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IDP-124

Phase 3

Atopic Dermatitis | Small molecule | Immunology |Bausch Health Companies Inc.|Last Updated: May 8, 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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment666
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03058783Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult SubjectsPHASE3 COMPLETED 328Aug 14, 2018May 12, 2020May 8, 20231 United States
NCT03002571Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)PHASE3 COMPLETED 338Jul 24, 2018Apr 14, 2020May 8, 20231 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear"
Baseline to Week 6

Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.

Secondary Endpoints
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"
Baseline to Week 10
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Baseline to Week 10
Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild"
Baseline to Week 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDP-124 LotionEXPERIMENTALIDP-124 Lotion, twice-daily application
IDP-124 Vehicle LotionACTIVE_COMPARATORIDP-124 Vehicle Lotion, twice-daily application
Interventions
NameTypeDescription
IDP-124 LotionDRUGIDP-124 Lotion, twice-daily application
IDP-124 Vehicle LotionDRUGIDP-124 Vehicle Lotion, twice-daily application
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female at least 2 years of age and older * Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent durin...

Countries:United States
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