Effects of Abrocitinib Treatment on Skin Barrier Function (AbroSkib)

July 18, 2023 updated by: Prof. Dr. Stephan Weidinger

Effects of Abrocitinib Treatment of Moderate to Severe Atopic Dermatitis on Skin Barrier Function

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (n=20) 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. 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AbroSkib Cohort
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.
Other: No Intervention
Non Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in transepidermal water loss (TEWL) at one non-lesional and one lesional marker skin area at week 2 and week 12 compared to baseline/week 0 (day 0).
Time Frame: 12 Weeks
To determine the mean change of TEWL in g/m2/h at one non-lesional and one lesional marker skin site at week 2 and week 12 compared to baseline
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of epidermal barrier-related genes/pathways differentially expressed in a marker lesional skin site at week 2 and week 12 compared to baseline
Time Frame: 12 Weeks
To compare the expression of epidermal barrier-related genes at the transcriptome level at a marker lesional skin site at week 2 and week 12 to baseline and to non-lesional skin
12 Weeks
Epidermal thickness and epidermal differentiation markers in a marker lesional skin site at week 2 and week 12 compared to baseline
Time Frame: 12 Weeks
To compare epidermal thickness (in µm) and the percentage of marker-positive cells (KRT 16, Ki67, FLG) in a marker skin site with reference to the number of cells in the basal layer at week 2 and 12 to baseline and to non-lesional skin
12 Weeks
Stratum corneum biomarker (cytokine) levels (pg/μg protein) in marker skin sites at week 2 and week 12 compared to baseline
Time Frame: 12 Weeks
To compare stratum corneum biomarker (cytokine) levels (pg/μg protein) in a marker lesional skin site at week 2 and week 12 compared to baseline and to non-lesional skin
12 Weeks
Composition of Bacterial Taxa of one lesional and non-lesional marker skin area at week 2 and week 12 compared to baseline
Time Frame: 12 Weeks
To identify changes in community composition and diversity at one lesional and one non-lesional marker skin site at week 2 and week 12 as compared to baseline using Next Generation Sequencing techniques
12 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptional profile of the keratinocytes in one lesional marker skin area at week 2 and 12 compared to baseline
Time Frame: 12 Weeks
To compare the transcriptional profile of keratinocytes at one lesional marker skin area at week 2 and 12 compared to baseline and to non-lesional skin using single cell sequencing techniques
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Stephan Weidinger

Investigators

  • Principal Investigator: Stephan Weidinger, MD, UKSH Kiel, University of Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABRO_WEI_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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