Clinical trial NCT05432596: Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
Primary purpose: TREATMENT

Brief summary: This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.


Eligibility criteria: Inclusion Criteria:

1. Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
2. Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
3. Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit.

Exclusion Criteria:

1. Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
2. 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.
3. Female patients who are pregnant, nursing, or planning to become pregnant during the study.

Primary outcomes:
measure: Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Percentage change from baseline in EASI score at each post-baseline study visit
timeFrame: Baseline to Day 42
measure: Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.
timeFrame: Baseline to Day 42
measure: Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit
timeFrame: Baseline to Day 42
measure: Change from baseline in vIGA score at each post-baseline study visit
timeFrame: Baseline to Day 42
measure: Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
timeFrame: Baseline to Day 42
measure: Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
timeFrame: Baseline to Day 42
measure: Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Aclaris Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: Aclaris Investigational Site
state: Arizona
city: Bryant
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: North Little Rock
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: Encinitas
country: United States
facility: Aclaris Investigational Site
state: California
city: Encino
country: United States
facility: Aclaris Investigational Site
state: California
city: Castle Rock
country: United States
facility: Aclaris Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Aclaris Investigational Site
state: Colorado
city: Delray Beach
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Miami
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Tampa
country: United States
facility: Aclaris Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Sandy Springs
country: United States
facility: Aclaris Investigational Site
state: Georgia
city: Normal
country: United States
facility: Aclaris Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Aclaris Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: West Lafayette
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: Baton Rouge
country: United States
facility: Aclaris Investigational Site
state: Louisiana
city: Houma
country: United States
facility: Aclaris Investigational Site
state: Louisiana
city: Saint Joseph
country: United States
facility: Aclaris Investigational Site
state: Missouri
city: Wilmington
country: United States
facility: Aclaris Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Aclaris Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Aclaris Investigational Site
state: Oregon
city: Greenville
country: United States
facility: Aclaris Investigational Site
state: South Carolina
city: Murfreesboro
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Dallas
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Houston
country: United States
facility: Aclaris Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Richmond
country: United States
facility: Aclaris Investigational Site
state: Virginia
Study officials:
References: