ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-19

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06859294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

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)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, 85392

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, 86001

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, 85210

United States

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

Phoenix, Arizona, 85032

United States

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

Sun City, Arizona, 85351

United States

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

Tucson, Arizona, 85748

United States

Medvin Clinical Research - Covina

Covina, California, 91722

United States

Newport Huntington Medical Group

Huntington Beach, California, 92648

United States

Medvin Clinical Research - Tujunga

Tujunga, California, 91042

United States

Medvin Clinical Research - Whittier

Whittier, California, 90602

United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765

United States

Clinical Research of West Florida

Tampa, Florida, 33606

United States

Conquest Research

Winter Park, Florida, 32789

United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527

United States

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605

United States

Saint Paul Rheumatology

Eagan, Minnesota, 55121

United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

United States

Accurate Clinical Management, LLC

Baytown, Texas, 77521

United States

Accurate Clinical Research, Inc

Houston, Texas, 77089

United States

DM Clinical Research - TRA

Tomball, Texas, 77375

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-03-19

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Rheumatoid Arthritis