search
Back to results

Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)

Primary Purpose

Alopecia Areata

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

About this trial

This is an expanded access trial for Alopecia Areata focused on measuring Alopecia Areata (AA), Alopecia, Patchy AA, Alopecia Universalis (AU), Alopecia Totalis (AT), Ophiasis, Eyelash Loss, Eyebrow Loss, Hair Loss

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes
Must have ≥ 50% hair loss on scalp due to Alopecia Areata (AA) and be intolerant or have inadequate response to all commonly used AA therapies accessible in the country. Additional eligibility criteria may be required.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2022
    Last Updated
    September 5, 2023
    Sponsor
    Pfizer
    Collaborators
    In Expanded Access, treating physicians are the Sponsors
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05522556
    Brief Title
    Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)
    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 Sponsors

    4. Oversight

    5. Study Description

    Brief Summary
    Provide pre-approval single patient Expanded Access (compassionate use) of Ritlecitinib for patients.
    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
    Alopecia Areata
    Keywords
    Alopecia Areata (AA), Alopecia, Patchy AA, Alopecia Universalis (AU), Alopecia Totalis (AT), Ophiasis, Eyelash Loss, Eyebrow Loss, Hair Loss

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ritlecitinib
    Intervention Description
    capsules

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Eligibility Criteria
    Must have ≥ 50% hair loss on scalp due to Alopecia Areata (AA) and be intolerant or have inadequate response to all commonly used AA therapies accessible in the country. Additional eligibility criteria may be required.
    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 Ritlecitinib (PF-06651600)

    We'll reach out to this number within 24 hrs