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Eltrekibart

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Oct 16, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment352
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06046729A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis SuppurativaPHASE2 ACTIVE NOT_RECRUITING 352Oct 23, 2023Aug 1, 2026Oct 16, 202574 United States, Australia +4
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Study Endpoints
Primary Endpoints
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Week 16
Secondary Endpoints
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Baseline through Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Eltrekibart Dose 1EXPERIMENTALEltrekibart will be given subcutaneously (SC).
Eltrekibart Dose 2EXPERIMENTALEltrekibart will be given SC.
Eltrekibart Dose 3EXPERIMENTALEltrekibart will be given SC.
PlaceboPLACEBO_COMPARATORPlacebo will be given.
Interventions
NameTypeDescription
EltrekibartDRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites74

Inclusion Criteria: * Have a diagnosis of HS for at least 12 months. * Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III. * Have an (abscess plus inflammatory nodule) count of at least 5. * Agree to use topical antiseptics d...

Countries:United StatesAustraliaCanadaGermanyGreecePoland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06046729primaryCompletionDate: changed
LOWMay 24, 2026NCT06046729studyFirstPostDate: changed