Effects of Abrocitinib Treatment on Skin Barrier Function (AbroSkib)

Prof. Dr. Stephan Weidinger

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05140239

ABRO_WEI_2021

Details and patient eligibility

About

Effects of abrocitinib treatment of atopic dermatitis on skin barrier function.

Full description

Open-label, non-randomized, single-arm, 12-weeks observational clinical and translational study

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent obtained from the subject prior to performing any protocol-related pro-cedures, including screening evaluations
2. Age ≥ 18 years at time of study entry.
3. Diagnosis of chronic atopic dermatitis for at least 1 year prior to enrollment based on American Academy Criteria
4. Eczema Area and Severity Index (EASI) score ≥12 at baseline visit (Week 0)
5. Investigator Global Assessment (IGA) ≥3 at baseline visit (Week 0)
6. Subject is willing and able to comply with the protocol for the duration of the study
7. Subject receives abrocitinib by the treating dermatologist within routine care

Exclusion criteria

1. 1. Subject is unable to provide written informed consent or comply with the protocol
2. Concurrent enrolment in another clinical trial where the subject is receiving an IMP or participation in another clinical trial with investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer.
3. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with as-sessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
4. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
5. Having used systemic immunosuppressive/immunomodulating therapy (e.g. systemic corticoster-oids methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors) or tanning beds or phototherapy during any week within the 4 weeks or receipt of any marketed biologic ther-apy (e.g., dupilumab, tralokinumab) within 3 months or 5 half-lives, whichever is longer, prior to baseline
6. Treatment of selected marker skin areas (non-lesional skin at volar forearm and extensor forearm, lesional skin) with topical corticosteroid or topical calcineurin inhibitor 1 week prior to baseline visit and throughout the study.
7. Treatment of skin areas of examination with emollients 24 hours prior to baseline visit and throughout the study.
8. Involvement in the planning and/or conduct of the study.

Trial design

20 participants in 1 patient group

AbroSkib Cohort

Description:

Adult patients with moderate to severe atopic dermatitis who are eligible for and will receive systemic therapy with abrocitinib by their treating dermatologist as part of standard healthcare (n=20). The choice of therapy is strictly done by the treating dermatologist only, and the reasons for the choice will be captured by a structured documentation.

Treatment:

Other: No Intervention