Clinical trial NCT01199289: A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Amgen
chronic inflammatory disease
wheezing
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.


Eligibility criteria: Inclusion Criteria:

* Men or women 18 to 65 years of age
* Percent of predicted FEV1 ≥ 50% and ≤ 80%
* At least 12% reversibility over pre-bronchodilator FEV1
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
* Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion Criteria:

* Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
* History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
* Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Primary outcomes:
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline and Week 12
measure: Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Daily Asthma Symptom Score to Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
timeFrame: Baseline and Week 12
measure: Proportion of Asthma Symptom-free Days
timeFrame: Up to Week 12
measure: Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
timeFrame: Week 8 (days 60 and 64), and pre-dose on Week 10
measure: Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
timeFrame: Week 8 (days 60 and 64), and pre-dose on Week 10
measure: Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
timeFrame: Week 8 (days 60 and 64), and pre-dose on Week 10
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Diego
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: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Bozeman
country: United States
facility: Research Site
state: Montana
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Skillman
country: United States
facility: Research Site
state: New Jersey
city: Rockville Centre
country: United States
facility: Research Site
state: New York
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Feldbach
country: Austria
facility: Research Site
city: Hallein
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Helsinki
country: Finland
facility: Research Site
city: Jyväskylä
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Edeleny
country: Hungary
facility: Research Site
city: Matrahaza
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Zalaegerszeg - Pozva
country: Hungary
facility: Research Site
city: Bucheon-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Chodziez
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Busse WW, Holgate S, Kerwin E, Chon Y, Feng J, Lin J, Lin SL. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1294-302. doi: 10.1164/rccm.201212-2318OC.