AbbVie

Expanded Access to Risankizumab

Official Title: 
Expanded Access to Risankizumab
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. Participating sites will be added as they apply for and are approved for the EAP. 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.
Available
EA Type
Individual Patients
Crohn's Disease

Drug: Risankizumab
Risankizumab will be administered as intravenous (IV) or subcutaneous (SC) injection.
Other Name: ABBV-066
Other Name: BI 655066

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 18 Years
Contacts: 

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

AbbVie Inc.
Study Director
AbbVie

EA Number: 
Keywords: 
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
MeSH Terms: 
Crohn Disease, Antibodies, Monoclonal
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.