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ATI-2138

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Aclaris Therapeutics, Inc.|Last Updated: Mar 12, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

ATI-2138 · 1 trial · 1 indication

Phase 2 1
NCT06585202Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic DermatitisAtopic Dermatitis
COMPLETED14 Analytics
PHASE2COMPLETED
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of treatment emergent adverse events (TEAEs)
From baseline up to two weeks after treatment (Day 98)

Secondary Endpoints

Change from baseline Eczema Area and Severity Index (EASI) Over Time
Up to Week 12
Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time
Up to Week 12
Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time
Up to Week 12
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATI-2138EXPERIMENTALATI-2138 oral tablets BID

Interventions

NameTypeDescription
ATI-2138DRUGATI-2138 Oral Tablets BID
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures. * Male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent. * Have at least a 1-year ...

Countries:United States
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Frequently asked questions about ATI-2138

What is ATI-2138 used for?

ATI-2138 is an investigational small molecule being developed for the treatment of atopic dermatitis, a form of eczema. It is currently in Phase 2 clinical development and has been studied in adult participants with moderate to severe atopic dermatitis.

Who makes ATI-2138?

ATI-2138 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACRS. The company is conducting clinical research on this investigational drug for atopic dermatitis.

What phase is ATI-2138 in?

ATI-2138 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating atopic dermatitis.

What clinical trials is ATI-2138 in?

ATI-2138 has been studied in a Phase 2 clinical trial identified as NCT06585202, titled 'Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis.' This trial was conducted in the United States and enrolled 14 adult participants.

Is ATI-2138 a small molecule?

Yes, ATI-2138 is a small molecule drug. It is being developed as a therapeutic for atopic dermatitis, a dermatological condition. The drug is administered to adult participants with moderate to severe forms of the disease.