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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    15
  • sponsor
    Aclaris Therapeutics, Inc.
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Updated on 23 January 2025
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Summary

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

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.

Details
Condition Atopic Dermatitis
Age 18years - 60years
Clinical Study IdentifierNCT06585202
SponsorAclaris Therapeutics, Inc.
Last Modified on23 January 2025

Eligibility

 Yes No Not Sure

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 history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history

Exclusion Criteria

Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening
Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period
Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit)
Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments
Female patients who are pregnant, nursing, or planning to become pregnant during the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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