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
- Diseases
- Rheumatoid arthritis
- 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
Sites (20)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale | Avondale | United States | Unknown status |
| Accurate Clinical Management, LLC | Baytown | United States | Unknown status |
| Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | United States | Unknown status |
| Medvin Clinical Research - Covina | Covina | United States | Unknown status |
| Altoona Center For Clinical Research | Duncansville | United States | Unknown status |
| Saint Paul Rheumatology | Eagan | United States | Unknown status |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff | Flagstaff | United States | Unknown status |
| Accurate Clinical Research, Inc | Houston | United States | Unknown status |
| Newport Huntington Medical Group | Huntington Beach | United States | Unknown status |
| Accurate Clinical Research, Inc | Lake Charles | United States | Unknown status |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa | Mesa | United States | Unknown status |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV | Phoenix | United States | Unknown status |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City | Sun City | United States | Unknown status |
| Clinical Research of West Florida | Tampa | United States | Unknown status |
| DM Clinical Research - TRA | Tomball | United States | Unknown status |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast | Tucson | United States | Unknown status |
| Medvin Clinical Research - Tujunga | Tujunga | United States | Unknown status |
| Medvin Clinical Research - Whittier | Whittier | United States | Unknown status |
| Willow Rheumatology and Wellness PLLC | Willowbrook | United States | Unknown status |
| Conquest Research | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.