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Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
Sponsor: AstraZeneca
Summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.
Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (MIRANDA)
Key Details
Gender
All
Age Range
40 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1454
Start Date
2023-09-22
Completion Date
2026-05-22
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
Placebo
Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study.
Tozorakimab
Administered subcutaneously tozorakimab and placebo throughout the study.
Locations (368)
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Birmingham, Alabama, United States
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Decatur, Alabama, United States
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Sheffield, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Yuma, Arizona, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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San Francisco, California, United States
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Westminster, California, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Cape Coral, Florida, United States
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Lakeland, Florida, United States
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Lakeland, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Ormond Beach, Florida, United States
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Atlanta, Georgia, United States
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Lithonia, Georgia, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Andover, Kansas, United States
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Bowling Green, Kentucky, United States
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Lexington, Kentucky, United States
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Towson, Maryland, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Chesterfield, Missouri, United States
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Chesterfield, Missouri, United States
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Hannibal, Missouri, United States
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Papillion, Nebraska, United States
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Las Vegas, Nevada, United States
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Toms River, New Jersey, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Dayton, Ohio, United States
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Lima, Ohio, United States
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Grants Pass, Oregon, United States
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Gaffney, South Carolina, United States
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Union, South Carolina, United States
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Chattanooga, Tennessee, United States
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Elizabethton, Tennessee, United States
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Jackson, Tennessee, United States
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Pingxiang, China
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Shanghai, China
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Shenyang, China
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Shijiazhuang, China
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Xi'an, China
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Aalborg, Denmark
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Aarhus, Denmark
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Hvidovre, Denmark
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København NV, Denmark
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Næstved, Denmark
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Roskilde, Denmark
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Hamamatsu, Japan
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Kyoto, Japan
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Minoh, Japan
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Morioka, Japan
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Nagoya, Japan
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Nankoku-shi, Japan
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Sagamihara-shi, Japan
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Sapporo, Japan
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Sapporo, Japan
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Shizuoka, Japan
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Ube, Japan
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Yokohama, Japan
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Yokohama, Japan
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Zutphen, Netherlands
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Lima, Peru
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Piura, Peru
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Santa Beatriz, Peru
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Bydgoszcz, Poland
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Chrzanów, Poland
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Płock, Poland
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Rzeszów, Poland
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Daegu, South Korea
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Incheon, South Korea
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Muang, Thailand
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Mueang, Thailand
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Nakhon Ratchasima, Thailand
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Ivano-Frankivsk, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Tarasove Village, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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