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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abrocitinib 100 mg tablet (marketed drug) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abrocitinib | Drug | 100 mg Abrocitinib once daily (QD) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at Week 12 |
| Change from baseline of Body Surface Area (BSA) |
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Inclusion Criteria:
Male or female subject 18 years of age or older, at the time of consent.
Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
Subjects who had moderate to severe AD before initiating dupilumab treatment.
Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD | Innovaderm Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inno-6050 Site 22 | Birmingham | Alabama | 35244 | United States | ||
| Inno-6050 Site 13 |
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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. |
| 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. | 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". | 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. | 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. | 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. | 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. | 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. | 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. | 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. | at Week 12 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Inno-6050 Site 21 | Miami Lakes | Florida | 33014 | United States |
| Inno-6050 Site 19 | St. Petersburg | Florida | 33709 | United States |
| Inno-6050 Site 16 | Quincy | Massachusetts | 02169 | United States |
| Inno-6050 Site 17 | Auburn Hills | Michigan | 48326 | United States |
| Inno-6050 Site 15 | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Inno-6050 Site 18 | Newmarket | Ontario | L3Y 5G8 | Canada |
| Inno-6050 Site 11 | Toronto | Ontario | M4W 2N4 | Canada |
| Inno-6050 Site 10 | Montreal | Quebec | H2X 2V1 | Canada |
| Inno-6050 Site 14 | Québec | Quebec | G1V 4X7 | Canada |
| Inno-6050 Site 20 | Québec | Quebec | G1W 4R4 | Canada |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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 |
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| ID | Term |
|---|---|
| C000634427 | abrocitinib |
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