Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)
Primary Purpose
Severe Uncontrolled Atopic Dermatitis
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
abrocitinib
Sponsored by
About this trial
This is an expanded access trial for Severe Uncontrolled Atopic Dermatitis focused on measuring atopic dermatitis, AD, Atopic eczema, JAK inhibitors
Eligibility Criteria
Must have severe uncontrolled atopic dermatitis refractory to other available treatments
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05466578
First Posted
June 22, 2022
Last Updated
September 19, 2023
Sponsor
Pfizer
Collaborators
In Expanded Access, treating physicians are the Sponsor
1. Study Identification
Unique Protocol Identification Number
NCT05466578
Brief Title
Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
In Expanded Access, treating physicians are the Sponsor
4. Oversight
5. Study Description
Brief Summary
Provide pre-approval single patient Expanded Access (compassionate use) of abrocitinib for patients with severe uncontrolled atopic dermatitis
Detailed Description
Expanded Access requests from treating physicians may be submitted at www.pfizercares.com ; availability will depend on location/country.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Uncontrolled Atopic Dermatitis
Keywords
atopic dermatitis, AD, Atopic eczema, JAK inhibitors
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
abrocitinib
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
Must have severe uncontrolled atopic dermatitis refractory to other available treatments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer Cares
Email
pfizercares@pfizer.com
12. IPD Sharing Statement
Learn more about this trial
Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)
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