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IDP-122 Vehicle

Phase 2

Psoriasis | Small molecule | Immunology |Bausch Health Companies Inc.|Last Updated: Aug 27, 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 Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02785185Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque PsoriasisPHASE2 COMPLETED 150Jun 1, 2016Jan 1, 2017Aug 27, 202013 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2
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" at Week 2. 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-122 LotionEXPERIMENTALLotion
Ultravate CreamACTIVE_COMPARATORCream
IDP-122 Vehicle LotionACTIVE_COMPARATORLotion
IDP-122 Vehicle CreamACTIVE_COMPARATORCream
Interventions
NameTypeDescription
IDP-122 Vehicle LotionDRUGVehicle
IDP-122 Vehicle CreamDRUGVehicle
IDP-122 LotionDRUGLotion
Ultravate CreamDRUGCream
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites13

Key Inclusion Criteria: * Male or female, of any race, at least 18 years of age (inclusive). * Freely provides both verbal and written informed consent. * Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the ...

Countries:United States
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