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

Last updated: April 25, 2025
Sponsor: Aclaris Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Dermatitis, Atopic

Skin Infections/disorders

Hives (Urticaria)

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 27, 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

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