Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
Launched by ASTRAZENECA · Sep 11, 2023
Trial Information
Current as of June 20, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called tozorakimab to see how well it works and how safe it is for adults with Chronic Obstructive Pulmonary Disease (COPD) who have had multiple flare-ups in the past year. COPD is a long-term lung condition that makes it hard to breathe, and flare-ups can worsen symptoms and lead to serious health issues. To qualify for the trial, participants must be at least 40 years old, have a confirmed diagnosis of COPD for at least a year, and have experienced either two moderate or one severe flare-up within the last 12 months. They should also be on a stable treatment plan with specific inhaled medications for at least three months before joining the study.
Participants in the trial will receive tozorakimab through a simple injection under the skin and will be carefully monitored throughout the study. The trial is currently looking for volunteers, and it's important for potential participants to be in relatively good health and not have other significant health issues that could interfere with the study. This research is crucial because it may help improve treatment options for those living with COPD and reduce the frequency of flare-ups, ultimately enhancing their quality of life.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Participant must be ≥ 40 years of age and capable of giving signed informed consent.
- • 2. Documented diagnosis of COPD for at least one year prior to enrolment.
- • 3. Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value
- • 4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- • 5. Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
- • 6. Smoking history of ≥ 10 pack-years.
- • 7. CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2
- Exclusion Criteria:
- • 1. Clinically important pulmonary disease other than COPD.
- • 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection.
- • 3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18
- • 4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
- • 5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
- • 6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
- • 7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
- • 8. Significant COVID-19 illness within the 6 months prior to enrolment.
- • 9. Unstable cardiovascular disorder.
- • 10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
- • 11. History of active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.
- • 12. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
- • 13. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
- • 14. Evidence of active liver disease, including jaundice during screening.
- • 15. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
- • 16. Participants who have evidence of active TB.
- • 17. History of partial or total lung resection.
- • 18. Scheduled major surgical procedure during the course of the study.
- • 19. Participants that have previously received tozorakimab.
- • 20. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
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
Houston, Texas, United States
Izmir, , Turkey
Wooster, Ohio, United States
Sofia, , Bulgaria
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Edegem, , Belgium
Gent, , Belgium
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Madrid, , Spain
Malaga, , Spain
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Papillion, Nebraska, United States
El Paso, Texas, United States
Zaragoza, , Spain
Henderson, Nevada, United States
Leuven, , Belgium
Roeselare, , Belgium
Hannover, , Germany
Napoli, , Italy
Liege, , Belgium
Sofia, , Bulgaria
Barcelona, , Spain
Montpellier, , France
Budapest, , Hungary
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Málaga, , Spain
Cottingham, , United Kingdom
Liverpool, , United Kingdom
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Orange, California, United States
Debrecen, , Hungary
Bydgoszcz, , Poland
Birmingham, Alabama, United States
North Dartmouth, Massachusetts, United States
Winston Salem, North Carolina, United States
Chattanooga, Tennessee, United States
Jackson, Tennessee, United States
Dallas, Texas, United States
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Hvidovre, , Denmark
Roskilde, , Denmark
Marburg, , Germany
Szolnok, , Hungary
Pavia, , Italy
Arnhem, , Netherlands
Groningen, , Netherlands
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Milwaukee, Wisconsin, United States
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Marburg, , Germany
Nürnberg, , Germany
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Roma, , Italy
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Greenville, North Carolina, United States
Pécs, , Hungary
Großhansdorf, , Germany
San Antonio, Texas, United States
Saskatoon, Saskatchewan, Canada
Barcelona, , Spain
Buffalo, New York, United States
Huntersville, North Carolina, United States
Naples, Florida, United States
Ruse, , Bulgaria
Leipzig, , Germany
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Burlington, Ontario, Canada
San Francisco, California, United States
Tucson, Arizona, United States
New Orleans, Louisiana, United States
Beijing, , China
Beijing, , China
Chongqing, , China
Halle (Saale), , Germany
Moers, , Germany
Sofia, , Bulgaria
Frankfurt/Main, , Germany
Brest Cedex, , France
Marseille, , France
Badalona(barcelona), , Spain
Pisa, , Italy
Sao Paulo, , Brazil
Fort Wayne, Indiana, United States
Grants Pass, Oregon, United States
Cona, , Italy
Modena, , Italy
Newport Beach, California, United States
Champaign, Illinois, United States
Las Vegas, Nevada, United States
Nagpur, , India
Vejle, , Denmark
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Durango, , Mexico
Portsmouth, , United Kingdom
Roy, Utah, United States
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Caba, , Argentina
San Miguel De Tucuman, , Argentina
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Nanning, , China
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Essen, , Germany
Pisa, , Italy
Alor Setar, , Malaysia
Kuala Lumpur, , Malaysia
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Columbus, Georgia, United States
Chongqing, , China
Mechelen, , Belgium
Aix En Provence, , France
Reims, , France
Augsburg, , Germany
Zutphen, , Netherlands
Milwaukee, Wisconsin, United States
Dayton, Ohio, United States
Changchun, , China
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Wuhan, , China
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Houston, Texas, United States
Toms River, New Jersey, United States
München, , Germany
Leipzig, , Germany
Mar Del Plata, , Argentina
Dupnitsa, , Bulgaria
Kozloduy, , Bulgaria
Yambol, , Bulgaria
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Nanchang, , China
Shijiazhuang, , China
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Groningen, , Netherlands
Chrzanów, , Poland
Muang, , Thailand
Nakhon Ratchasima, , Thailand
Vinnytsia, , Ukraine
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Sao Bernardo Do Campo, , Brazil
La Tronche, , France
Mosonmagyaróvár, , Hungary
Itabashi Ku, , Japan
Kyoto Shi, , Japan
Shinjuku Ku, , Japan
Ho Chi Minh, , Vietnam
Edelény, , Hungary
Den Bosch, , Netherlands
Wakefield, , United Kingdom
Córdoba, , Argentina
Toronto, Ontario, Canada
Hannover, , Germany
Kyiv, , Ukraine
London, , United Kingdom
Rutland, Vermont, United States
Santander, , Spain
Habikino Shi, , Japan
Kobe Shi, , Japan
Nanjing, , China
Shenyang, , China
Shenzhen, , China
Ankara, , Turkey
Daegu, , Korea, Republic Of
Bowling Green, Kentucky, United States
İstanbul, , Turkey
Boulder, Colorado, United States
Chikushino Shi, , Japan
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Tucson, Arizona, United States
Westminster, California, United States
Union, South Carolina, United States
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
St Charles Borromee, Quebec, Canada
Sheffield, Alabama, United States
Bountiful, Utah, United States
Jinan, , China
Pingxiang, , China
København Nv, , Denmark
Pécs, , Hungary
Chuo Ku, , Japan
Osaka Shi, , Japan
Urasoe Shi, , Japan
Wonju Si, , Korea, Republic Of
Culiacan, , Mexico
Rzeszów, , Poland
Hat Yai, , Thailand
Hochiminh, , Vietnam
Incheon, , Korea, Republic Of
Nankoku Shi, , Japan
Winfield, Illinois, United States
Dublin, , Ireland
Gödöllő, , Hungary
Százhalombatta, , Hungary
Toshima Ku, , Japan
Evansville, Indiana, United States
Lyon Cedex 04, , France
Berlin, , Germany
Kraków, , Poland
Phoenix, Arizona, United States
Lanzhou, , China
Chuo Ku, , Japan
Kitakyushu Shi, , Japan
Sapporo Shi, , Japan
Kyiv, , Ukraine
Frankfurt, , Germany
Hajdúnánás, , Hungary
Kasuga Shi, , Japan
Kasugai Shi, , Japan
Matsusaka Shi, , Japan
Mizunami Shi, , Japan
Sakaide Shi, , Japan
Sapporo Shi, , Japan
Toon Shi, , Japan
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Yanagawa Shi, , Japan
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Quillota, , Chile
Shanghai, , China
Lutsk, , Ukraine
Caba, , Argentina
Florencio Varela, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
Curico, , Chile
Næstved, , Denmark
Białystok, , Poland
Katowice, , Poland
Ostrowiec świętokrzyski, , Poland
Sosnowiec, , Poland
Mersin, , Turkey
Aurora, Colorado, United States
München Pasing, , Germany
Ha Noi, , Vietnam
Vijayawada, , India
Guadalajara, , Mexico
Aomori Shi, , Japan
Mexico City, , Mexico
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Poznań, , Poland
Aarhus, , Denmark
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Anyang Si, , Korea, Republic Of
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Kenosha, Wisconsin, United States
Kuantan, , Malaysia
Heraklion, , Greece
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Yokohama Shi, , Japan
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Mérida, , Spain
Belo Horizonte, , Brazil
Lima, , Peru
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Adana, , Turkey
Santiago, , Chile
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Halle, , Germany
Peine, , Germany
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Ningbo, , China
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Uzhhorod, , Ukraine
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Toride Shi, , Japan
Lublin, , Poland
Xuzhou, , China
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Panagyurishte, , Bulgaria
Białystok, , Poland
Püspökladány, , Hungary
Namur, , Belgium
Changsha, , China
Qingdao, , China
Fortaleza, , Brazil
Seremban, , Malaysia
Cork, , Ireland
Blumenau, , Brazil
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Omuta Shi, , Japan
Ube, , Japan
Buenos Aires, , Argentina
Nantong, , China
Dehradun, , India
Khlong Luang, , Thailand
Cortland, New York, United States
Hyderabad, , India
Jaipur, , India
Toronto, Ontario, Canada
Utsunomiya Shi, , Japan
Kraków, , Poland
Adana, , Turkey
San Fernando, , Argentina
Viña Del Mar, , Chile
Nan Chong, , China
Poznań, , Poland
Sapporo Shi, , Japan
Colmar, , France
Libourne Cedex, , France
Thane, , India
Calgary, Alberta, Canada
Shanghai, , China
Osaka Shi, , Japan
Encs, , Hungary
Toyonaka Shi, , Japan
Sao Jose Do Rio Preto, , Brazil
Buenos Aires, , Argentina
Taizhou, , China
Chengdu, , China
Morioka Shi, , Japan
Muang, , Thailand
Minneapolis, Minnesota, United States
Edmonton, Alberta, Canada
Atlanta, Georgia, United States
Chesterfield, Missouri, United States
Hannibal, Missouri, United States
Coimbatore, , India
Piura, , Peru
Exohi Thessaloniki, , Greece
Bydgoszcz, , Poland
Urayasu Shi, , Japan
Galway, , Ireland
Jieyang, , China
Ankara, , Turkey
Oaxaca, , Mexico
Ajmer, , India
Jeonju, , Korea, Republic Of
Ostróda, , Poland
Winchester, Ontario, Canada
Benito Juarez, , Mexico
Mendoza, , Argentina
Delhi, , India
Shenyang, , China
Newcastle Upon Tyne, , United Kingdom
Dublin, , Ireland
Santiago, , Chile
Kajang, , Malaysia
Sarawak Miri, , Malaysia
Cape Coral, Florida, United States
Mueang, , Thailand
Villefranche Sur Saone, , France
Epagny Metz Tessy, , France
Calicut, , India
Kota Bahru, , Malaysia
Caba, , Argentina
Izmir, , Turkey
Kolkata, , India
Mar Del Plata, , Argentina
Decatur, Alabama, United States
Campina Grande Do Sul, , Brazil
Valinhos, , Brazil
Essen, , Germany
Solingen, , Germany
Budapest, , Hungary
Linhai, , China
Istanbul, , Turkey
Liaocheng, , China
Denver, Colorado, United States
Ocala, Florida, United States
Canton, Michigan, United States
Bronx, New York, United States
Elizabethton, Tennessee, United States
Hohhot, , China
Xi'an, , China
Padua, , Italy
Macclesfield, , United Kingdom
Zigong, , China
Jaipur, , India
Hyderabad, , India
Phoenix, Arizona, United States
Guangzhou, , China
Huizhou, , China
Hakodate Shi, , Japan
Mino Shi, , Japan
Sendai Shi, , Japan
Monterrey, , Mexico
Queretaro, , Mexico
Tijuna, , Mexico
Kielce, , Poland
Płock, , Poland
Andover, Kansas, United States
Towson, Maryland, United States
Veliko Tanovo, , Bulgaria
Budapest, , Hungary
Dwarka, , India
Visakhapatnam, , India
Minokamo Shi, , Japan
Yokohama, , Japan
Kota Bharu, , Malaysia
Yuma, Arizona, United States
Charlotte, North Carolina, United States
Sagamihara Shi, , Japan
Kiyose Shi, , Japan
Ankara, , Turkey
Lithonia, Georgia, United States
Moneymore, , Ireland
Kumamoto Shi, , Japan
Lublin, , Poland
Chernivtsі, , Ukraine
Ivano Frankivsk, , Ukraine
Levis, Quebec, Canada
Lima, Ohio, United States
Minokamo Shi, , Japan
Quimper, , France
Lima, Ohio, United States
Zhytomyr, , Ukraine
Levis, Quebec, Canada
La Plata, , Argentina
Dallas, Texas, United States
Hefei, , China
Tarasove Village, , Ukraine
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported