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ATI-045

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Aclaris Therapeutics, Inc.|Last Updated: Mar 25, 2026

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 Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07011706ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic DermatitisPHASE2 ACTIVE NOT_RECRUITING 110May 30, 2025Oct 1, 2026Mar 25, 202660 United States, Canada
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Study Endpoints
Primary Endpoints
Percent Change in Eczema Area and Severity Index (EASI)
Baseline to Week 24

Percent change from baseline in EASI score at Week 24

Secondary Endpoints
Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Baseline to Week 24
EASI reduction
Baseline to Week 24
Peak Pruritus Numerical Rating Scale (PP-NRS) score
Baseline to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATI-045 groupEXPERIMENTALATI-045 group
Placebo groupPLACEBO_COMPARATORPlacebo group
Interventions
NameTypeDescription
ATI-045DRUGATI-045 group
PlaceboDRUGPlacebo group
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening * Have active moderate to severe AD at screening and baseline visits * EASI score ≥ 16 and ≥10% BSA...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07011706Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07011706studyFirstPostDate: changed