Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
Study Identifier
1311.14
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 2
Sex
Female & Male
Age
18 - 75 Years
Protocol Summary
The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).
Study Locations
Location
Status
Location
WCCT Global, LLC
Costa Mesa, California, United States, 92626
Status
Not applicable
Location
El Camino Hospital
Mountain View, California, United States, 94040
Status
Not applicable
Location
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
Status
Not applicable
Location
Yale New Haven Hospital
New Haven, Connecticut, United States, 06504
Status
Not applicable
Location
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States, 33607
Status
Not applicable
Location
Northwestern University
Chicago, Illinois, United States, 60611
Status
Not applicable
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