Clinical trial NCT05602207: Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab
Official title: Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: eczema
dupilumab
abrocitinib
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subject 18 years of age or older, at the time of consent.
2. Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
3. Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
4. Subjects who had moderate to severe AD before initiating dupilumab treatment.
5. Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:

   1. A global vIGA-AD ≥ 2, at least 1% BSA with facial erythema, and a modified vIGA-AD for the face ≥2 at screening and Day 1 OR
   2. A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1.

Exclusion Criteria:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has clinically infected AD.
3. Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
4. Subject has a history of cancer within 5 years prior to Day 1.
5. Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
6. Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
7. Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
8. Subject has a current or recent clinically serious infection.
9. Subject has used abrocitinib prior to Day 1.
10. Subject has a known hypersensitivity to abrocitinib or its excipients.
11. Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.

Primary outcomes:
measure: Change from baseline of Eczema Area and Severity Index (EASI)
timeFrame: at Week 12
Secondary outcomes:
measure: Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
timeFrame: at Week 12
measure: Change from baseline of Body Surface Area (BSA)
timeFrame: at Week 12
measure: Change from baseline of Peak pruritus Numerical Rating Scale (NRS)
timeFrame: over 12 weeks
measure: Change from baseline of Facial Eczema Area and Severity Index (EASI)
timeFrame: at Week 12
measure: Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
timeFrame: at Week 12
measure: Change from baseline of the CCL18 Skin Biomarker Level
timeFrame: at Week 12
measure: Change from baseline of the MMP12 Skin Biomarker Level
timeFrame: at Week 12
measure: Change from baseline of the Keratin 16 Skin Biomarker Level
timeFrame: at Week 12
measure: Change from baseline of the S100A7 Skin Biomarker Level
timeFrame: at Week 12
measure: Change from baseline of the S100A8 Skin Biomarker Level
timeFrame: at Week 12
measure: Change from baseline of the S100A9 Skin Biomarker Level
timeFrame: at Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Inno-6050 Site 22
state: Alabama
city: Fountain Valley
country: United States
facility: Inno-6050 Site 13
state: California
city: Miami Lakes
country: United States
facility: Inno-6050 Site 21
state: Florida
city: Saint Petersburg
country: United States
facility: Inno-6050 Site 19
state: Florida
city: Quincy
country: United States
facility: Inno-6050 Site 16
state: Massachusetts
city: Auburn Hills
country: United States
facility: Inno-6050 Site 17
state: Michigan
city: Winnipeg
country: Canada
facility: Inno-6050 Site 15
state: Manitoba
city: Newmarket
country: Canada
facility: Inno-6050 Site 18
state: Ontario
city: Toronto
country: Canada
facility: Inno-6050 Site 11
state: Ontario
city: Montreal
country: Canada
facility: Inno-6050 Site 10
state: Quebec
city: Québec
country: Canada
facility: Inno-6050 Site 14
state: Quebec
city: Québec
country: Canada
facility: Inno-6050 Site 20
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: