This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD).
This is a placebo controlled study where subjects with moderate to severe atopic dermatitis will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month open-label extension study (OLE). There will be a 4-week follow up period for subjects not participating in the OLE study. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
244
Daily dose of ASN002 for 12 weeks
Placebo of ASN002 for 12 weeks
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.
Time frame: Week 12
Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)
Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12
Time frame: Week 12
Change From Baseline in 5-D Pruritus (Itching) Scale
The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst).
Time frame: Week 12
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease.
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Total Skin and Dermatology Center, PC.
Birmingham, Alabama, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
L.A. Universal Research Center, Inc.
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Revival Research
Doral, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States
Dermatology Consulting Services
Tampa, Florida, United States
Forward Clinical Trials
Tampa, Florida, United States
...and 37 more locations
Time frame: Week 12
Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1
The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The 0 is the least severe and 4 is the most severe.
Time frame: Week 12
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is.
Time frame: Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is.
Time frame: Week 12
Change From Baseline in Body Surface Area (BSA)
The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%).
Time frame: Week 12