Clinical trial NCT02443298: Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
Official title: Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2015-05-13
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion criteria:

1. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
2. 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.
3. Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
4. Must have documented history of two or more severe asthma exacerbations in the last 12 months.

Exclusion criteria:

1. Patients with a significant disease other than asthma.
2. Patients who are not able to produce sputum or sputum samples of sufficient quality.
3. Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
4. Patients diagnosed with any concurrent respiratory disease.
5. Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
6. Patients who have undergone thoracotomy with pulmonary resection.
7. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
8. Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
9. Pregnant or nursing women.
10. Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
11. Clinically relevant acute infections or chronic infections.
12. Have received any live bacterial or live viral vaccination in the last12 weeks.
13. Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
14. Have received treatment with ustekinumab (Stelara®).
15. Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.

Primary outcomes:
measure: Time to First Asthma Worsening During the Planned 24 Week Treatment Period
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
timeFrame: 24 weeks
measure: Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
timeFrame: 24 weeks
measure: Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period
timeFrame: 24 weeks
measure: Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period
timeFrame: 24 weeks
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
timeFrame: Baseline and 24 weeks
measure: Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
timeFrame: Baseline and 24 weeks
measure: Weekly Asthma Control Questionaire Score at Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: WCCT Global, LLC
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Buffalo
country: United States
facility: VA WNY Healthcare System
state: New York
city: Charlotte
country: United States
facility: American Health Research, Inc.
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Mgmt Spc
state: Pennsylvania
city: Columbia
country: United States
facility: MedTrial, LLC
state: South Carolina
city: Greenville
country: United States
facility: VitaLink Research
state: South Carolina
city: The Woodlands
country: United States
facility: Respiratory and Sleep Disorders Specialists
state: Texas
city: Fairfax
country: United States
facility: O and O Alpan, LLC
state: Virginia
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Bruxelles
country: Belgium
facility: Brussels - UNIV St-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Burlington
country: Canada
facility: Burlington Lung Clinic
state: Ontario
city: Hamilton
country: Canada
facility: Airway Inflammometry Laboratory
state: Ontario
city: Grenoble
country: France
facility: HOP CHU de Grenoble
city: Marseille
country: France
facility: HOP Nord
city: Montpellier
country: France
facility: HOP Arnaud de Villeneuve
city: Nantes
country: France
facility: HOP Nord Laënnec
city: Paris
country: France
facility: HOP Bichat
city: Berlin
country: Germany
facility: Praxis Dr. Linnhoff, Berlin
city: Berlin
country: Germany
facility: MECS Research GmbH, Berlin
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
city: Frankfurt
country: Germany
facility: Praxis Dr. med. Claus Keller
city: Frankfurt
country: Germany
facility: IKF Pneumologie GmbH & Co. KG
city: Frankfurt
country: Germany
facility: Medaimun GmbH
city: Hamburg
country: Germany
facility: Hamburger Institut für Therapieforschung GmbH (HIT)
city: Hannover
country: Germany
facility: Praxis Dr. Hoffmann, Hannover
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Koblenz
country: Germany
facility: KPPK GmbH, Studienzentrum
city: Lübeck
country: Germany
facility: KLB Gesundheitsforschung Lübeck GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Neu-Isenburg
country: Germany
facility: Institut für klinische Forschung GmbH
city: Rüdersdorf
country: Germany
facility: IFG Institut für Gesundheitsförderung GmbH
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St.Paul's Hospital
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Katowice
country: Poland
facility: Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat
city: Krakow
country: Poland
facility: Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED
city: Krakow
country: Poland
facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept
city: Lodz
country: Poland
facility: Barlicki University Hospital No. 1
city: Lodz
country: Poland
facility: Barlicki University Hospital No. 1
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital Keelung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Belfast
country: United Kingdom
facility: Celerion Inc
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.