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Expanded Access to Risankizumab

Primary Purpose

Crohn's Disease, Ulcerative Colitis (UC)

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Risankizumab
Sponsored by
AbbVie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Crohn's Disease focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Does not accept healthy volunteers

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2019
    Last Updated
    May 20, 2022
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03914261
    Brief Title
    Expanded Access to Risankizumab
    Official Title
    Expanded Access to Risankizumab
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 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
    AbbVie

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program (EAP) for eligible participants with Crohn's Disease (CD). This program is designed to provide access to risankizumab, prior to approval by the local regulatory agency, to patients with the highest unmet need and an urgent need for treatment, where risankizumab may prolong survival, prevent occurrence of clinical events associated with significant morbidity and/or mortality, or stabilize a progressive debilitating disease. Availability will depend on a review of the eligibility of the patient and local approval status of risankizumab for CD. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease, Ulcerative Colitis (UC)
    Keywords
    Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Risankizumab
    Other Intervention Name(s)
    ABBV-066, BI 655066
    Intervention Description
    Tablet

    10. Eligibility

    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AbbVie Inc.
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Risankizumab

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