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Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
Sponsor: AstraZeneca
Summary
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
Key Details
Gender
All
Age Range
40 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1713
Start Date
2023-03-06
Completion Date
2026-05-28
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Tozorakimab 1
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Tozorakimab 2
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Placebo
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
Locations (335)
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Sheffield, Alabama, United States
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Tempe, Arizona, United States
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Lincoln, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Boynton Beach, Florida, United States
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Cape Coral, Florida, United States
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Ormond Beach, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Evergreen Park, Illinois, United States
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Normal, Illinois, United States
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Greenwood, Indiana, United States
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Kansas City, Kansas, United States
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Bowling Green, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Zachary, Louisiana, United States
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Baltimore, Maryland, United States
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White Marsh, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Buffalo, New York, United States
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Durham, North Carolina, United States
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Gastonia, North Carolina, United States
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Fargo, North Dakota, United States
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Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
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DuBois, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Franklin, Tennessee, United States
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Amarillo, Texas, United States
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Boerne, Texas, United States
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Kingwood, Texas, United States
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McKinney, Texas, United States
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Tomball, Texas, United States
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Colchester, Vermont, United States
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Williamsburg, Virginia, United States
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Cudahy, Wisconsin, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Quilmes, Argentina
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San Fernando, Argentina
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San Juan Bautista, Argentina
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San Miguel de Tucumán, Argentina
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Campbelltown, Australia
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Frankstown, Australia
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Macquarie University, Australia
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Melbourne, Australia
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Nedlands, Australia
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Southport, Australia
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Spearwood, Australia
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Wollongong, Australia
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Woodville South, Australia
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Namur, Belgium
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Blumenau, Brazil
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Botucatu, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Dupnitsa, Bulgaria
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Lovech, Bulgaria
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Petrich, Bulgaria
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sliven, Bulgaria
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Sofia, Bulgaria
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Vratsa, Bulgaria
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Edmonton, Alberta, Canada
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Ajax, Ontario, Canada
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Winchester, Ontario, Canada
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Santiago, Chile
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Santiago, Chile
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Talca, Chile
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Baotou, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Haikou, China
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Hangzhou, China
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Hohhot, China
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Kunming, China
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Nanjing, China
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Ningbo, China
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Zhanjiang, China
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Zunyi, China
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Barranquilla, Colombia
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Ibagué, Colombia
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Rionegro, Colombia
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Zipaquirá, Colombia
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Brno, Czechia
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Jindřichův Hradec, Czechia
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Liberec, Czechia
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Olomouc, Czechia
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Rokycany, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Hvidovre, Denmark
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Næstved, Denmark
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Roskilde, Denmark
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Vejle, Denmark
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Hämeenlinna, Finland
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Kuopio, Finland
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Turku, Finland
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Lyon, France
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Nantes, France
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Berlin, Germany
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Halle, Germany
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Marburg, Germany
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Peine, Germany
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Alexandroupoli, Greece
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Exohi Thessaloniki, Greece
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Bari, Italy
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Milan, Italy
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Vercelli, Italy
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Kanazawa, Japan
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Osaka, Japan
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Osaka, Japan
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Shizuoka, Japan
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Toyonaka-shi, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Veracruz, Mexico
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Eindhoven, Netherlands
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Groningen, Netherlands
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Harderwijk, Netherlands
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Heerlen, Netherlands
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Zutphen, Netherlands
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Lørenskog, Norway
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Oslo, Norway
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Tønsberg, Norway
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Baguio City, Philippines
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Iloilo City, Philippines
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Bydgoszcz, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Ostrowiec Świętokrzyski, Poland
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Ostróda, Poland
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Poznan, Poland
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Rzeszów, Poland
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Sosnowiec, Poland
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Wroclaw, Poland
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Lisbon, Portugal
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Lisbon, Portugal
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Matosinhos Municipality, Portugal
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Vila Franca de Xira, Portugal
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Bucharest, Romania
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Timișoara, Romania
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Daegu, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Madrid, Spain
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Mérida, Spain
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Pozuelo de Alarcón, Spain
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Santander, Spain
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Valencia, Spain
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Zaragoza, Spain
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Gothenburg, Sweden
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Gothenburg, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Hsinchu, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Yunlin, Taiwan
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Bang Kra So, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Muang,, Thailand
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Muang, Thailand
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Mueang, Thailand
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Nakhon Ratchasima, Thailand
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Bradford, United Kingdom
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Corby, United Kingdom
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Corby, United Kingdom
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High Wycombe, United Kingdom
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Northwood, United Kingdom
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Preston, United Kingdom
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Shipley, United Kingdom
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Hanoi, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam