Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
Launched by ASTRAZENECA · Feb 15, 2023
Trial Information
Current as of May 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called PROSPERO, is researching the long-term effects and safety of a medication called Tozorakimab for adults with Chronic Obstructive Pulmonary Disease (COPD) who have experienced worsening symptoms, known as exacerbations. If you have recently completed another study (called OBERON or TITANIA) and are interested, you may be eligible to join this new phase of research. To qualify, you should not have stopped treatment early in the previous studies and must be able to provide consent to participate. Women who can become pregnant will need to have a negative pregnancy test and agree to use contraceptive methods during the trial.
If you join the trial, you will be randomly assigned to receive either Tozorakimab or a placebo (a treatment that looks like the real medication but has no active ingredients) without knowing which one you are receiving. This helps researchers understand how effective and safe Tozorakimab is compared to no treatment at all. It's important to note that there are some health conditions and medications that might prevent you from participating, so the study team will check if you meet all the requirements. If you take part, you'll help contribute to important research that could benefit others with COPD in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
- • 2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
- • 3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
- • 4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
- • 5. Capable of giving signed informed consent.
- Exclusion Criteria:
- • 1. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
- • 2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- • 3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
- 4. Known history of:
- • 1. Severe allergic reaction to any monoclonal and polyclonal antibody.
- • 2. Allergy or reaction to any component of the IP formulation.
- • 5. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
- • 6. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
- • 7. Participants who are not able to comply with the study requirements, procedures, and restrictions.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Tampa, Florida, United States
Gent, , Belgium
Madrid, , Spain
Malaga, , Spain
Normal, Illinois, United States
Zaragoza, , Spain
Leuven, , Belgium
Napoli, , Italy
Liege, , Belgium
Sassari, , Italy
Iowa City, Iowa, United States
Helsinki, , Finland
Tampere, , Finland
Turku, , Finland
Bordeaux, , France
Athens, , Greece
Bari, , Italy
Málaga, , Spain
Huntsville, Alabama, United States
Rehovot, , Israel
Kansas City, Kansas, United States
Buffalo, New York, United States
Pittsburgh, Pennsylvania, United States
Montreal, Quebec, Canada
Debrecen, , Hungary
Bydgoszcz, , Poland
North Dartmouth, Massachusetts, United States
Saint Louis, Missouri, United States
Durham, North Carolina, United States
Gastonia, North Carolina, United States
Philadelphia, Pennsylvania, United States
Sayre, Pennsylvania, United States
Pleven, , Bulgaria
Sofia, , Bulgaria
Hvidovre, , Denmark
Roskilde, , Denmark
Marburg, , Germany
Groningen, , Netherlands
Harderwijk, , Netherlands
Heerlen, , Netherlands
Bradford, , United Kingdom
Ormond Beach, Florida, United States
Toledo, Ohio, United States
Mckinney, Texas, United States
Ajax, Ontario, Canada
Boynton Beach, Florida, United States
Lisboa, , Portugal
Chihuahua, , Mexico
Bamberg, , Germany
Ioannina, , Greece
Thessaloniki, , Greece
Bergen, , Norway
Lørenskog, , Norway
Tønsberg, , Norway
Melbourne, , Australia
Northwood, , United Kingdom
Baltimore, Maryland, United States
Roma, , Italy
Plantation, Florida, United States
Fargo, North Dakota, United States
Dijon, , France
Tel Aviv, , Israel
Manila, , Philippines
Taichung, , Taiwan
Großhansdorf, , Germany
Valencia, , Spain
Winter Park, Florida, United States
Brno, , Czechia
Franklin, Tennessee, United States
Tomball, Texas, United States
Amarillo, Texas, United States
Milano, , Italy
Ruse, , Bulgaria
Jihlava, , Czechia
New Delhi, , India
Ashkelon, , Israel
Morelia, , Mexico
Budapest, , Hungary
Fort Worth, Texas, United States
Webster, Texas, United States
Chongqing, , China
München, , Germany
Cebu City, , Philippines
Taichung, , Taiwan
Sofia, , Bulgaria
Wroclaw, , Poland
Bucharest, , Romania
Cluj Napoca, , Romania
Brest Cedex, , France
Rock Hill, South Carolina, United States
Greenwood, Indiana, United States
Grand Rapids, Michigan, United States
Missoula, Montana, United States
Jindrichuv Hradec, , Czechia
Evergreen Park, Illinois, United States
Kanazawa Shi, , Japan
Newport Beach, California, United States
Nagpur, , India
Sakai Shi, , Japan
Seoul, , Korea, Republic Of
Iloilo City, , Philippines
Taipei, , Taiwan
Bangkok, , Thailand
Vejle, , Denmark
Turku, , Finland
Sliven, , Bulgaria
Yinchuan, , China
Jerusalem, , Israel
Kaohsiung, , Taiwan
Zutphen, , Netherlands
Bruxelles, , Belgium
Kingwood, Texas, United States
Nantes, , France
Changchun, , China
Wuhan, , China
Veracruz, , Mexico
Pozuelo De Alarcon, , Spain
Monterrey, , Mexico
Lima, , Peru
Bakersfield, California, United States
Northridge, California, United States
Berlin, , Germany
Dijon Cedex, , France
Montpellier Cedex 5, , France
Limoges, , France
Pensacola, Florida, United States
Mar Del Plata, , Argentina
Wollongong, , Australia
Dupnitsa, , Bulgaria
Kozloduy, , Bulgaria
Quebec, , Canada
Quebec, , Canada
Nanchang, , China
Köln, , Germany
Gyöngyös, , Hungary
Del. Cuauhtemoc, , Mexico
Nakhon Ratchasima, , Thailand
Hanoi, , Vietnam
Taiyuan, , China
Wuxi, , China
La Tronche, , France
Mosonmagyaróvár, , Hungary
Itabashi Ku, , Japan
Shinjuku Ku, , Japan
Brasov, , Romania
Malmö, , Sweden
Ho Chi Minh, , Vietnam
Edelény, , Hungary
Lund, , Sweden
Tulsa, Oklahoma, United States
Córdoba, , Argentina
Olomouc, , Czechia
Bodø, , Norway
Santander, , Spain
Nedlands, , Australia
Zwolle, , Netherlands
Eindhoven, , Netherlands
Kunming, , China
Shenzhen, , China
Xiamen, , China
Yangzhou, , China
Daegu, , Korea, Republic Of
Taoyuan, , Taiwan
Bowling Green, Kentucky, United States
Woodville South, , Australia
Beer Sheva, , Israel
Vila Nova De Gaia, , Portugal
Lincoln, California, United States
Zachary, Louisiana, United States
Farmington Hills, Michigan, United States
Edmonton, Alberta, Canada
Sheffield, Alabama, United States
Barranquilla, , Colombia
København Nv, , Denmark
Rzeszów, , Poland
Hsinchu, , Taiwan
Hat Yai, , Thailand
Mérida, , Mexico
Matosinhos, , Portugal
Százhalombatta, , Hungary
Petrich, , Bulgaria
Vratsa, , Bulgaria
Talca, , Chile
Lyon Cedex 04, , France
Wrocław, , Poland
Nagoya Shi, , Japan
Tempe, Arizona, United States
Southport, , Australia
Hohhot, , China
Tianjin, , China
Patras, , Greece
Taipei City, , Taiwan
Sherwood Park, Alberta, Canada
Tradate, , Italy
Fukuoka Shi, , Japan
Iwata Shi, , Japan
Joyo Shi, , Japan
Kokubunji Shi, , Japan
Matsusaka Shi, , Japan
Mizunami Shi, , Japan
Constanta, , Romania
Wollongong, , Australia
Haikou, , China
Incheon, , Korea, Republic Of
White Marsh, Maryland, United States
Caba, , Argentina
Florencio Varela, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
Curico, , Chile
Næstved, , Denmark
Białystok, , Poland
Katowice, , Poland
Ostrowiec świętokrzyski, , Poland
Khon Kaen, , Thailand
Muang,, , Thailand
Mersin, , Turkey
München Pasing, , Germany
Campbelltown, , Australia
Salerno, , Italy
Guadalajara, , Mexico
Poznań, , Poland
Porto Alegre, , Brazil
Chuo Ku, , Japan
Toshima Ku, , Japan
Kfar Saba, , Israel
Alexandroupolis, , Greece
Beijing, , China
Hefei, , China
Yokohama Shi, , Japan
Okayama, , Japan
Chongqing, , China
Hangzhou, , China
Mérida, , Spain
Lima, , Peru
ålborg, , Denmark
Iizuka Shi, , Japan
Kuopio, , Finland
Santiago, , Chile
Williamsburg, Virginia, United States
San Miguel De Tucumán, , Argentina
Baotou, , China
Linhai, , China
Nanjing, , China
Shijiazhuang, , China
Darmstadt, , Germany
Halle, , Germany
Peine, , Germany
Corby, , United Kingdom
Shipley, , United Kingdom
Guangzhou, , China
Hamamatsu Shi, , Japan
Shizuoka Shi, , Japan
Macquarie University, , Australia
Ningbo, , China
Sao Bernardo Do Campo, , Brazil
Dubois, Pennsylvania, United States
Krakow, , Poland
Naestved, , Denmark
Xuzhou, , China
Istanbul, , Turkey
Toulouse, , France
Xuzhou, , China
Belagavi, , India
Kawachinagano Shi, , Japan
Sao Paulo, , Brazil
Namur, , Belgium
Changsha, , China
Zunyi, , China
Grenoble, , France
Chengdu, , China
Cudahy, Wisconsin, United States
Spearwood, , Australia
Blumenau, , Brazil
Fujieda Shi, , Japan
Yokohama Shi, , Japan
Dehradun, , India
Yunlin, , Taiwan
Timisoara, , Romania
Osaka Shi, , Japan
San Fernando, , Argentina
Harderwijk, , Netherlands
Verona, , Italy
Oslo, , Norway
Thane, , India
Shanghai, , China
Mexico, , Mexico
Ibague, , Colombia
Zipaquira, , Colombia
Encs, , Hungary
Toyonaka Shi, , Japan
Göteborg, , Sweden
Lublin, , Poland
Buenos Aires, , Argentina
Corby, , United Kingdom
High Wycombe, , United Kingdom
Chengdu, , China
Muang, , Thailand
Coimbatore, , India
Jaipur, , India
Obihiro, , Japan
Piura, , Peru
Baguio, , Philippines
Bucharest, , Romania
Bang Kra So, , Thailand
Rionegro, , Colombia
Exohi Thessaloniki, , Greece
Enfield, , United Kingdom
Galdakao, , Spain
Preston, , United Kingdom
Ecatepec De Morelos, , Mexico
Ankara, , Turkey
Broumov, , Czechia
Oaxaca, , Mexico
Changde, , China
Suzhou, , China
Jeonju, , Korea, Republic Of
Frankstown, , Australia
Botucatu, , Brazil
Brasilia, , Brazil
Curitiba, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Zhanjiang, , China
Vercelli, , Italy
Ostróda, , Poland
Sosnowiec, , Poland
Houston, Texas, United States
Colchester, Vermont, United States
Lovech, , Bulgaria
Guelph, Ontario, Canada
Winchester, Ontario, Canada
Liberec 1, , Czechia
Hämeenlinna, , Finland
Nashik, , India
Benito Juarez, , Mexico
Stockholm, , Sweden
Copenhagen, , Denmark
Troyan, , Bulgaria
Asahikawa Shi, , Japan
Santiago, , Chile
Kobe Shi, , Japan
Cape Coral, Florida, United States
Mueang, , Thailand
Rokycany, , Czechia
Godoy Cruz, , Peru
Carrara, , Italy
Hiroshima Shi, , Japan
Baton Rouge, Louisiana, United States
Beijing, , China
Statte, , Italy
Telese Terme, , Italy
Guangzhou, , China
Marseille Cedex 15, , France
Shenyang, , China
Rionegro, , Colombia
Guimaraes, , Portugal
Merida, , Spain
Vila Franca De Xira, , Portugal
Ahrensburg, , Germany
Tianjin, , China
Hohhot, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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