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Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

Primary Purpose

Adenomatous Polyposis Coli

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Guselkumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Adenomatous Polyposis Coli

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2021
    Last Updated
    February 23, 2022
    Sponsor
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04948398
    Brief Title
    Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis
    Official Title
    Post-Trial Access for Guselkumab in Patients With Familial Adenomatous Polyposis Who Are Experiencing Clinical Benefit After Completing 48 Weeks of Treatment in CNTO1959COR1001
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    No longer 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
    Janssen Research & Development, LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study CNTO1959COR1001.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenomatous Polyposis Coli

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Guselkumab
    Intervention Description
    Guselkumab 100 milligrams (mg) will be administered subcutaneously once every 8 weeks.

    10. Eligibility

    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Research & Development, LLC Clinical Trial
    Organizational Affiliation
    Janssen Research & Development, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

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