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
  • Asthma
  • Study Drug
  • placebo
  • risankizumab
  • 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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