Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis

Last updated: March 10, 2026
Sponsor: Aclaris Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Rash

Dermatitis, Atopic

Atopic Dermatitis

Treatment

ATI-2138

Clinical Study ID

NCT06585202
ATI-2138-AD-201
  • Ages 18-60
  • All Genders

Study Summary

This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to comprehend and willing to sign the IRB approved ICF/assent prior toadministration 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 history of moderate or severe AD prior to the ScreeningVisit, and no significant AD flares for the 4 weeks prior to the Screening Visit asdetermined by the Investigator upon review of participant medical history.

Exclusion

Exclusion Criteria:

  • Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any timeprior to Screening.

  • Unstable course of AD (spontaneously improving or rapidly deteriorating) based onthe patient history or as determined by the investigator during the ScreeningPeriod.

  • Refractory AD (ie, AD that required frequent hospitalizations and/or frequentintravenous treatment for skin infections within the year before the ScreeningVisit).

  • Concomitant skin disease or clinically infected AD or presence of other skin diseasein the area to be dosed that may interfere with study assessments.

  • Female patients who are pregnant, nursing, or planning to become pregnant during thestudy.

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: ATI-2138
Phase: 2
Study Start date:
August 19, 2024
Estimated Completion Date:
March 31, 2025

Study Description

This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.

Connect with a study center

  • Aclaris Investigational Site

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Aclaris Investigational Site

    Encino, California 91436
    United States

    Site Not Available

  • Aclaris Investigational Site

    San Diego, California 92123
    United States

    Site Not Available

  • Aclaris Investigational Site

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Aclaris Investigational Site

    Austin, Texas 78759
    United States

    Site Not Available

  • Aclaris Investigational Site

    San Antonio, Texas 78213
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.