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LY3041658

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Apr 28, 2023

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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04493502A Study of LY3041658 in Adults With Hidradenitis SuppurativaPHASE2 COMPLETED 72Aug 26, 2020Oct 13, 2022Apr 28, 202320 United States, Australia
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Week 16

The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules \[AN count\]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders.

Secondary Endpoints
Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
Baseline, Week 16
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
Baseline, Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3041658EXPERIMENTALParticipants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
PlaceboPLACEBO_COMPARATORPlacebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Interventions
NameTypeDescription
PlaceboDRUGAdministered IV
LY3041658DRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Have a diagnosis of HS for at least 6 months * Have HS lesions in at least 2 different anatomic areas * Have inadequate response or intolerance to a 28 day course of oral antibiotics * Have a total count of abscesses and inflammatory nodules greater than or equal to 4 * Agree ...

Countries:United StatesAustralia
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