A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
NCT ID: NCT01199289
Last Updated: 2021-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
315 participants
INTERVENTIONAL
2010-10-04
2011-12-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Placebo
SC injection.
AMG 827 140 mg
Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
AMG 827
SC injection.
AMG 827 210 mg
Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
AMG 827
SC injection.
AMG 827 280 mg
Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
AMG 827
SC injection.
Interventions
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AMG 827
SC injection.
Placebo
SC injection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Encinitas, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
Stockton, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Baltimore, Maryland, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Bozeman, Montana, United States
Research Site
Bellevue, Nebraska, United States
Research Site
Skillman, New Jersey, United States
Research Site
Rockville Centre, New York, United States
Research Site
High Point, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Lake Oswego, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Madison, Wisconsin, United States
Research Site
Feldbach, , Austria
Research Site
Hallein, , Austria
Research Site
Vienna, , Austria
Research Site
Brussels, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Helsinki, , Finland
Research Site
Jyväskylä, , Finland
Research Site
Turku, , Finland
Research Site
Edelény, , Hungary
Research Site
Mátraháza, , Hungary
Research Site
Tatabánya, , Hungary
Research Site
Törökbálint, , Hungary
Research Site
Zalaegerszeg - Pozva, , Hungary
Research Site
Rotterdam, , Netherlands
Research Site
Bialystok, , Poland
Research Site
Chodzież, , Poland
Research Site
Gdansk, , Poland
Research Site
Wroclaw, , Poland
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Bucheon-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090203
Identifier Type: -
Identifier Source: org_study_id