Expanded Access to Risankizumab
NCT03914261 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2022-05-24
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.
Conditions
- Crohn's Disease
- Ulcerative Colitis (UC)
Interventions
- DRUG
-
Tablet
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AbbVie Inc. · AbbVie
Eligibility
- Min Age
- 18 Years
- Sex
- Healthy Volunteers
- No
Timeline & Regulatory
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