Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
3 other identifiers
expanded_access
N/A
11 countries
55
Brief 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.
Trial Health
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55 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedOctober 29, 2024
October 1, 2024
September 21, 2020
October 28, 2024
Conditions
Keywords
Interventions
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (57)
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244, United States
Antelope Valley Clinical Trials
Lancaster, California, 93534, United States
Allergy & Asthma Care Center
Long Beach, California, 90808, United States
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach, California, 90808, United States
ACRC Studies
San Diego, California, 92119, United States
Palm Beach Dermatology
Delray Beach, Florida, 33484, United States
Skin Care Research
Hollywood, Florida, 33021, United States
L&C Professional Medical Research Institute
Miami, Florida, 33144, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Bluegrass Allergy Research
Lexington, Kentucky, 40509, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Hightower Clinical Trial Services - Lam Dermatology
Norman, Oklahoma, 73072, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
Houston Medical Imaging
Houston, Texas, 77072, United States
West Virginia Research Institute
Morgantown, West Virginia, 26505, United States
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Dr Rodney Sinclair Pty Ltd
Melbourne, Victoria, 3995, Australia
Sinclair Dermatology
Melbourne, Victoria, 3995, Australia
Paratus Clinical Research Woden
Philip, 2606, Australia
Medizinische Universität Wien
Vienna, Vienna, 1090, Austria
Medical University of Vienna
Vienna, 1090, Austria
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Grand Hôpital de Charleroi
Loverval, 6280, Belgium
Dermatology Research Institute
Calgary, Alberta, T2J 7E1, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X3, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Centre de recherche Saint-Louis
Québec, G1W 4R4, Canada
401 General Military Hospital of Athens
Athens, Attikí, 11525, Greece
University General Hospital "ATTIKON"
Athens, Attikí, 12462, Greece
"Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
Thessaloniki, Kentrikí Makedonía, 54643, Greece
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, 64460, Mexico
Universitair Medisch Centrum (UMCU) Utrecht
Utrecht, 3584 CX, Netherlands
NRC Institute of Immunology FMBA of Russia
Moscow, 115522, Russia
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
Pontevedra, 36001, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Universitätsspital Zürich
Zurich, Canton of Zurich, 8052, Switzerland
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091, Switzerland
Inselspital, Universitätsklinik für Dermatologie
Bern, 3010, Switzerland
Inselspital, Universitätsspital Bern (Radiology)
Bern, 3010, Switzerland
University Hospital Geneva
Geneva, 1211, Switzerland
Universitätsspital Zürich
Zurich, CH-8091, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 83301, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer