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Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.

Primary Purpose

Colitis, Ulcerative

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

About this trial

This is an expanded access trial for Colitis, Ulcerative focused on measuring Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Patient must be intolerant, have a contraindication or had inadequate response to at least 3 therapies available for Ulcerative Colitis (UC) in this country or provide a rationale of why therapy was not used.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Pfizer
    Collaborators
    In Expanded Access, treating physicians are the Sponsors
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06025227
    Brief Title
    Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 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 Etrasimod for patients.
    Detailed Description
    Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colitis, Ulcerative
    Keywords
    Ulcerative Colitis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Etrasimod
    Intervention Description
    tablets

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Patient must be intolerant, have a contraindication or had inadequate response to at least 3 therapies available for Ulcerative Colitis (UC) in this country or provide a rationale of why therapy was not used.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    PfizerCares
    Email
    PfizerCares@Pfizer.com

    12. IPD Sharing Statement

    Learn more about this trial

    Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.

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