Clinical trial NCT06585202: Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases, Eczematous
Skin Diseases
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence and severity of treatment emergent adverse events (TEAEs)
timeFrame: From baseline up to two weeks after treatment (Day 98)
Secondary outcomes:
measure: Change from baseline Eczema Area and Severity Index (EASI) Over Time
timeFrame: Up to Week 12
measure: Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time
timeFrame: Up to Week 12
measure: Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time
timeFrame: Up to Week 12
measure: Change in IGA score over time
timeFrame: Up to Week 12
measure: Change from baseline in AD Body Surface Area (BSA) over time
timeFrame: Up to week 12
measure: Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time
timeFrame: Up to Week 12
measure: ATI-2138 trough concentration ng/mL
timeFrame: Day 1 to Week 12
measure: ATI-2138 peak concentration (Cmax) ng/mL
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Aclaris Investigational Site
state: Alabama
city: Encino
country: United States
facility: Aclaris Investigational Site
state: California
city: San Diego
country: United States
facility: Aclaris Investigational Site
state: California
city: Plainfield
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: Austin
country: United States
facility: Aclaris Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Aclaris Investigational Site
state: Texas
Study officials:
affiliation: Aclaris Therapeutics, Inc.
name: Ajay Aggarwal, MD
role: STUDY_DIRECTOR
References: