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IDP-118 Vehicle

Phase 2

Psoriasis | Small molecule | Immunology |Bausch Health Companies Inc.|Last Updated: Aug 20, 2020

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02785172Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque PsoriasisPHASE2 COMPLETED 154Apr 1, 2016Jan 1, 2017Aug 20, 202014 United States
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Study Endpoints
Primary Endpoints
Percent of Subjects With Treatment Success
2 weeks

Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDP-118 LotionEXPERIMENTALLotion
Ultravate CreamACTIVE_COMPARATORCream
IDP-118 Vehicle LotionACTIVE_COMPARATORLotion
IDP-118 Vehicle CreamACTIVE_COMPARATORCream
Interventions
NameTypeDescription
IDP-118 Vehicle LotionDRUGVehicle
IDP-118 Vehicle CreamDRUGVehicle
IDP-118 LotionDRUGLotion
Ultravate CreamDRUGCream
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites14

Key Inclusion Criteria: * Male or female, of any race, at least 18 years of age (inclusive). * Freely provides both verbal and written informed consent. * Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA (Body Surface Area) of at least 3%, but no more than 12%. Th...

Countries:United States
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