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A-101 40

Phase 2

Common Warts | Small molecule | Other |Aclaris Therapeutics, Inc.|Last Updated: Dec 7, 2018

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment98
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02669862A Study of A-101 Solution in Subjects With Common Warts.PHASE2 COMPLETED 98Dec 21, 2015Sep 16, 2016Dec 7, 20181 United States
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Study Endpoints
Primary Endpoints
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
57 Days

The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.

Secondary Endpoints
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
visit 10 to visit 13
PWA Responder
Day 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A-101 Solution 40EXPERIMENTALA-101 Solution 40% administered once per week
A-101 Solution 45EXPERIMENTALA-101 Solution 45% administered once per week
Vehicle SolutionPLACEBO_COMPARATORVehicle Solution administered once per week
Interventions
NameTypeDescription
A-101 Solution 40DRUG -
A-101 Solution 45DRUG -
Vehicle SolutionDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject is at least 18 years of age 2. Subject has a clinical diagnosis of common warts 3. Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities: * Have a longest axis that is 3mm to 10mm * Have a thickness ≤3mm * Be a discrete lesion ...

Countries:United States
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