Effects of Abrocitinib Treatment on Skin Barrier Function

NCT05140239 | Active Not Recruiting DMC

• 1 other identifier: ABRO_WEI_2021
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Skin Barrier; Atopic Dermatitis; Dermatology; Skin Physiology

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (4)

• Number of epidermal barrier-related genes/pathways differentially expressed in a marker lesional skin site at week 2 and week 12 compared to baseline

  12 Weeks

• Epidermal thickness and epidermal differentiation markers in a marker lesional skin site at week 2 and week 12 compared to baseline

  12 Weeks

• Stratum corneum biomarker (cytokine) levels (pg/μg protein) in marker skin sites at week 2 and week 12 compared to baseline

  12 Weeks

• Composition of Bacterial Taxa of one lesional and non-lesional marker skin area at week 2 and week 12 compared to baseline

  12 Weeks

Other Outcomes (1)

• Transcriptional profile of the keratinocytes in one lesional marker skin area at week 2 and 12 compared to baseline

  12 Weeks

Study Arms (1)

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

Interventions

No Intervention OTHER

Non Interventional

AbroSkib Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \. Subject is unable to provide written informed consent or comply with the protocol
• 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.
• Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
• 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
• 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.
• Treatment of skin areas of examination with emollients 24 hours prior to baseline visit and throughout the study.
• Involvement in the planning and/or conduct of the study.

Sponsors & Collaborators

• Prof. Dr. Stephan Weidinger: lead

Study Sites (1)

UKSH, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (24)

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• Tsoi LC, Rodriguez E, Stolzl D, Wehkamp U, Sun J, Gerdes S, Sarkar MK, Hubenthal M, Zeng C, Uppala R, Xing X, Thielking F, Billi AC, Swindell WR, Shefler A, Chen J, Patrick MT, Harms PW, Kahlenberg JM, Perez White BE, Maverakis E, Gudjonsson JE, Weidinger S. Progression of acute-to-chronic atopic dermatitis is associated with quantitative rather than qualitative changes in cytokine responses. J Allergy Clin Immunol. 2020 May;145(5):1406-1415. doi: 10.1016/j.jaci.2019.11.047. Epub 2019 Dec 28.

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• Tsoi LC, Rodriguez E, Degenhardt F, Baurecht H, Wehkamp U, Volks N, Szymczak S, Swindell WR, Sarkar MK, Raja K, Shao S, Patrick M, Gao Y, Uppala R, Perez White BE, Getsios S, Harms PW, Maverakis E, Elder JT, Franke A, Gudjonsson JE, Weidinger S. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019 Jul;139(7):1480-1489. doi: 10.1016/j.jid.2018.12.018. Epub 2019 Jan 11.

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• Mobus L, Rodriguez E, Harder I, Stolzl D, Boraczynski N, Gerdes S, Kleinheinz A, Abraham S, Heratizadeh A, Handrick C, Haufe E, Werfel T, Schmitt J, Weidinger S; TREATgermany study group. Atopic dermatitis displays stable and dynamic skin transcriptome signatures. J Allergy Clin Immunol. 2021 Jan;147(1):213-223. doi: 10.1016/j.jaci.2020.06.012. Epub 2020 Jun 29.

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• Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis Primers. 2018 Jun 21;4(1):1. doi: 10.1038/s41572-018-0001-z.

  PMID: 29930242 BACKGROUND

• Thaci D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, Soong W, Worm M, Szepietowski JC, Sofen H, Kawashima M, Wu R, Weinstein SP, Graham NM, Pirozzi G, Teper A, Sutherland ER, Mastey V, Stahl N, Yancopoulos GD, Ardeleanu M. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 2;387(10013):40-52. doi: 10.1016/S0140-6736(15)00388-8. Epub 2015 Oct 8.

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• Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

  PMID: 28478972 BACKGROUND

• Abraham S, Haufe E, Harder I, Heratizadeh A, Kleinheinz A, Wollenberg A, Weisshaar E, Augustin M, Wiemers F, Zink A, Biedermann T, von Kiedrowski R, Hilgers M, Worm M, Pawlak M, Sticherling M, Fell I, Handrick C, Schakel K, Staubach P, Asmussen A, Schwarz B, Bell M, Neubert K, Effendy I, Bieber T, Homey B, Gerlach B, Tchitcherina E, Stahl M, Schwichtenberg U, Rossbacher J, Buck P, Mempel M, Beissert S, Werfel T, Weidinger S, Schmitt J; TREATgermany study group. Implementation of dupilumab in routine care of atopic eczema: results from the German national registry TREATgermany. Br J Dermatol. 2020 Aug;183(2):382-384. doi: 10.1111/bjd.18958. Epub 2020 Apr 13. No abstract available.

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• Emmert H, Baurecht H, Thielking F, Stolzl D, Rodriguez E, Harder I, Proksch E, Weidinger S. Stratum corneum lipidomics analysis reveals altered ceramide profile in atopic dermatitis patients across body sites with correlated changes in skin microbiome. Exp Dermatol. 2021 Oct;30(10):1398-1408. doi: 10.1111/exd.14185. Epub 2020 Sep 17.

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• Baurecht H, Ruhlemann MC, Rodriguez E, Thielking F, Harder I, Erkens AS, Stolzl D, Ellinghaus E, Hotze M, Lieb W, Wang S, Heinsen-Groth FA, Franke A, Weidinger S. Epidermal lipid composition, barrier integrity, and eczematous inflammation are associated with skin microbiome configuration. J Allergy Clin Immunol. 2018 May;141(5):1668-1676.e16. doi: 10.1016/j.jaci.2018.01.019. Epub 2018 Feb 5.

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Related Links

• German Guidelines on Atopic Dermatitis

Biospecimen

Retention: SAMPLES WITH DNA

Skin swabs, tape strips.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stephan Weidinger, MD

  UKSH Kiel, University of Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Head, Department of Dermatology and Allergy

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: June 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)