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

October 28, 2024 updated by: Pfizer

ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

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

Study Locations

  • Australia
      • Philip, Australia, 2606
        • Paratus Clinical Research Woden
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3995
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Victoria, Australia, 3995
        • Sinclair Dermatology
  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Loverval, Belgium, 6280
        • Grand Hôpital de Charleroi
  • Canada
      • Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • DermEffects
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc.
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Centre for Dermatology
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 11525
        • 401 General Military Hospital of Athens
      • Athens, Attikí, Greece, 12462
        • University General Hospital "Attikon"
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Greece, 54643
        • "Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
  • Mexico
    • Nuevo LEÓN
      • Monterrey, Nuevo LEÓN, Mexico, 64460
        • Centro de Dermatologia de Monterrey
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum (UMCU) Utrecht
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • NRC Institute of Immunology FMBA of Russia
  • Spain
      • Pontevedra, Spain, 36001
        • Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsklinik für Dermatologie
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern (Radiology)
      • Geneva 14, Switzerland, 1211
        • University Hospital Geneva
      • Zürich, Switzerland, CH-8091
        • UniversitätsSpital Zürich
    • Zürich
      • Zuerich, Zürich, Switzerland, 8052
        • UniversitätsSpital Zürich
      • Zuerich, Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology and Skin Health Center
    • California
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
      • Long Beach, California, United States, 90808
        • Allergy & Asthma Care Center
      • Long Beach, California, United States, 90808
        • Beach Allergy and Asthma Specialty Group, A Medical Corporation
      • San Diego, California, United States, 92119
        • ACRC Studies
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Palm Beach Dermatology
      • Hollywood, Florida, United States, 33021
        • Skin Care Research
      • Miami, Florida, United States, 33144
        • L&C Professional Medical Research Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
    • Illinois
      • West Dundee, Illinois, United States, 60118
        • Dundee Dermatology
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Allergy Research
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan, PLC
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Hightower Clinical Trial Services - Lam Dermatology
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Texas
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies, LTD. LLP
      • Houston, Texas, United States, 77072
        • Houston Medical Imaging
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia Research Institute

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 systemic therapies 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 Criteria:

  • Medical, psychiatric, or laboratory abnormality that may increase the risk associated with study participation
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders 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 or tolerability issues
  • 12 to <18 years old without documented evidence of having received at least one dose of the varicella vaccine or without evidence of prior exposure to varicella zoster virus based on serological test
  • Pregnant or breastfeeding women or women of childbearing potential who are sexually active and unwilling to use contraception

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?

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

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.

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 Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7451064
  • 2020-003610-12 (EudraCT Number)
  • JADE REAL (Other Identifier: Alias Study Number)

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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