Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
- Registration Number
- NCT02443298
- Lead Sponsor
- AbbVie
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20). Risankizumab risankizumab Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).
- Primary Outcome Measures
Name Time Method Time to First Asthma Worsening During the Planned 24 Week Treatment Period 24 weeks Time to first asthma worsening during the planned 24 week treatment period:
Asthma worsening was defined as the occurrence of any one of the following four criteria:
a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
- Secondary Outcome Measures
Name Time Method Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition 24 weeks Time to first asthma worsening during the planned 24 week treatment period according to alternative definition:
Asthma worsening was defined as the occurrence of any one of the following four criteria:
a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.5 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period 24 weeks Annualized rate of asthma worsening during the planned 24 week treatment period.
Asthma worsening was defined as the occurrence of any one of the following four criteria:
a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Mean is Annualized rate.Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period 24 weeks Time to first severe asthma exacerbation during the planned 24 week treatment period. Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period 24 weeks Annualized rate of severe asthma exacerbation during the planned 24-week treatment period.
Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Mean is Annualized rate.Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24 Baseline and 24 weeks Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24 Baseline and 24 weeks Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Weekly Asthma Control Questionaire Score at Week 24 24 weeks The score at week 24 is the average of the responses to the five ACQ5 questions for the week preceding the Week 24 visit. The ACQ5 asks patients to rate the severity of their asthma symptoms and the degree to which asthma affected their sleep and other daily activities. The scale for all five ACQ5 questions range from the best possible answer of 0 (No symptoms, None, Never) to the worst possible answer of 6 (very severe, unable to sleep, totally limited). The ACQ5 score can range from 0.0 (best) to 6.0 (worst).
Trial Locations
- Locations (64)
WCCT Global, LLC
🇺🇸Costa Mesa, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Clinical Research Trials of Florida, Inc.
🇺🇸Tampa, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
VA WNY Healthcare System
🇺🇸Buffalo, New York, United States
Scroll for more (54 remaining)WCCT Global, LLC🇺🇸Costa Mesa, California, United States