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

NCT ID: NCT06585202

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-03-27

Brief Summary

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

Detailed 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATI-2138

ATI-2138 oral tablets BID

Group Type: EXPERIMENTAL

ATI-2138

Intervention Type: DRUG

ATI-2138 Oral Tablets BID

Interventions

ATI-2138

ATI-2138 Oral Tablets BID

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aclaris Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajay Aggarwal, MD

Role: STUDY_DIRECTOR

Aclaris Therapeutics, Inc.

Locations

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

Countries

United States

Other Identifiers

ATI-2138-AD-201

Identifier Type: -

Identifier Source: org_study_id