Clinical trial NCT01902290: Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Inadequately controlled asthma, brodalumab, AMG 827
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
name: AstraZeneca
First posted: 2013-07-18
Enrollment: 421
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 purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 20% at screening
* Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
* Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points

Exclusion Criteria:

* History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
* History of allergic bronchopulmonary aspergillosis
* Respiratory infection within 4 weeks of screening or 1 week of baseline visit
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
* Subject has previously used any anti-interleukin-17 (IL17) biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
* Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
* Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety

Primary outcomes:
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Asthma Exacerbation Rate
timeFrame: Baseline to week 24
measure: Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation
timeFrame: Baseline and week 24
measure: Asthma Exacerbation Rate in ICS+LABA Subpopulation
timeFrame: Baseline to week 24
measure: Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)
timeFrame: Baseline and week 24
measure: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and week 24
measure: Change From Baseline in Daily Rescue Short-acting Beta-agonist Use
timeFrame: Baseline and week 24
measure: Time to First Asthma Exacerbation
timeFrame: From first dose of study drug to week 24
measure: Number of Participants Who Experienced an Asthma Exacerbation
timeFrame: Baseline to week 24
measure: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score
timeFrame: Baseline and week 24
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)
timeFrame: Baseline and week 24
measure: Change From Baseline in Variation of Peak Flow
timeFrame: Baseline and week 24
measure: Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period
timeFrame: Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24
measure: Serum Brodalumab Concentration
timeFrame: Day 1 and weeks 1, 2, 4, 8, 12, 16, and 22 at predose, week 2 + 3 days, week 22 + 3, 7, 10, and 14 days
Other outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to the end of study, 28 weeks
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: North Hollywood
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Palmdale
country: United States
facility: Research Site
state: California
city: Rolling Hills Estates
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Lynn Haven
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Eagle
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Saint Louis
country: United States
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state: Missouri
city: Bellevue
country: United States
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state: Nebraska
city: Ocean City
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Rochester
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dublin
country: United States
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state: Ohio
city: Middleburg Heights
country: United States
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state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: Rock Hill
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: El Paso
country: United States
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state: Texas
city: McKinney
country: United States
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state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Clinton
country: United States
facility: Research Site
state: Utah
city: Bellingham
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: New Lambton
country: Australia
facility: Research Site
state: New South Wales
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Sherwood Park
country: Canada
facility: Research Site
state: Alberta
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Sarnia
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Trois Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Le Kremlin Bicetre
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier cedex 05
country: France
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
city: Saint Herblain
country: France
facility: Research Site
city: Strasbourg cedex
country: France
facility: Research Site
city: Tours Cedex 9
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Radebeul
country: Germany
facility: Research Site
city: Rüdersdorf
country: Germany
facility: Research Site
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chaidari, Athens
country: Greece
facility: Research Site
city: Heraklion - Crete
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: New Territories
country: Hong Kong
facility: Research Site
city: Cork
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Ferrara
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Tradate (VA)
country: Italy
facility: Research Site
city: Bucheon-si, Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Wonju-si, Gangwon-do
country: Korea, Republic of
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Dunedin
country: New Zealand
facility: Research Site
city: Remuera
country: New Zealand
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Tarnow
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.