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Evaluating LY3541860 for treating active Rheumatoid Arthritis in adults

A Phase 2a, Single-Arm Study to Investigate the Efficacy and Safety of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis

Phase 2 Interventional Eli Lilly and Company · NCT06859294

This study is testing a new treatment called LY3541860 to see if it can help adults with moderate to severe rheumatoid arthritis who haven't had enough relief from other medications.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsrituximab
Locations20 sites (Avondale, Arizona and 19 other locations)
Trial IDNCT06859294 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy of LY3541860 in adults suffering from moderately to severely active Rheumatoid Arthritis who have not responded adequately to at least one biologic or targeted synthetic disease-modifying antirheumatic drug. Participants will undergo a 50-week study period, which includes a 6-week screening phase, a 24-week treatment phase, and a 20-week safety follow-up. The study will measure the impact of the treatment on joint swelling and tenderness, as well as MRI assessments of synovitis.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Rheumatoid Arthritis for at least three months and experiencing moderate to severe symptoms.

Not a fit: Patients with a recent history of malignancy or those who have not previously tried biologic or targeted synthetic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat Rheumatoid Arthritis.

How similar studies have performed: Other studies have shown promise with similar biologic therapies for Rheumatoid Arthritis, suggesting potential for success with this approach.

Eligibility criteria

Show full 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.

Where this trial is running

Avondale, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rheumatoid Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.