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Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Available
Phase
Locations
International
Study Type
Expanded Access
Intervention
abrocitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema, expanded access

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cahaba Dermatology and Skin Health Center
  • Antelope Valley Clinical Trials
  • Allergy & Asthma Care Center
  • ACRC Studies
  • Palm Beach Dermatology
  • Skin Care Research
  • L&C Professional Medical Research Institute
  • Sarasota Clinical Research
  • Precision Clinical Research
  • Dundee Dermatology
  • Qualmedica Research, LLC
  • Bluegrass Allergy Research
  • Respiratory Medicine Research Institute of Michigan, PLC
  • Bexley Dermatology Research
  • Hightower Clinical Trial Services - Lam Dermatology
  • Health Concepts
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Center for Clinical Studies, LTD. LLP
  • Houston Medical Imaging
  • West Virginia Research Institute
  • Woden Dermatology
  • Royal North Shore Hospital
  • The Skin Centre
  • Sinclair Dermatology
  • Paratus Clinical Research Woden
  • Medizinische Universität Wien
  • Medical University of Vienna
  • Cliniques universitaires Saint-Luc
  • Universitair Ziekenhuis Gent
  • Grand Hôpital de Charleroi
  • Dermatology Research Institute
  • DermEffects
  • Lynderm Research Inc.
  • SKiN Centre for Dermatology
  • Centre de recherche Saint-Louis
  • 401 General Military Hospital of Athens
  • University General Hospital "ATTIKON"
  • "Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
  • Centro de Dermatologia de Monterrey
  • Universitair Medisch Centrum (UMCU) Utrecht
  • NRC Institute of Immunology FMBA of Russia
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario de Gran Canaria Doctor Negrín
  • Clinica Universidad de Navarra
  • Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
  • Consorcio Hospital General Universitario de Valencia
  • Universitätsspital Zürich
  • Universitätsspital Zürich
  • Inselspital, Universitätsklinik für Dermatologie
  • Inselspital, Universitätsspital Bern (Radiology)
  • University Hospital Geneva
  • Universitätsspital Zürich
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Chang Gung Memorial Hospital at Kaohsiung
  • Taipei Veterans General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 21, 2020
Last Updated
September 18, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04564755
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, eczema, expanded access

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
abrocitinib
Intervention Description
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Dermatology and Skin Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Available
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Available
Facility Name
Allergy & Asthma Care Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Individual Site Status
Available
Facility Name
ACRC Studies
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Individual Site Status
Available
Facility Name
Palm Beach Dermatology
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Available
Facility Name
Skin Care Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Available
Facility Name
L&C Professional Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Available
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Available
Facility Name
Precision Clinical Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Available
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Individual Site Status
Available
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Available
Facility Name
Bluegrass Allergy Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Available
Facility Name
Respiratory Medicine Research Institute of Michigan, PLC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Available
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Available
Facility Name
Hightower Clinical Trial Services - Lam Dermatology
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Individual Site Status
Available
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Available
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Available
Facility Name
Center for Clinical Studies, LTD. LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Available
Facility Name
Houston Medical Imaging
City
Houston
State/Province
Texas
ZIP/Postal Code
77072
Country
United States
Individual Site Status
Available
Facility Name
West Virginia Research Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Available
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Individual Site Status
Available
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Available
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Available
Facility Name
Sinclair Dermatology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3995
Country
Australia
Individual Site Status
Available
Facility Name
Paratus Clinical Research Woden
City
Philip
ZIP/Postal Code
2606
Country
Australia
Individual Site Status
Available
Facility Name
Medizinische Universität Wien
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Available
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Available
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Available
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Available
Facility Name
Grand Hôpital de Charleroi
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Individual Site Status
Available
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Available
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Available
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Individual Site Status
Available
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Available
Facility Name
Centre de recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Available
Facility Name
401 General Military Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
11525
Country
Greece
Individual Site Status
Available
Facility Name
University General Hospital "ATTIKON"
City
Athens
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Available
Facility Name
"Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
City
Thessaloniki
State/Province
Kentrikí Makedonía
ZIP/Postal Code
54643
Country
Greece
Individual Site Status
Available
Facility Name
Centro de Dermatologia de Monterrey
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Available
Facility Name
Universitair Medisch Centrum (UMCU) Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Available
Facility Name
NRC Institute of Immunology FMBA of Russia
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Available
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Available
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrín
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Available
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Available
Facility Name
Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Individual Site Status
Available
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Available
Facility Name
Universitätsspital Zürich
City
Zuerich
State/Province
Zürich
ZIP/Postal Code
8052
Country
Switzerland
Individual Site Status
Available
Facility Name
Universitätsspital Zürich
City
Zuerich
State/Province
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Available
Facility Name
Inselspital, Universitätsklinik für Dermatologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Available
Facility Name
Inselspital, Universitätsspital Bern (Radiology)
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Available
Facility Name
University Hospital Geneva
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Available
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Available
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Available
Facility Name
Chang Gung Memorial Hospital at Kaohsiung
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Available
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Available

12. IPD Sharing Statement

Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7451064
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

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