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

Aclaris Therapeutics

Status and phase: Active, not recruiting; 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: 14 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

ATI-2138

Experimental group

Description:

ATI-2138 oral tablets BID

Treatment:

Drug: ATI-2138

Sponsor of this trial

Lead Sponsor

Aclaris Therapeutics