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LY3541860

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Apr 21, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06859294A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid ArthritisPHASE2 ACTIVE NOT_RECRUITING 35Mar 19, 2025May 1, 2026Apr 21, 202620 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in Disease Activity Score - High-Sensitivity C-Reactive Protein (DAS28 - hsCRP)
Baseline, Week 12

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.

Secondary Endpoints
Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Synovitis Score
Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 20
Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 50
Week 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3541860EXPERIMENTALLY3541860 will be administered intravenously (IV).
Interventions
NameTypeDescription
LY3541860DRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

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 *...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06859294primaryCompletionDate: changed
LOWMay 24, 2026NCT06859294studyFirstPostDate: changed