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Rheumatoid ArthritisPhase 2NCT06859294

A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis

A Phase 2 study testing LY3541860 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 20 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
LY3541860
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
20 sitesUnited States
Study dates
19 Mar 2025to 5 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

    Avondale, Arizona, 85392

  • Accurate Clinical Management, LLC

    Baytown, Texas, 77521

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Medvin Clinical Research - Covina

    Covina, California, 91722

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Saint Paul Rheumatology

    Eagan, Minnesota, 55121

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

    Flagstaff, Arizona, 86001

  • Accurate Clinical Research, Inc

    Houston, Texas, 77089

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana, 70605

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

    Mesa, Arizona, 85210

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

    Phoenix, Arizona, 85032

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

    Sun City, Arizona, 85351

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • DM Clinical Research - TRA

    Tomball, Texas, 77375

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

    Tucson, Arizona, 85748

  • Medvin Clinical Research - Tujunga

    Tujunga, California, 91042

  • Medvin Clinical Research - Whittier

    Whittier, California, 90602

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: 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.

Being tested
LY3541860
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3541860Drug

    Administered IV

Study groups in NCT06859294
Study groupRoleWhat they receive
LY3541860ExperimentalLY3541860 will be administered intravenously (IV).
Receives: Drug: LY3541860

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 12

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Week 12

  3. 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.

    Measured: Week 12

  4. 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.

    Measured: Week 12

  5. 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.

    Measured: Baseline, Week 12

  6. 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.

    Measured: Week 12

  7. 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.

    Measured: Week 12

  8. 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."

    Measured: Baseline, Week 12

  9. 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."

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completion10 Nov 2025
  4. Study completion5 Jun 2026

Why it stopped: The interim analysis data failed to demonstrate the intended treatment effect.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859294
Sponsor's protocol ID
27372
Other IDs
J3K-MC-KIAC
Status last verified
May 2026
First submitted
28 Feb 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3541860 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The interim analysis data failed to demonstrate the intended treatment effect.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Disease Activity Score - High-Sensitivity C-Reactive Protein (DAS28 - hsCRP) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06859294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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