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ATI-1777

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Aclaris Therapeutics, Inc.|Last Updated: Sep 28, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04598269Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic DermatitisPHASE2 COMPLETED 50Sep 30, 2020Apr 22, 2021Sep 28, 202314 United States
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4
Baseline, Week 4

The EASI evaluation was performed by the Principal Investigator and evaluated atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores ranged from 0-72, with higher scores indicative of more severe disease.

Secondary Endpoints
Percent Change From Baseline in EASI Score at Days 8 and 15
Baseline, Days 8 and 15
Number of Participants Who Achieve 50% Improvement in EASI Score (EASI 50) by Week 4
Week 4
Number of Participants Who Achieve 75% Improvement in EASI Score (EASI-75) by Week 4
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATI-1777EXPERIMENTALATI-1777 topical solution 2.0% w/w, twice daily
VehiclePLACEBO_COMPARATORVehicle topical solution, twice daily
Interventions
NameTypeDescription
ATI-1777DRUGATI-1777 topical solution 2.0% w/w
VehicleDRUGVehicle topical solution containing no ATI-1777
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Able to comprehend and willing to sign the IRB approved informed consent form (ICF) prior to administration of study-related procedures. 2. Male patients or non-pregnant, non-nursing female patients 18 to 65 years old, inclusive, at the time of informed consent. 3. Pregnancy ...

Countries:United States
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