A Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants With Moderate to Severe Atopic Dermatitis

Aclaris Therapeutics, Inc.6 sites in 1 country14 target enrollmentAugust 19, 2024

ConditionsAtopic Dermatitis

InterventionsATI-2138

DrugsATI-2138

Overview

Phase: Phase 2
Intervention: ATI-2138
Conditions: Atopic Dermatitis
Sponsor: Aclaris Therapeutics, Inc.
Enrollment: 14
Locations: 6
Primary Endpoint: Incidence and severity of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 19, 2024

End Date

March 31, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Aclaris Therapeutics, Inc.

Responsible Party

Sponsor

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.

Arms & Interventions

ATI-2138

ATI-2138 oral tablets BID

Intervention: ATI-2138

Outcomes

Primary Outcomes

Incidence and severity of treatment emergent adverse events (TEAEs)

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

Secondary Outcomes

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)