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

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: placebo
Drug: risankizumab

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

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): Wishaw General Hospital
🇬🇧
Wishaw, United Kingdom
HagaZiekenhuis
🇳🇱
Den Haag, Netherlands
Univ. Hospital in Krakow,Pulmonology Clinical Dept
🇵🇱
Krakow, Poland
Leids Universitair Medisch Centrum (LUMC)
🇳🇱
Leiden, Netherlands
Vancouver General Hospital
🇨🇦
Vancouver, British Columbia, Canada
Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED
🇵🇱
Krakow, Poland
Brussels - UNIV St-Luc
🇧🇪
Bruxelles, Belgium
Centre Hospitalier Universitaire de Liège
🇧🇪
Liège, Belgium
Barlicki University Hospital No. 1
🇵🇱
Lodz, Poland
China Medical University Hospital
🇨🇳
Taichung, Taiwan
IMMUNOe Research Centers
🇺🇸
Centennial, Colorado, United States
HOP Arnaud de Villeneuve
🇫🇷
Montpellier, France
Coastal Carolina Health Care, P.A.
🇺🇸
New Bern, North Carolina, United States
ULB Hopital Erasme
🇧🇪
Bruxelles, Belgium
VitaLink Research
🇺🇸
Greenville, South Carolina, United States
HOP Nord
🇫🇷
Marseille, France
Airway Inflammometry Laboratory
🇨🇦
Hamilton, Ontario, Canada
UZ Leuven
🇧🇪
Leuven, Belgium
MECS Research GmbH, Berlin
🇩🇪
Berlin, Germany
Praxis Dr. Linnhoff, Berlin
🇩🇪
Berlin, Germany
HOP Nord Laënnec
🇫🇷
Nantes, France
Universitätsklinikum des Saarlandes
🇩🇪
Homburg/Saar, Germany
Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat
🇵🇱
Katowice, Poland
Chang Gung Memorial Hospital Keelung
🇨🇳
Keelung, Taiwan
KPPK GmbH, Studienzentrum
🇩🇪
Koblenz, Germany
The Catholic University of Korea, St.Paul's Hospital
🇰🇷
Seoul, Korea, Republic of
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
🇩🇪
Bochum, Germany
Praxis Dr. med. Claus Keller
🇩🇪
Frankfurt, Germany
IKF Pneumologie GmbH & Co. KG
🇩🇪
Frankfurt, Germany
Medaimun GmbH
🇩🇪
Frankfurt, Germany
Praxis Dr. Hoffmann, Hannover
🇩🇪
Hannover, Germany
Institut für klinische Forschung GmbH
🇩🇪
Neu-Isenburg, Germany
WCCT Global, LLC
🇺🇸
Costa Mesa, California, United States
El Camino Hospital
🇺🇸
Mountain View, California, United States
Research Protocol Mgmt Spc
🇺🇸
Pittsburgh, Pennsylvania, United States
O and O Alpan, LLC
🇺🇸
Fairfax, Virginia, United States
Clinical Research Trials of Florida, Inc.
🇺🇸
Tampa, Florida, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
MedTrial, LLC
🇺🇸
Columbia, South Carolina, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Respiratory and Sleep Disorders Specialists
🇺🇸
The Woodlands, Texas, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Wake Forest School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
American Health Research, Inc.
🇺🇸
Charlotte, North Carolina, United States
VA WNY Healthcare System
🇺🇸
Buffalo, New York, United States
Temple University School of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Burlington Lung Clinic
🇨🇦
Burlington, Ontario, Canada
HOP Bichat
🇫🇷
Paris, France
HOP CHU de Grenoble
🇫🇷
Grenoble, France
Hamburger Institut für Therapieforschung GmbH (HIT)
🇩🇪
Hamburg, Germany
KLB Gesundheitsforschung Lübeck GmbH
🇩🇪
Lübeck, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪
Kiel, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪
Mainz, Germany
IFG Institut für Gesundheitsförderung GmbH
🇩🇪
Rüdersdorf, Germany
Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷
Cheongju, Korea, Republic of
Chonnam National University Hospital
🇰🇷
Gwangju, Korea, Republic of
Glenfield Hospital
🇬🇧
Leicester, United Kingdom
The Medicines Evaluation Unit
🇬🇧
Manchester, United Kingdom
Celerion Inc
🇬🇧
Belfast, United Kingdom
Bradford Royal Infirmary
🇬🇧
Bradford, United Kingdom
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States