Atopic Dermatitis Clinical Trial
Official title:
ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
NCT number | NCT04564755 |
Other study ID # | B7451064 |
Secondary ID | 2020-003610-12JA |
Status | No longer available |
Phase | |
First received | |
Last updated |
Verified date | June 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
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.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 | Woden Dermatology | Phillip | Australian Capital Territory |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Austria | Medical University of Vienna | Vienna | |
Austria | Medizinische Universität Wien | Vienna | Wien |
Belgium | Cliniques universitaires Saint-Luc | Brussels | |
Belgium | Universitair Ziekenhuis Gent | Gent | |
Belgium | Grand Hôpital de Charleroi | Loverval | |
Canada | 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 | |
Greece | 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 |
Mexico | Centro de Dermatologia de Monterrey | Monterrey | Nuevo LEÓN |
Netherlands | Universitair Medisch Centrum (UMCU) Utrecht | Utrecht | |
Russian Federation | NRC Institute of Immunology FMBA of Russia | Moscow | |
Spain | 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 | |
Switzerland | Inselspital, Universitätsklinik für Dermatologie | Bern | |
Switzerland | Inselspital, Universitätsspital Bern (Radiology) | Bern | |
Switzerland | University Hospital Geneva | Geneva 14 | |
Switzerland | Universitätsspital Zürich | Zuerich | Zürich |
Switzerland | Universitätsspital Zürich | Zuerich | Zürich |
Switzerland | Universitätsspital Zürich | Zürich | |
Taiwan | Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung | |
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
United States | Bexley Dermatology Research | Bexley | Ohio |
United States | Cahaba Dermatology and Skin Health Center | Birmingham | Alabama |
United States | Palm Beach Dermatology | Delray Beach | Florida |
United States | Qualmedica Research, LLC | Evansville | Indiana |
United States | Skin Care Research | Hollywood | Florida |
United States | Center for Clinical Studies, LTD. LLP | Houston | Texas |
United States | Houston Medical Imaging | Houston | Texas |
United States | Antelope Valley Clinical Trials | Lancaster | California |
United States | Bluegrass Allergy Research | Lexington | Kentucky |
United States | Allergy & Asthma Care Center | Long Beach | California |
United States | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee |
United States | L&C Professional Medical Research Institute | Miami | Florida |
United States | West Virginia Research Institute | Morgantown | West Virginia |
United States | Hightower Clinical Trial Services - Lam Dermatology | Norman | Oklahoma |
United States | Health Concepts | Rapid City | South Dakota |
United States | ACRC Studies | San Diego | California |
United States | Sarasota Clinical Research | Sarasota | Florida |
United States | Precision Clinical Research | Sunrise | Florida |
United States | Dundee Dermatology | West Dundee | Illinois |
United States | Respiratory Medicine Research Institute of Michigan, PLC | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Austria, Belgium, Canada, Greece, Mexico, Netherlands, Russian Federation, Spain, Switzerland, Taiwan,
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