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NCT06859294TerminatedPhase 2

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

Source: ClinicalTrials.gov · Last updated 17 Jun 2026

Reason given: The interim analysis data failed to demonstrate the intended treatment effect.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (actual)
First submitted
28 Feb 2025
Start date
19 Mar 2025
Primary completion date
10 Nov 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT06859294

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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 a current or recent active infection.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - AvondaleAvondaleUnited StatesUnknown status
Accurate Clinical Management, LLCBaytownUnited StatesUnknown status
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterUnited StatesUnknown status
Medvin Clinical Research - CovinaCovinaUnited StatesUnknown status
Altoona Center For Clinical ResearchDuncansvilleUnited StatesUnknown status
Saint Paul RheumatologyEaganUnited StatesUnknown status
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - FlagstaffFlagstaffUnited StatesUnknown status
Accurate Clinical Research, IncHoustonUnited StatesUnknown status
Newport Huntington Medical GroupHuntington BeachUnited StatesUnknown status
Accurate Clinical Research, IncLake CharlesUnited StatesUnknown status
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - MesaMesaUnited StatesUnknown status
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PVPhoenixUnited StatesUnknown status
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun CitySun CityUnited StatesUnknown status
Clinical Research of West FloridaTampaUnited StatesUnknown status
DM Clinical Research - TRATomballUnited StatesUnknown status
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson SoutheastTucsonUnited StatesUnknown status
Medvin Clinical Research - TujungaTujungaUnited StatesUnknown status
Medvin Clinical Research - WhittierWhittierUnited StatesUnknown status
Willow Rheumatology and Wellness PLLCWillowbrookUnited StatesUnknown status
Conquest ResearchWinter ParkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.