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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: ATI-2138

• Registration Number: NCT06585202
• Lead Sponsor: Aclaris Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2024-08-19
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-05
• Status Verified: 2024-11
• Primary Completion: 2025-03-13
• Study Completion: 2025-03-27
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATI-2138	ATI-2138	ATI-2138 oral tablets BID

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent adverse events (TEAEs)	From baseline up to two weeks after treatment (Day 98)

Secondary Outcome Measures

Name	Time	Method
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 from baseline in AD Body Surface Area (BSA) over time	Up to week 12
Change in IGA score over time	Up to Week 12
Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time	Up to Week 12
ATI-2138 trough concentration ng/mL	Day 1 to Week 12
ATI-2138 peak concentration (Cmax) ng/mL	Day 1 to Week 12

Trial Locations

Locations (1)

Aclaris Investigational Site; 🇺🇸 San Antonio, Texas, United States