 5037779

Status

Recruiting

Address

Saint Paul Rheumatology

Eagan 5024825, Minnesota 5037779, 55121

Altoona Center For Clinical Research, Duncansville 5187508, Pennsylvania 6254927

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville 5187508, Pennsylvania 6254927, 16635

Accurate Clinical Management, LLC, Baytown 4672731, Texas 4736286

Status

Recruiting

Address

Accurate Clinical Management, LLC

Baytown 4672731, Texas 4736286, 77521

Accurate Clinical Research, Inc, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Accurate Clinical Research, Inc

Houston 4699066, Texas 4736286, 77089

DM Clinical Research - TRA, Tomball 4737094, Texas 4736286

Status

Recruiting

Address

DM Clinical Research - TRA

Tomball 4737094, Texas 4736286, 77375