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ATI-045

Phase 2

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

Target and mechanism

Molecular targetTSLP
Target classCytokine
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

ATI-045 · 1 trial · 5 indications

Phase 2 1
NCT07011706ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic DermatitisAtopic Dermatitis
ACTIVE NOT_RECRUITING110 Analytics
PHASE2ACTIVE NOT_RECRUITING
ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

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 to 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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Frequently asked questions about ATI-045

What is ATI-045 used for?

ATI-045 is an investigational small molecule being developed for the treatment of moderate-to-severe atopic dermatitis, also known as eczema. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does ATI-045 target?

ATI-045 targets TSLP, a cytokine involved in inflammatory responses. By targeting TSLP, the drug aims to modulate the immune pathways implicated in atopic dermatitis. This mechanism is being evaluated in clinical trials for patients with moderate-to-severe disease.

Who is developing ATI-045?

Aclaris Therapeutics, Inc. (NASDAQ: ACRS) is developing ATI-045. The company is conducting a Phase 2 clinical trial of the drug in patients with moderate-to-severe atopic dermatitis.

What phase is ATI-045 in?

ATI-045 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. A Phase 2 trial is currently active but not recruiting participants.

What clinical trials is ATI-045 in?

ATI-045 is being studied in a Phase 2 trial with the identifier NCT07011706. This randomized, double-blind, placebo-controlled study enrolls approximately 110 adults with moderate-to-severe atopic dermatitis at sites in the United States and Canada.

Is ATI-045 the same as any other drug?

No alternative names for ATI-045 have been disclosed. It is a distinct investigational small molecule being developed by Aclaris Therapeutics for atopic dermatitis.