Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma (NCT02443298) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
United States214 participantsStarted 2015-06-23
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
✓. One year history of asthma diagnosed by a physician, and have FEV1 reversibility of =12% and an absolute change of at least 200 mL after administration of 400 µg salbutamol.
✓. Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
✓. Must have documented history of two or more severe asthma exacerbations in the last 12 months.
Exclusion criteria
✕. Patients with a significant disease other than asthma.
✕. Patients who are not able to produce sputum or sputum samples of sufficient quality.
✕. Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
✕. Patients diagnosed with any concurrent respiratory disease.
✕
What they're measuring
1
Time to First Asthma Worsening During the Planned 24 Week Treatment Period