This is a multi-center, expanded access protocol to provide access to the investigationalproduct, abrocitinib, to adolescent and adult patients with moderate to severe atopicdermatitis who have inadequate treatment options with available and approved medicatedtopical and systemic therapies and who are otherwise ineligible for participation inclinical studies with abrocitinib.
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.
Drug: abrocitinib
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by
the investigator's clinical judgement
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
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Allergy & Asthma Care Center
Long Beach, California, United States
ACRC Studies
San Diego, California, United States
Palm Beach Dermatology
Delray Beach, Florida, United States
Skin Care Research
Hollywood, Florida, United States
L&C Professional Medical Research Institute
Miami, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Dundee Dermatology
West Dundee, Illinois, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
Bluegrass Allergy Research
Lexington, Kentucky, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Hightower Clinical Trial Services - Lam Dermatology
Norman, Oklahoma, United States
Health Concepts
Rapid City, South Dakota, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States
Houston Medical Imaging
Houston, Texas, United States
West Virginia Research Institute
Morgantown, West Virginia, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Dr Rodney Sinclair Pty Ltd
Melbourne, Victoria, Australia
Sinclair Dermatology
Melbourne, Victoria, Australia
Paratus Clinical Research Woden
Philip, Australia
Medizinische Universität Wien
Vienna, Wien, Austria
Medical University of Vienna
Vienna, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
Grand Hôpital de Charleroi
Loverval, Belgium
Dermatology Research Institute
Calgary, Alberta, Canada
DermEffects
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Centre de recherche Saint-Louis
Quebec, Canada
401 General Military Hospital of Athens
Athens, Attikí, Greece
University General Hospital "ATTIKON"
Athens, Attikí, Greece
"Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
Thessaloniki, Kentrikí Makedonía, Greece
Centro de Dermatologia de Monterrey
Monterrey, Nuevo LEÓN, Mexico
Universitair Medisch Centrum (UMCU) Utrecht
Utrecht, Netherlands
NRC Institute of Immunology FMBA of Russia
Moscow, Russian Federation
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, LAS Palmas, Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
Pontevedra, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Universitätsspital Zürich
Zuerich, Zürich, Switzerland
Universitätsspital Zürich
Zuerich, Zürich, Switzerland
Inselspital, Universitätsklinik für Dermatologie
Bern, Switzerland
Inselspital, Universitätsspital Bern (Radiology)
Bern, Switzerland
University Hospital Geneva
Geneva 14, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Pfizer CT.gov Call Center, Study Director
Pfizer