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Expanded Access to Risankizumab

NCT ID: NCT03914261

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease Ulcerative Colitis (UC)

Interventions

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Risankizumab

Tablet

Intervention Type DRUG

Other Intervention Names

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ABBV-066 BI 655066

Eligibility Criteria

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Minimum Eligible Age

18 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

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C19-882

Identifier Type: -

Identifier Source: org_study_id

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