This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.
This study is being conducted to evaluate the efficacy, safety, and molecular effects of abrocitinib in subjects with an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab. Approximately 60 subjects with atopic dermatitis will receive abrocitinib once daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
100 mg Abrocitinib once daily (QD) for 12 weeks
Inno-6050 Site 22
Birmingham, Alabama, United States
Inno-6050 Site 13
Fountain Valley, California, United States
Inno-6050 Site 21
Miami Lakes, Florida, United States
Change from baseline of Eczema Area and Severity Index (EASI)
The EASI is a composite score ranging from 0 to 72 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 body surface area (BSA) involved for each body region and for the proportion of the body region to the whole body. The primary endpoint is the change from baseline in EASI at Week 12.
Time frame: at Week 12
Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
The vIGA-AD is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity.
Time frame: at Week 12
Change from baseline of Body Surface Area (BSA)
The overall BSA affected by disease will be evaluated (from 0% to 100%). The palmar surface of one hand (using the patient's hand and including the fingers) represents 1% of the total BSA.
Time frame: at Week 12
Change from baseline of Peak pruritus Numerical Rating Scale (NRS)
The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score representing of the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst imaginable symptoms.
Time frame: over 12 weeks
Change from baseline of Facial Eczema Area and Severity Index (EASI)
The facial EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of six facial regions, with adjustment for the percentage of facial surface area involved for each facial region, using the "rule of fours".
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Inno-6050 Site 19
St. Petersburg, Florida, United States
Inno-6050 Site 16
Quincy, Massachusetts, United States
Inno-6050 Site 17
Auburn Hills, Michigan, United States
Inno-6050 Site 15
Winnipeg, Manitoba, Canada
Inno-6050 Site 18
Newmarket, Ontario, Canada
Inno-6050 Site 11
Toronto, Ontario, Canada
Inno-6050 Site 10
Montreal, Quebec, Canada
...and 2 more locations
Time frame: at Week 12
Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
The modified vIGA-AD will be used to assess the severity of lesions on the face for subjects with facial erythema at baseline and on the trunk and/or limbs for subjects with atopic dermatitis (AD) on those body parts at baseline.
Time frame: at Week 12
Change from baseline of the CCL18 Skin Biomarker Level
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in CCL18 skin biomarker levels in lesional and nonlesional skin samples.
Time frame: at Week 12
Change from baseline of the MMP12 Skin Biomarker Level
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in MMP12 skin biomarker levels lesional and nonlesional skin samples.
Time frame: at Week 12
Change from baseline of the Keratin 16 Skin Biomarker Level
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in Keratine 16 skin biomarker levels lesional and nonlesional skin samples.
Time frame: at Week 12
Change from baseline of the S100A7 Skin Biomarker Level
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A7 skin biomarker levels lesional and nonlesional skin samples.
Time frame: at Week 12
Change from baseline of the S100A8 Skin Biomarker Level
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A8 skin biomarker levels lesional and nonlesional skin samples.
Time frame: at Week 12
Change from baseline of the S100A9 Skin Biomarker Level
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A9 skin biomarker levels lesional and nonlesional skin samples.
Time frame: at Week 12