Clinical trial NCT04564755: Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
Official title: ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
eczema
expanded access
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology and Skin Health Center
state: Alabama
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Care Center
state: California
city: Long Beach
country: United States
facility: Beach Allergy and Asthma Specialty Group, A Medical Corporation
state: California
city: San Diego
country: United States
facility: ACRC Studies
state: California
city: Delray Beach
country: United States
facility: Palm Beach Dermatology
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Allergy Research
state: Kentucky
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Norman
country: United States
facility: Hightower Clinical Trial Services - Lam Dermatology
state: Oklahoma
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Tennessee
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Houston
country: United States
facility: Houston Medical Imaging
state: Texas
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
state: Victoria
city: Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Philip
country: Australia
facility: Paratus Clinical Research Woden
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Loverval
country: Belgium
facility: Grand Hôpital de Charleroi
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Quebec
country: Canada
facility: Centre de recherche Saint-Louis
city: Athens
country: Greece
facility: 401 General Military Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: University General Hospital "ATTIKON"
state: Attikí
city: Thessaloniki
country: Greece
facility: "Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
state: Kentrikí Makedonía
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo LEÓN
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum (UMCU) Utrecht
city: Moscow
country: Russian Federation
facility: NRC Institute of Immunology FMBA of Russia
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: LAS Palmas
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Zuerich
country: Switzerland
facility: Universitätsspital Zürich
state: Zürich
city: Zuerich
country: Switzerland
facility: Universitätsspital Zürich
state: Zürich
city: Bern
country: Switzerland
facility: Inselspital, Universitätsklinik für Dermatologie
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern (Radiology)
city: Geneva 14
country: Switzerland
facility: University Hospital Geneva
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: