Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-1777 topical solution 2.0% w/w (BID) | Experimental | ATI-1777 topical solution 2.0% w/w, twice daily |
|
| ATI-1777 topical solution 1.0% w/w (BID) | Experimental | ATI-1777 topical solution 1.0% w/w, twice daily |
|
| ATI-1777 topical solution 0.5% w/w (BID) | Experimental | ATI-1777 topical solution 0.5% w/w, twice daily |
|
| Vehicle (BID) | Placebo Comparator | Vehicle topical solution, twice daily |
|
| ATI-1777 topical solution 2.0% w/w (QD) | Experimental | ATI-1777 topical solution 2.0% w/w, once daily |
|
| Vehicle (QD) | Placebo Comparator | Vehicle topical solution, once daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-1777 2.0% w/w | Drug | ATI-1777 topical solution 2.0% w/w |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in EASI score at each post-baseline study visit | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Birmingham | Alabama | 35244 | United States | ||
| Aclaris Investigational Site |
Not provided
Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
Not provided
Not provided
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|
| ATI-1777 1.0% w/w | Drug | ATI-1777 topical solution 1.0% w/w |
|
| ATI-1777 0.5% w/w | Drug | ATI-1777 topical solution 0.5% w/w |
|
| Vehicle | Drug | Vehicle topical solution |
|
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. |
| 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 | Baseline to Day 42 |
| Change from baseline in vIGA score at each post-baseline study visit | 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 | 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. | 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 | Baseline to Day 28 |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Aclaris Investigational Site | Bryant | Arkansas | 72022 | United States |
| Aclaris Investigational Site | North Little Rock | Arkansas | 72117 | United States |
| Aclaris Investigational Site | Encinitas | California | 92024 | United States |
| Aclaris Investigational Site | Encino | California | 91436 | United States |
| Aclaris Investigational Site | Castle Rock | Colorado | 80109 | United States |
| Aclaris Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| Aclaris Investigational Site | Delray Beach | Florida | 33484 | United States |
| Aclaris Investigational Site | Miami | Florida | 33173 | United States |
| Aclaris Investigational Site | Miami Lakes | Florida | 33014 | United States |
| Aclaris Investigational Site | Tampa | Florida | 33613 | United States |
| Aclaris Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Aclaris Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Aclaris Investigational Site | Normal | Illinois | 61761 | United States |
| Aclaris Investigational Site | Skokie | Illinois | 60077 | United States |
| Aclaris Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Aclaris Investigational Site | New Albany | Indiana | 47150 | United States |
| Aclaris Investigational Site | West Lafayette | Indiana | 47906 | United States |
| Aclaris Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Aclaris Investigational Site | Houma | Louisiana | 70364 | United States |
| Aclaris Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| Aclaris Investigational Site | Wilmington | North Carolina | 28405 | United States |
| Aclaris Investigational Site | Oklahoma City | Oklahoma | 73118 | United States |
| Aclaris Investigational Site | Medford | Oregon | 97504 | United States |
| Aclaris Investigational Site | Greenville | South Carolina | 29615 | United States |
| Aclaris Investigational Site | Murfreesboro | Tennessee | 37130 | United States |
| Aclaris Investigational Site | Arlington | Texas | 76011 | United States |
| Aclaris Investigational Site | Dallas | Texas | 75230 | United States |
| Aclaris Investigational Site | Houston | Texas | 77004 | United States |
| Aclaris Investigational Site | San Antonio | Texas | 78213 | United States |
| Aclaris Investigational Site | Richmond | Virginia | 23233 | United States |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided