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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT06585202

Run by

Aclaris Therapeutics, Inc.

People needed

14

Starts

2024-08-19

Expected to finish

2025-03-31

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aclaris Investigational Site — Birmingham, Alabama, United States
• Aclaris Investigational Site — Encino, California, United States
• Aclaris Investigational Site — San Diego, California, United States
• Aclaris Investigational Site — Plainfield, Indiana, United States
• Aclaris Investigational Site — Austin, Texas, United States
• Aclaris Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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