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ATI-1777

Phase 2

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

ATI-1777 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2020

ATI-1777 target and mechanism

Molecular targetJAK1/JAK3
Target classKinase
ModalitySmall molecule

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

ATI-1777 clinical trials

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
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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 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?

ATI-1777 is an investigational small molecule being developed by Aclaris Therapeutics, Inc. for the treatment of atopic dermatitis. It is a topical kinase inhibitor that targets JAK1 and JAK3. ATI-1777 has completed a Phase 2 clinical trial in adults with moderate or severe atopic dermatitis.

What is ATI-1777 used for?

ATI-1777 is being developed for the treatment of atopic dermatitis, a chronic inflammatory skin condition. The clinical program has focused on adult patients with moderate or severe forms of the disease. It remains investigational and has not been approved for commercial use.

What does ATI-1777 target?

ATI-1777 targets JAK1 and JAK3, two members of the Janus kinase family of enzymes. These kinases are part of the JAK-STAT signaling pathway, which transmits cytokine signals involved in inflammation. By inhibiting JAK1 and JAK3, ATI-1777 is designed to reduce inflammatory signaling in the skin.

Who is developing ATI-1777?

ATI-1777 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol ACRS. Aclaris is the sponsor of the clinical program evaluating the drug in atopic dermatitis.

What phase is ATI-1777 in?

ATI-1777 is in Phase 2 development. A Phase 2 trial in adult patients with moderate or severe atopic dermatitis has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ATI-1777 in?

ATI-1777 has been studied in one clinical trial, NCT04598269, titled Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis. This completed Phase 2 trial enrolled 50 participants in the United States. It was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.