drugset / Trial / NCT03914261

Expanded Access to Risankizumab

NCT03914261

Expanded access No longer available AbbVie

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Background Risankizumab Monoclonal antibody