Official Title
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.

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.

Treatment IND/Protocol
Atopic Dermatitis

Drug: abrocitinib

Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement

Eligibility Criteria

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

Eligibility Gender
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Russian Federation
United States

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

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

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 Call Center

Pfizer Call Center, Study Director

NCT Number
atopic dermatitis
Expanded Access
MeSH Terms
Dermatitis, Atopic