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ATI-2138

Phase 2

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

ATI-2138 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2024

ATI-2138 target and mechanism

Molecular targetITK
Target classKinase
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

ATI-2138 clinical trials

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 moderate to severe atopic dermatitis in adults. It is not yet approved for any indication and remains in clinical development, with a Phase 2 study completed in adult participants with atopic dermatitis.

What does ATI-2138 target?

ATI-2138 targets ITK, which stands for interleukin-2 inducible T cell kinase. ITK is a kinase enzyme involved in T cell signaling. By targeting ITK, ATI-2138 is designed to modulate T cell driven inflammatory pathways relevant to atopic dermatitis.

Who is developing ATI-2138?

ATI-2138 is being developed by Aclaris Therapeutics, Inc., which trades on the Nasdaq under the ticker ACRS. Aclaris is a biopharmaceutical company focused on developing therapies in immunology and dermatology, and ATI-2138 is one of its clinical-stage assets.

What phase is ATI-2138 in?

ATI-2138 is in Phase 2 development. A Phase 2 study in adult participants with moderate to 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-2138 in?

ATI-2138 has been studied in one clinical trial, NCT06585202, titled Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis. This Phase 2 trial enrolled 14 participants in the United States and is now completed. It was an uncontrolled study without randomization or blinding.