Clinical trial NCT06859294: A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Study participation is approximately 50 weeks, including a 6-week screening period, 24-week treatment period, and a 20-week safety follow up period.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Disease Activity Score - High-Sensitivity C-Reactive Protein (DAS28 - hsCRP)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Synovitis Score
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20
timeFrame: Week 12
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 50
timeFrame: Week 12
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 70
timeFrame: Week 12
measure: Change from Baseline in Disease Activity Score - Erythrocyte Sedimentation Rate (DAS28 - ESR)
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
timeFrame: Week 12
measure: Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good Response Criteria
timeFrame: Week 12
measure: Change from Baseline in ACR Core Set Values Patient's Assessment of Arthritis Pain Using Visual Analog Scale (VAS)
timeFrame: Baseline, Week 12
measure: Change from Baseline in ACR Core Set Values Patient's Assessment of Physical Function Using Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Avondale
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
state: Arizona
city: Flagstaff
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
state: Arizona
city: Mesa
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
state: Arizona
city: Phoenix
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
state: Arizona
city: Sun City
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
state: Arizona
city: Tucson
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research - Covina
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research - Tujunga
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Whittier
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness PLLC
state: Illinois
city: Lake Charles
country: United States
facility: Accurate Clinical Research, Inc
state: Louisiana
city: Eagan
country: United States
facility: Saint Paul Rheumatology
state: Minnesota
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Baytown
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - TRA
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: