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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
Pfizer
About
Eligibility
Locations
Outcomes
Full info

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

12 Years - undefined (Child, Adult, Older Adult)All Sexes
Must have severe uncontrolled atopic dermatitis refractory to other available treatments

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 22, 2022
    Last Updated
    September 19, 2023
    Sponsor
    Pfizer
    Collaborators
    In Expanded Access, treating physicians are the Sponsor
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    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
    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
    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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