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

Recruiting
18 years - 60 years
All
Fase 2
15 participants needed
6 Locations

Brief description of study

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

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis
  • Age: 18 years - 60 years
  • Gender: All

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.

Updated on 22 Nov 2024. Study ID: NCT06585202

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