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NCT03914261 Clinical Trial

Expanded Access to Risankizumab

Crohn's Disease Clinical Trial

Official title:
Expanded Access to Risankizumab

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03914261
Other study ID # C19-882
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date May 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Risankizumab
Tablet

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AbbVie
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