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A-101 Vehicle

Phase 2

Seborrheic Keratosis | Small molecule | Other |Aclaris Therapeutics, Inc.|Last Updated: Jan 3, 2019

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 Enrollment172
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02160626Dose-Response Profile of A-101 in Subjects With Seborrheic KeratosisPHASE2 COMPLETED 172Jun 1, 2014Dec 1, 2014Jan 3, 20195 United States
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Study Endpoints
Primary Endpoints
Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)
Baseline, visit 8

Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.

Secondary Endpoints
Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment
Baseline, visit 8
Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.
Baseline, visit 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A-101 VehiclePLACEBO_COMPARATORA-101 Vehicle (placebo) Topical Solution
A-101 (40) Topical SolutionACTIVE_COMPARATORA-101 (40) Topical Solution - high dose
A-101 (32.5) Topical SolutionACTIVE_COMPARATORA-101 (32.5) Topical Solution - low dose
Interventions
NameTypeDescription
A-101 VehicleDRUGPlacebo control
A-101 (40) Topical SolutionDRUGA-101 (40) Topical Solution - high dose
A-101 (32.5) Topical SolutionDRUGA-101 (32.5) Topical Solution - low dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Subject is at least 18 years of age 2. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis 3. Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities: * Have a clinically typical appearance ...

Countries:United States
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