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

Aclaris Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: ATI-2138

Study type

Interventional

Funder types

Industry

Identifiers

NCT06585202

ATI-2138-AD-201

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.