Recent Updates
Recently added Catalysts

ATI-1777 2.0% w/w

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Aclaris Therapeutics, Inc.|Last Updated: Oct 26, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

ATI-1777 2.0% w/w · 1 trial · 1 indication

Phase 2 1
NCT05432596Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic DermatitisAtopic Dermatitis
COMPLETED250 Analytics
PHASE2COMPLETED
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
Baseline to Day 28

EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

Secondary Endpoints

Percentage change from baseline in EASI score at each post-baseline study visit
Baseline to Day 42
Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.
Baseline to Day 42
Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit
Baseline to Day 42
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATI-1777 topical solution 2.0% w/w (BID)EXPERIMENTALATI-1777 topical solution 2.0% w/w, twice daily
ATI-1777 topical solution 1.0% w/w (BID)EXPERIMENTALATI-1777 topical solution 1.0% w/w, twice daily
ATI-1777 topical solution 0.5% w/w (BID)EXPERIMENTALATI-1777 topical solution 0.5% w/w, twice daily
Vehicle (BID)PLACEBO_COMPARATORVehicle topical solution, twice daily
ATI-1777 topical solution 2.0% w/w (QD)EXPERIMENTALATI-1777 topical solution 2.0% w/w, once daily
Vehicle (QD)PLACEBO_COMPARATORVehicle topical solution, once daily

Interventions

NameTypeDescription
ATI-1777 2.0% w/wDRUGATI-1777 topical solution 2.0% w/w
ATI-1777 1.0% w/wDRUGATI-1777 topical solution 1.0% w/w
ATI-1777 0.5% w/wDRUGATI-1777 topical solution 0.5% w/w
VehicleDRUGVehicle topical solution
Unlock Study Design Details

Eligibility Criteria

Age Range12 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: 1. Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures. 2. Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent. 3. Have at least a 6-mo...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about ATI-1777 2.0% w/w

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 formulated as a 2.0% w/w topical product. The drug 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 traded on NASDAQ under the ticker symbol ACRS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational topical treatment for atopic dermatitis.

What phase is ATI-1777 in?

ATI-1777 is in Phase 2 clinical development. A Phase 2 study has been completed, evaluating the drug in patients aged 12 to 65 years with mild to severe atopic dermatitis. The drug is investigational and has not received FDA approval.

What clinical trials is ATI-1777 in?

ATI-1777 has one completed Phase 2 clinical trial, identified as NCT05432596. This randomized, double-blind, placebo-controlled study enrolled 250 participants with mild to severe atopic dermatitis in the United States. The trial included patients aged 12 years and older.

How does ATI-1777 work?

ATI-1777 is a small molecule designed to treat atopic dermatitis, but its specific molecular target has not been disclosed. The drug is applied topically as a 2.0% w/w formulation, intended to address the inflammatory processes underlying the skin condition.