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ATI-1777

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Aclaris Therapeutics, Inc.|Last Updated: Sep 28, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

ATI-1777 · 1 trial · 1 indication

Phase 2 1
NCT04598269Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic DermatitisAtopic Dermatitis
COMPLETED50 Analytics
PHASE2COMPLETED
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

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 to 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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Frequently asked questions about ATI-1777

What is ATI-1777 used for?

ATI-1777 is an investigational small molecule being developed for the treatment of atopic dermatitis, a chronic inflammatory skin condition. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes ATI-1777?

ATI-1777 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company. Aclaris Therapeutics is publicly traded on the NASDAQ under the ticker symbol ACRS.

What phase is ATI-1777 in?

ATI-1777 is in Phase 2 clinical development. A Phase 2 study of ATI-1777 in adult patients with moderate or severe atopic dermatitis has been completed. The drug is investigational and has not been approved for any use.

What clinical trials is ATI-1777 in?

ATI-1777 has one completed Phase 2 clinical trial, identified as NCT04598269. This study evaluated ATI-1777 in adult patients with moderate or severe atopic dermatitis in the United States, enrolling 50 participants. The trial was randomized, double-blind, and placebo-controlled.

Is ATI-1777 FDA approved?

ATI-1777 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for atopic dermatitis. Further clinical development and regulatory review would be required before any approval could be considered.