A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
Launched by ASTRAZENECA · Mar 12, 2025
Trial Information
Current as of May 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a medication called Tezepelumab to see how well it works and how safe it is for adults with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe. The study is currently looking for participants aged between 40 and 80 who have been diagnosed with COPD for at least a year. To be eligible, participants should have had two or more moderate flare-ups of their COPD in the past year or one severe flare-up that needed stronger medications. They should also be using specific types of inhaled treatments for their COPD.
If you join this study, you will be randomly assigned to receive either Tezepelumab or a placebo (a treatment that looks like the real medication but doesn't contain any active ingredients). The trial is designed to be fair and unbiased, meaning neither you nor the researchers will know which treatment you are receiving. Throughout the study, your health will be closely monitored to ensure your safety and to collect important information about how the medication works. Participating in this trial could contribute to important research that may help improve treatments for COPD in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. ≥40 to ≤80 years old
- • 2. COPD diagnosis ≥1 year,
- • 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
- • 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1
- • 5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids
- • 6. EOS ≥ 150 cells/μL during screening
- • 7. CAT ≥15 at screening
- • 8. Former or current smokers ≥10 pack-years
- Exclusion Criteria:
- • 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
- • 2. Asthma, incl. pediatric, or ACOS
- • 3. Any unstable disorder that can impact participants safety or study outcomes
- • 4. Tuberculosis requiring treatment within 12 months prior V2
- • 5. Malignancies current or past
- Concomitant therapies:
- • Macrolides (less than 6 months)
- • Systemic immuno-suppressive, -modulating medications
- • 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
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
Hong Kong, , Hong Kong
Indianapolis, Indiana, United States
Jacksonville, Florida, United States
Stara Zagora, , Bulgaria
Gent, , Belgium
Clearwater, Florida, United States
El Paso, Texas, United States
Leuven, , Belgium
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Rehovot, , Israel
Kansas City, Kansas, United States
Debrecen, , Hungary
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Spartanburg, South Carolina, United States
Genk, , Belgium
Plovdiv, , Bulgaria
Hvidovre, , Denmark
Saint Herblain, , France
Haifa, , Israel
Eindhoven, , Netherlands
Rotterdam, , Netherlands
Savannah, Georgia, United States
Mckinney, Texas, United States
Boynton Beach, Florida, United States
Gaffney, South Carolina, United States
Athens, , Greece
Ioannina, , Greece
Maastricht, , Netherlands
Baltimore, Maryland, United States
Ramat Gan, , Israel
Tel Aviv, , Israel
Lund, , Sweden
Miami Lakes, Florida, United States
Törökbálint, , Hungary
Winter Park, Florida, United States
Pessac, , France
Ashkelon, , Israel
Durban, , South Africa
Budapest, , Hungary
Oklahoma City, Oklahoma, United States
Miami, Florida, United States
Sofia, , Bulgaria
Ruse, , Bulgaria
Heraklion, , Greece
Tauranga, , New Zealand
Grants Pass, Oregon, United States
Kitakyushu Shi, , Japan
Shinjuku Ku, , Japan
Redding, California, United States
Bangkok, , Thailand
Vejle, , Denmark
San Diego, California, United States
Margate, Florida, United States
Garran, , Australia
Cape Town, , South Africa
Somerset West, , South Africa
Brest Cedex 2, , France
Aalborg, , Denmark
Rapid City, South Dakota, United States
Boerne, Texas, United States
Mechelen, , Belgium
Zutphen, , Netherlands
Houston, Texas, United States
Leesburg, Florida, United States
Lima, , Peru
Thessaloniki, , Greece
Odense C, , Denmark
Bucharest, , Romania
Montpellier Cedex 5, , France
Mar Del Plata, , Argentina
Wollongong, , Australia
Dupnitsa, , Bulgaria
Yambol, , Bulgaria
Kasuga Shi, , Japan
Yokohama Shi, , Japan
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Mosonmagyaróvár, , Hungary
Ho Chi Minh, , Vietnam
Edelény, , Hungary
Charlotte, North Carolina, United States
Tulsa, Oklahoma, United States
Kocaeli, , Turkey
Nedlands, , Australia
Kobe Shi, , Japan
Paris, , France
Bowling Green, Kentucky, United States
Woodville South, , Australia
Kfar Saba, , Israel
Palmetto Bay, Florida, United States
Union, South Carolina, United States
Knoxville, Tennessee, United States
Everett, Washington, United States
Armenia, , Colombia
Fukui Shi, , Japan
Takamatsu Shi, , Japan
örebro, , Sweden
Hat Yai, , Thailand
Kayseri, , Turkey
Gödöllő, , Hungary
Kiyose Shi, , Japan
Toshima Ku, , Japan
Evansville, Indiana, United States
Buenos Aires, , Argentina
Lyon Cedex 04, , France
Tempe, Arizona, United States
Hatvan, , Hungary
Meguro Ku, , Japan
Frankston, , Australia
Fukuoka Shi, , Japan
Nagaoka Shi, , Japan
Hai Phong, , Vietnam
Florencio Varela, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
Vidin, , Bulgaria
Næstved, , Denmark
Marseille, , France
Hamilton West, , New Zealand
Istanbul, , Turkey
Hue, , Vietnam
Nagasaki Shi, , Japan
Barranquilla, , Colombia
Sendai Shi, , Japan
Nagoya Shi, , Japan
Lima, , Peru
Adana, , Turkey
Lewisville, Texas, United States
Williamsburg, Virginia, United States
Florida, , Argentina
Mersin, , Turkey
Paris Cedex 18, , France
Kure Shi, , Japan
Benoni, , South Africa
Manizales, , Colombia
Miyazaki Shi, , Japan
Okayama Shi, , Japan
Owensboro, Kentucky, United States
Namur, , Belgium
Akashi Shi, , Japan
Spearwood, , Australia
Ube, , Japan
Adairsville, Georgia, United States
Timisoara, , Romania
San Fernando, , Argentina
Ibague, , Colombia
Auckland, , New Zealand
Pleven, , Bulgaria
Muang, , Thailand
Minneapolis, Minnesota, United States
Hannibal, Missouri, United States
Tanabe Shi, , Japan
Piura, , Peru
Bang Kra So, , Thailand
Hatyai, , Thailand
Colchester, Vermont, United States
Lovech, , Bulgaria
Tygervalley, , South Africa
Jette, , Belgium
Mueang, , Thailand
Atlanta, Georgia, United States
Jerusalem, , Israel
Alberdi, , Argentina
Cali, , Colombia
Da Nang, , Vietnam
Ocala, Florida, United States
Cluj Napoca, , Romania
Potomac, Maryland, United States
Patra, , Greece
Fayetteville, North Carolina, United States
Minato Ku, , Japan
Veliko Tanovo, , Bulgaria
Hong Kong, , Hong Kong
New Britain, Connecticut, United States
Coffs Harbour, , Australia
Kiyose Shi, , Japan
Nyíregyháza Sóstóhegy, , Hungary
La Plata, , Argentina
Stockholm, , Sweden
Fort Eisenhower, Georgia, United States
Medellin, , Colombia
Medellín, , Colombia
Nerima Ku, , Japan
Ohta Ku, , Japan
Karlskrona, , Sweden
Rayong, , Thailand
Ishinomaki, , Japan
Komatsu Shi, , Japan
Shiogama City, , Japan
Takatsuiki Shi, , Japan
Oradea, , Romania
Ankara, , Turkey
Patients applied
Trial Officials
MeiLan Han, MD
Principal Investigator
University of Michigan Health, Pulmonary & Critical Care Medicine,
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported