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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: LY3541860

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Avondale, Arizona, United States, 85392
      • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
    • Flagstaff, Arizona, United States, 86001
      • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
    • Mesa, Arizona, United States, 85210
      • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
    • Phoenix, Arizona, United States, 85032
      • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
    • Sun City, Arizona, United States, 85351
      • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
    • Tucson, Arizona, United States, 85748
      • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research - Covina
    • Huntington Beach, California, United States, 92648
      • Newport Huntington Medical Group
    • Tujunga, California, United States, 91042
      • Medvin Clinical Research - Tujunga
    • Whittier, California, United States, 90602
      • Medvin Clinical Research - Whittier
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Illinois
    • Willowbrook, Illinois, United States, 60527
      • Willow Rheumatology and Wellness PLLC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Accurate Clinical Research, Inc
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Saint Paul Rheumatology
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • Texas
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Management, LLC
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research, Inc
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - TRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3541860; LY3541860 will be administered intravenously (IV).	Drug: LY3541860; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Synovitis Score	RAMRIS synovitis score ranges from 0-24, where a lower score indicates a lower level of inflammation.	Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 20	ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP.	Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 50	ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.	Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 70	ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.	Week 12
Change from Baseline in Disease Activity Score - Erythrocyte Sedimentation Rate (DAS28 - ESR)	DAS28-ESR measures disease activity in 28 joints using a composite numeric score. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.	Baseline, Week 12
Percentage of Participants Achieving Low disease activity (LDA) or Remission 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. The DAS28-hsCRP LDA is defined as DAS28-hsCRP ≤3.2.	Week 12
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good Response Criteria	EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-hsCRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. EULAR DAS28-hsCRP responder index defines good response criteria as change in DAS28-hSCRP > 1.2 from baseline with a new DAS28 score <=3.2.	Week 12
Change from Baseline in ACR Core Set Values Patient's Assessment of Arthritis Pain Using Visual Analog Scale (VAS)	Participants were asked to assess their current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain."	Baseline, Week 12
Change from Baseline in ACR Core Set Values Patient's Assessment of Physical Function Using Health Assessment Questionnaire - Disability Index (HAQ-DI)	Participants assess their degree of difficulty of physical function over the past week on a 4-item ordinal scale ranging from 0, "without any difficulty," to 3, "unable to do."	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): June 5, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: 27372; J3K-MC-KIAC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No