Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

Last updated: October 28, 2024
Sponsor: Pfizer
Overall Status: Trial Not Available

Phase

N/A

Condition

Atopic Dermatitis

Skin Infections/disorders

Rosacea

Treatment

abrocitinib

Clinical Study ID

NCT04564755
B7451064
JADE REAL
2020-003610-12
  • Ages > 12
  • All Genders

Study Summary

This is a multi-center, expanded access protocol to provide access to the investigational product, abrocitinib, to adolescent and adult patients with moderate to severe atopic dermatitis who have inadequate treatment options with available and approved medicated topical and systemic therapies and who are otherwise ineligible for participation in clinical studies with abrocitinib.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 12 years of age or older

  • Clinical diagnosis of chronic atopic dermatitis for at least 6 months

  • Inadequate treatment options with available, approved medicated topical and systemictherapies for moderate to severe atopic dermatitis

  • Moderate to severe atopic dermatitis as indicated by at least one of the following:IGA ≥3; EASI ≥16

  • Not eligible for participation in any ongoing clinical trial of abrocitinib,including lack of access due to geographical limitations

Exclusion

Exclusion Criteria:

  • Medical, psychiatric, or laboratory abnormality that may increase the riskassociated with study participation

  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,malignancies, current or history of certain infections, lymphoproliferativedisorders and other medical conditions at the discretion of the investigator

  • Require treatment with prohibited medications during the study

  • Discontinued prior treatment with any systemic JAK inhibitor due to safety ortolerability issues

  • 12 to <18 years old without documented evidence of having received at least one doseof the varicella vaccine or without evidence of prior exposure to varicella zostervirus based on serological test

  • Pregnant or breastfeeding women or women of childbearing potential who are sexuallyactive and unwilling to use contraception

Study Design

Treatment Group(s): 1
Primary Treatment: abrocitinib
Phase:
Study Start date:
Estimated Completion Date:

Study Description

This is a multi-center expanded access protocol (EAP) for the treatment of up to approximately 500 adult and adolescent (defined as age < 18 years) patients with moderate to severe atopic dermatitis for whom standard, approved medicated topical and systemic treatment options are inadequate and who would be suitable candidates for a trial of abrocitinib for potential treatment of moderate to severe atopic dermatitis. The study will also collect safety and exploratory efficacy data. Participants who meet the inclusion criteria and none of the exclusion criteria may be enrolled into the EAP to receive open-label oral treatment with abrocitinib.

Connect with a study center

  • Woden Dermatology

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • The Skin Centre

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Dr Rodney Sinclair Pty Ltd

    Melbourne, Victoria 3995
    Australia

    Site Not Available

  • Sinclair Dermatology

    Melbourne, Victoria 3995
    Australia

    Site Not Available

  • Paratus Clinical Research Woden

    Philip, 2606
    Australia

    Site Not Available

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Oberösterreich 4020
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Planned

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi

    Loverval, 6280
    Belgium

    Site Not Available

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • DermEffects

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • SKiN Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Centre de recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • 401 General Military Hospital of Athens

    Athens, Attikí 11525
    Greece

    Site Not Available

  • University General Hospital "ATTIKON"

    Athens, Attikí 12462
    Greece

    Site Not Available

  • "Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener

    Thessaloniki, Kentrikí Makedonía 54643
    Greece

    Site Not Available

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo LEÓN 64460
    Mexico

    Site Not Available

  • Universitair Medisch Centrum (UMCU) Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Limited Liability Company "Medical Center Azbuka Zdorovya" ("MC Azbuka Zdorovya" LLC)

    Kazan, Tatarstan Republic 420111
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"

    Chelyabinsk, 454092
    Russian Federation

    Site Not Available

  • NRC Institute of Immunology FMBA of Russia

    Moscow, 115522
    Russian Federation

    Site Not Available

  • FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF

    Saint-Petersburg, 194100
    Russian Federation

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, LAS Palmas 35010
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao

    Pontevedra, 36001
    Spain

    Site Not Available

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Universitätsspital Zürich

    Zuerich, Zürich 8091
    Switzerland

    Site Not Available

  • Inselspital, Universitätsklinik für Dermatologie

    Bern, 3010
    Switzerland

    Site Not Available

  • Inselspital, Universitätsspital Bern (Radiology)

    Bern, 3010
    Switzerland

    Site Not Available

  • University Hospital Geneva

    Geneva 14, 1211
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, CH-8091
    Switzerland

    Site Not Available

  • Universitätsspital Zürich Flughafen

    Zürich-Flughafen, 8058
    Switzerland

    Site Not Available

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • Cahaba Dermatology and Skin Health Center

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Arizona Allergy & Immunology Research

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Site Not Available

  • Allergy & Asthma Care Center

    Long Beach, California 90808
    United States

    Site Not Available

  • Beach Allergy and Asthma Specialty Group, A Medical Corporation

    Long Beach, California 90808
    United States

    Site Not Available

  • ACRC Studies

    San Diego, California 92119
    United States

    Site Not Available

  • Uconn Health

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Palm Beach Dermatology

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Skin Care Research

    Hollywood, Florida 33021
    United States

    Site Not Available

  • L&C Professional Medical Research Institute

    Miami, Florida 33144
    United States

    Site Not Available

  • Sarasota Clinical Research

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • Dundee Dermatology

    West Dundee, Illinois 60118
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Bluegrass Allergy Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Cleaver Dermatology

    Kirksville, Missouri 63501
    United States

    Site Not Available

  • J Woodson Clinical Studies Group

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Hightower Clinical Trial Services - Lam Dermatology

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • Houston Medical Imaging

    Houston, Texas 77072
    United States

    Site Not Available

  • West Virginia Research Institute

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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