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Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

Phase 2
Completed
Conditions
Asthma
Interventions
Drug: placebo
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboplaceboPatients 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).
RisankizumabrisankizumabPatients 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
NameTimeMethod
Time to First Asthma Worsening During the Planned 24 Week Treatment Period24 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
NameTimeMethod
Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition24 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 Period24 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 Period24 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 Period24 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 24Baseline 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 24Baseline 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 2424 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

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WCCT Global, LLC
🇺🇸Costa Mesa, California, United States

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