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ATI-50002

Phase 2

Vitiligo | Small molecule | Immunology |Aclaris Therapeutics, Inc.|Last Updated: Nov 30, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03468855A Study of ATI-50002 Topical Solution for the Treatment of VitiligoPHASE2 COMPLETED 34Mar 19, 2018Oct 16, 2019Nov 30, 20205 United States
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24
Baseline to 24 Weeks

Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

Secondary Endpoints
Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48
Baseline to 48 Weeks
Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4
Baseline to 4 Weeks
Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8
Baseline to 8 Weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATI-50002 Topical SolutionEXPERIMENTALATI-50002 topical solution, high dose active, twice-daily, 24 weeks
Interventions
NameTypeDescription
ATI-50002 topical solutionDRUGTopical Solution administered twice daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Subject has a clinical diagnosis of new onset or actively progressing non-segmental facial vitiligo or worsening of existing facial lesions within the past 6 months. 2. Subject has non-segmental facial vitiligo effecting at least 0.25% total body surface area (TBSA) (excludin...

Countries:United States
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