A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
A Phase 2a, Single-Arm Study to Investigate the Efficacy and Safety of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
2 other identifiers
interventional
35
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Mar 2025
Shorter than P25 for phase_2 rheumatoid-arthritis
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 21, 2026
April 1, 2026
8 months
February 28, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Disease Activity Score - High-Sensitivity C-Reactive Protein (DAS28 - hsCRP)
DAS28-hsCRP measures disease activity in 28 joints using a composite numeric score. Total scores range from 1.0 to 9.4, where a lower score indicates less disease activity.
Baseline, Week 12
Secondary Outcomes (9)
Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Synovitis Score
Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 20
Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 50
Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 70
Week 12
Change from Baseline in Disease Activity Score - Erythrocyte Sedimentation Rate (DAS28 - ESR)
Baseline, Week 12
- +4 more secondary outcomes
Study Arms (1)
LY3541860
EXPERIMENTALLY3541860 will be administered intravenously (IV).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 5, 2025
Study Start
March 19, 2025
Primary Completion
November 10, 2025
Study Completion
May 1, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.