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Expanded Access to Risankizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03914261
Expanded Access Status : Available
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Crohn's Disease Drug: Risankizumab

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access to Risankizumab

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03914261

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Contact: ABBVIE CALL CENTER 847.283.8955

Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie Identifier: NCT03914261     History of Changes
Other Study ID Numbers: C19-882
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs