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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
ATI-1777 topical solution 2.0% w/w
ATI-1777 topical solution 1.0% w/w
ATI-1777 topical solution 0.5% w/w
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time frame: Baseline to Day 28
Percentage change from baseline in EASI score at each post-baseline study visit
Time frame: Baseline to Day 42
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.
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Time frame: Baseline to Day 42
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
Time frame: Baseline to Day 42
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vehicle topical solution
Aclaris Investigational Site
Birmingham, Alabama, United States
Aclaris Investigational Site
Scottsdale, Arizona, United States
Aclaris Investigational Site
Bryant, Arkansas, United States
Aclaris Investigational Site
North Little Rock, Arkansas, United States
Aclaris Investigational Site
Encinitas, California, United States
Aclaris Investigational Site
Encino, California, United States
Aclaris Investigational Site
Castle Rock, Colorado, United States
Aclaris Investigational Site
Colorado Springs, Colorado, United States
Aclaris Investigational Site
Delray Beach, Florida, United States
Aclaris Investigational Site
Miami, Florida, United States
...and 22 more locations
Change from baseline in vIGA score at each post-baseline study visit
Time frame: Baseline to Day 42
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
BSA is defined as a percentage of the total body (0-100) that is affected by disease
Time frame: Baseline to Day 42
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Time frame: Baseline to Day 42
Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.study visit
Time frame: Baseline to Day 28