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

NCT06585202 | Completed Phase 2 FDA Drug

• 1 other identifier: ATI-2138-AD-201
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Eczema; Dermatitis; Dermatitis, Atopic; Skin Diseases, Eczematous; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent adverse events (TEAEs)

  From baseline up to two weeks after treatment (Day 98)

Secondary Outcomes (8)

• Change from baseline Eczema Area and Severity Index (EASI) Over Time

  Up to Week 12

• Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time

  Up to Week 12

• Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time

  Up to Week 12

• Change in IGA score over time

  Up to Week 12

• Change from baseline in AD Body Surface Area (BSA) over time

  Up to week 12

Study Arms (1)

ATI-2138

EXPERIMENTAL

ATI-2138 oral tablets BID

Drug: ATI-2138

Interventions

ATI-2138 DRUG

ATI-2138 Oral Tablets BID

ATI-2138

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (6)

Aclaris Investigational Site

Birmingham, Alabama, 35244, United States

Location

Aclaris Investigational Site

Encino, California, 91436, United States

Location

Aclaris Investigational Site

San Diego, California, 92123, United States

Location

Aclaris Investigational Site

Plainfield, Indiana, 46168, United States

Location

Aclaris Investigational Site

Austin, Texas, 78759, United States

Location

Aclaris Investigational Site

San Antonio, Texas, 78213, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Skin Diseases, Eczematous; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ajay Aggarwal, MD

  Aclaris Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: August 19, 2024
• Primary Completion: March 13, 2025
• Study Completion: March 31, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-02

Locations

US (6)