Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
Launched by ASTRAZENECA · Dec 9, 2021
Trial Information
Current as of May 22, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called tozorakimab for adults with Chronic Obstructive Pulmonary Disease (COPD) who have experienced worsening symptoms recently. The main goal is to see how effective and safe tozorakimab is for people who have had at least two moderate flare-ups or one severe flare-up of their COPD in the past year. To be eligible for the study, participants need to be at least 40 years old, have been diagnosed with COPD for over a year, and have been on stable inhaled medication for at least three months.
If you or a family member are considering participating, you can expect to receive either one of two doses of tozorakimab or a placebo (a treatment that doesn't contain the active drug) given as an injection under the skin. The study will help researchers understand if this new treatment can improve symptoms and reduce the number of flare-ups in people with COPD. It’s important to note that those with certain other health issues or recent significant infections won't be eligible to join. Participants will be closely monitored throughout the trial to ensure their safety and gather important information about the treatment.
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 optimized inhaled dual or triple therapy at a stable dose 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.
- • 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 known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
- • 12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
- • 13. Evidence of active liver disease, including jaundice during screening.
- • 14. 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.
- • 15. Participants who have evidence of active TB.
- • 16. Participants that have previously received tozorakimab.
- • 17. 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.
- • 18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during 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
Rochester, Minnesota, United States
Durham, North Carolina, United States
Nashville, Tennessee, United States
Jacksonville, Florida, United States
Gent, , Belgium
Székesfehérvár, , Hungary
Madrid, , Spain
Malaga, , Spain
Tacoma, Washington, United States
Fort Worth, Texas, United States
Normal, Illinois, United States
Zaragoza, , Spain
Leuven, , Belgium
Evanston, Illinois, United States
Liege, , Belgium
Varna, , Bulgaria
Iowa City, Iowa, United States
Salt Lake City, Utah, United States
Raleigh, North Carolina, United States
Helsinki, , Finland
Tampere, , Finland
Turku, , Finland
Málaga, , Spain
Huntsville, Alabama, United States
Burlington, Vermont, United States
Albuquerque, New Mexico, United States
Pittsburgh, Pennsylvania, United States
Montreal, Quebec, Canada
Debrecen, , Hungary
Mobile, Alabama, United States
Meridian, Idaho, United States
Saint Louis, Missouri, United States
Gastonia, North Carolina, United States
Hershey, Pennsylvania, United States
Sayre, Pennsylvania, United States
Pleven, , Bulgaria
Sofia, , Bulgaria
Hvidovre, , Denmark
Roskilde, , Denmark
Alkmaar, , Netherlands
Groningen, , Netherlands
Harderwijk, , Netherlands
Heerlen, , Netherlands
Ormond Beach, Florida, United States
Brick, New Jersey, United States
Ajax, Ontario, Canada
Boynton Beach, Florida, United States
Chihuahua, , Mexico
Marshfield, Wisconsin, United States
Bergen, , Norway
Lørenskog, , Norway
Tønsberg, , Norway
Baltimore, Maryland, United States
Plantation, Florida, United States
Fargo, North Dakota, United States
Valencia, , Spain
Brno, , Czechia
Franklin, Tennessee, United States
Sacramento, California, United States
Buffalo, New York, United States
East Setauket, New York, United States
Ruse, , Bulgaria
Jihlava, , Czechia
New Delhi, , India
New Delhi, , India
Morelia, , Mexico
Guaynabo, , Puerto Rico
Budapest, , Hungary
Palm Springs, California, United States
Sofia, , Bulgaria
Baja, , Hungary
Missoula, Montana, United States
Jindrichuv Hradec, , Czechia
Evergreen Park, Illinois, United States
Charleston, West Virginia, United States
Kanazawa Shi, , Japan
Seoul, , Korea, Republic Of
Nagpur, , India
Kamogawa Shi, , Japan
Mitaka Shi, , Japan
Vejle, , Denmark
Yamagata Shi, , Japan
Albuquerque, New Mexico, United States
North Massapequa, New York, United States
San Miguel De Tucuman, , Argentina
Sliven, , Bulgaria
Sandanski, , Bulgaria
Rapid City, South Dakota, United States
örebro, , Sweden
Hamilton, Ontario, Canada
Zutphen, , Netherlands
Bruxelles, , Belgium
Kingwood, Texas, United States
Veracruz, , Mexico
Nishinomiya Shi, , Japan
Sakai Shi, , Japan
Pozuelo De Alarcon, , Spain
Monterrey, , Mexico
Montgomery, Alabama, United States
Bakersfield, California, United States
New York, New York, United States
Oslo, , Norway
New Hyde Park, New York, United States
New York, New York, United States
Mar Del Plata, , Argentina
Dupnitsa, , Bulgaria
Kozloduy, , Bulgaria
Terrebonne, Quebec, Canada
Quebec, , Canada
Gyöngyös, , Hungary
Hanoi, , Vietnam
Hawthorne, New York, United States
Mosonmagyaróvár, , Hungary
Itabashi Ku, , Japan
Shinjuku Ku, , Japan
Göteborg, , Sweden
Malmö, , Sweden
Ho Chi Minh, , Vietnam
Edelény, , Hungary
Lund, , Sweden
Charlotte, North Carolina, United States
Córdoba, , Argentina
Mlada Boleslav, , Czechia
Olomouc, , Czechia
Bodø, , Norway
Santander, , Spain
Zwolle, , Netherlands
Eindhoven, , Netherlands
Kawasaki Shi, , Japan
Daegu, , Korea, Republic Of
Lisboa, , Portugal
Vila Nova De Gaia, , Portugal
Chikushino Shi, , Japan
Zachary, Louisiana, United States
Houston, Texas, United States
Edmonton, Alberta, Canada
Kamloops, British Columbia, Canada
Kelowna, British Columbia, Canada
Ranelagh, , Argentina
København Nv, , Denmark
Koga Shi, , Japan
Takamatsu Shi, , Japan
Mérida, , Mexico
Chicago, Illinois, United States
Matosinhos, , Portugal
San Juan, , Puerto Rico
Százhalombatta, , Hungary
Kiyose Shi, , Japan
Petrich, , Bulgaria
Vratsa, , Bulgaria
Nagoya Shi, , Japan
Tempe, Arizona, United States
Sherwood Park, Alberta, Canada
Rokycany, , Czechia
Fukuoka Shi, , Japan
Himeji Shi, , Japan
Iwata Shi, , Japan
Joyo Shi, , Japan
Kokubunji Shi, , Japan
Matsusaka Shi, , Japan
Meguro Ku, , Japan
Mizunami Shi, , Japan
Nagaoka Shi, , Japan
Seto Shi, , Japan
Yanagawa Shi, , Japan
Okayama Shi, , Japan
Incheon, , Korea, Republic Of
Kissimmee, Florida, United States
Caba, , Argentina
Florencio Varela, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
Næstved, , Denmark
Mersin, , Turkey
Kolkatta, , India
Izmir, , Turkey
Guadalajara, , Mexico
Aarhus, , Denmark
Chuo Ku, , Japan
Toshima Ku, , Japan
Istanbul, , Turkey
Nagaoka Shi, , Japan
Nagoya Shi, , Japan
Yokohama Shi, , Japan
Okayama, , Japan
Mérida, , Spain
Jeonju Si, , Korea, Republic Of
ålborg, , Denmark
Iizuka Shi, , Japan
Izumi Shi, , Japan
Kuopio, , Finland
Bronx, New York, United States
Sherman, Texas, United States
Hamamatsu Shi, , Japan
Shizuoka Shi, , Japan
Tachikawa Shi, , Japan
Kagoshima Shi, , Japan
Dubois, Pennsylvania, United States
Belagavi, , India
Kitakyusyu Shi, , Japan
Wakayama Shi, , Japan
Kawachinagano Shi, , Japan
Phoenix, Arizona, United States
Haskovo, , Bulgaria
Mexico City, , Mexico
Namur, , Belgium
Aydin, , Turkey
Fujieda Shi, , Japan
Hamamatsu Shi, , Japan
Kanazawa Shi, , Japan
Kitakyusyu, , Japan
Yokohama Shi, , Japan
Dehradun, , India
Bunkyo Ku, , Japan
Osaka Shi, , Japan
San Fernando, , Argentina
Surat, , India
Thane, , India
Sapporo Shi, , Japan
Tucumán, , Argentina
Stouffville, Ontario, Canada
Encs, , Hungary
Koto Ku, , Japan
Toyonaka Shi, , Japan
Göteborg, , Sweden
Buenos Aires, , Argentina
Aydin, , Turkey
Aligarh, , India
Coimbatore, , India
Jaipur, , India
Mohali, , India
Miyazaki Shi, , Japan
Obihiro, , Japan
Galdakao, , Spain
Narita Shi, , Japan
Ankara, , Turkey
Broumov, , Czechia
Oaxaca, , Mexico
Brookhaven, Georgia, United States
Kansas City, Kansas, United States
Baton Rouge, Louisiana, United States
Houston, Texas, United States
Colchester, Vermont, United States
Lovech, , Bulgaria
Calgary, Alberta, Canada
Barrie, Ontario, Canada
Guelph, Ontario, Canada
Markham, Ontario, Canada
Winchester, Ontario, Canada
Liberec 1, , Czechia
Hämeenlinna, , Finland
Nashik, , India
Sakaide Shi, , Japan
Benito Juarez, , Mexico
Levanger, , Norway
Stockholm, , Sweden
Cleveland, Texas, United States
Troyan, , Bulgaria
Montreal, Pq, Canada
Asahikawa Shi, , Japan
Saku Shi, , Japan
Kobe Shi, , Japan
Kakogawa Shi, , Japan
Niigata Shi, , Japan
Hiroshima Shi, , Japan
Ahmedabad, , India
Guttenberg, New Jersey, United States
Hiroshima Shi, , Japan
Kofu Shi, , Japan
Sendai Shi, , Japan
ålesund, , Norway
Schenectady, New York, United States
Toyama Shi, , Japan
Hyderabad, , India
San Juan, , Puerto Rico
Guimaraes, , Portugal
Merida, , Spain
Massapequa, New York, United States
Vila Franca De Xira, , Portugal
Nyíregyháza Sóstóhegy, , Hungary
Aydin, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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