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
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
undefined (undefined)
Study Completion Date
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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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