A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
NCT ID: NCT06878261
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
990 participants
INTERVENTIONAL
2025-03-25
2029-06-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose 1 of Tezepelumab
Tezepelumab, SC, Q4W
Tezepelumab
Tezepelumab subcutaneous injection
Dose 2 of Tezepelumab
Tezepelumab, SC, Q4W
Tezepelumab
Tezepelumab subcutaneous injection
Matching Placebo
Matching placebo, SC, Q4W
Placebo
Placebo subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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, if triple therapy is considered not appropriate, ≥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. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
6. EOS ≥ 150 cells/μL during screening
7. CAT ≥15 at screening
8. Former or current smokers ≥10 pack-years
Exclusion Criteria
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
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MeiLan Han, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Health, Pulmonary & Critical Care Medicine,
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Cullman, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Inglewood, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palo Alto, California, United States
Research Site
Redding, California, United States
Research Site
San Diego, California, United States
Research Site
New Britain, Connecticut, United States
Research Site
Wilmington, Delaware, United States
Research Site
Bay Pines, Florida, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Fleming Island, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Leesburg, Florida, United States
Research Site
Margate, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Palmetto Bay, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Adairsville, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Cordele, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Fort Eisenhower, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Evansville, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Kansas City, Kansas, United States
Research Site
Bowling Green, Kentucky, United States
Research Site
Owensboro, Kentucky, United States
Research Site
Baltimore, Maryland, United States
Research Site
Potomac, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Hannibal, Missouri, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Fayetteville, North Carolina, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Grants Pass, Oregon, United States
Research Site
Anderson, South Carolina, United States
Research Site
Columbia, South Carolina, United States
Research Site
Gaffney, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Union, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Boerne, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Lewisville, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Mesquite, Texas, United States
Research Site
Colchester, Vermont, United States
Research Site
Williamsburg, Virginia, United States
Research Site
Everett, Washington, United States
Research Site
Alberdi, , Argentina
Research Site
Buenos Aires, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Florida, , Argentina
Research Site
La Plata, , Argentina
Research Site
La Plata, , Argentina
Research Site
Mar del Plata, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Quilmes, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Fernando, , Argentina
Research Site
San Juan Bautista, , Argentina
Research Site
Coffs Harbour, , Australia
Research Site
Frankston, , Australia
Research Site
Garran, , Australia
Research Site
Nedlands, , Australia
Research Site
New Lambton, , Australia
Research Site
Spearwood, , Australia
Research Site
Wollongong, , Australia
Research Site
Woodville South, , Australia
Research Site
Genk, , Belgium
Research Site
Ghent, , Belgium
Research Site
Jette, , Belgium
Research Site
Leuven, , Belgium
Research Site
Mechelen, , Belgium
Research Site
Namur, , Belgium
Research Site
Dupnitsa, , Bulgaria
Research Site
Haskovo, , Bulgaria
Research Site
Lovech, , Bulgaria
Research Site
Pleven, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Veliko Tanovo, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Vidin, , Bulgaria
Research Site
Yambol, , Bulgaria
Research Site
Armenia, , Colombia
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Cali, , Colombia
Research Site
Ibagué, , Colombia
Research Site
Manizales, , Colombia
Research Site
Medellín, , Colombia
Research Site
Medellín, , Colombia
Research Site
Aalborg, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Næstved, , Denmark
Research Site
Odense C, , Denmark
Research Site
Vejle, , Denmark
Research Site
Brest, , France
Research Site
Lyon, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Pessac, , France
Research Site
Saint-Herblain, , France
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Heraklion, , Greece
Research Site
Ioannina, , Greece
Research Site
Pátrai, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Hong Kong, , Hong Kong
Research Site
Hong Kong, , Hong Kong
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Edelény, , Hungary
Research Site
Gödöllő, , Hungary
Research Site
Hatvan, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Nyíregyháza-Sóstóhegy, , Hungary
Research Site
Törökbálint, , Hungary
Research Site
Ashkelon, , Israel
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Jerusalem, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Akashi-shi, , Japan
Research Site
Chikushino-shi, , Japan
Research Site
Chiyoda-ku, , Japan
Research Site
Fukui-shi, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukuoka, , Japan
Research Site
Gifu, , Japan
Research Site
Iruma-Gun, , Japan
Research Site
Ishinomaki, , Japan
Research Site
Kasuga-shi, , Japan
Research Site
Kitakyushu-shi, , Japan
Research Site
Kiyose-shi, , Japan
Research Site
Kiyose-shi, , Japan
Research Site
Kobe, , Japan
Research Site
Komatsu-shi, , Japan
Research Site
Kure-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Matsusaka-shi, , Japan
Research Site
Meguro-ku, , Japan
Research Site
Minatoku, , Japan
Research Site
Minatoku, , Japan
Research Site
Miyazaki, , Japan
Research Site
Mizunami-shi, , Japan
Research Site
Nagaoka-shi, , Japan
Research Site
Nagasaki, , Japan
Research Site
Nagoya, , Japan
Research Site
Nagoya, , Japan
Research Site
Nagoya, , Japan
Research Site
Nerima-ku, , Japan
Research Site
Ohta-ku, , Japan
Research Site
Okayama, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, , Japan
Research Site
Sapporo, , Japan
Research Site
Sendai, , Japan
Research Site
Sendai, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Shiogama, , Japan
Research Site
Takamatsu, , Japan
Research Site
Takatsuiki-shi, , Japan
Research Site
Tanabe-shi, , Japan
Research Site
Toshima-ku, , Japan
Research Site
Ube, , Japan
Research Site
Yokohama, , Japan
Research Site
Yokohama, , Japan
Research Site
Eindhoven, , Netherlands
Research Site
Maastricht, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Zutphen, , Netherlands
Research Site
Auckland, , New Zealand
Research Site
Auckland, , New Zealand
Research Site
Auckland, , New Zealand
Research Site
Hamilton West, , New Zealand
Research Site
Tauranga, , New Zealand
Research Site
Cusco, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Piura, , Peru
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Oradea, , Romania
Research Site
Timișoara, , Romania
Research Site
Timișoara, , Romania
Research Site
Benoni, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Durban, , South Africa
Research Site
eMkhomazi, , South Africa
Research Site
Kimberley, , South Africa
Research Site
Somerset West, , South Africa
Research Site
Tygervalley, , South Africa
Research Site
Gothenburg, , Sweden
Research Site
Karlskrona, , Sweden
Research Site
Lund, , Sweden
Research Site
Örebro, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Bang Kra So, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Muang, , Thailand
Research Site
Muang, , Thailand
Research Site
Mueang, , Thailand
Research Site
Rayong, , Thailand
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Kayseri, , Turkey (Türkiye)
Research Site
Kocaeli, , Turkey (Türkiye)
Research Site
Mersin, , Turkey (Türkiye)
Research Site
Da Nang, , Vietnam
Research Site
Haiphong, , Vietnam
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Hồ Chí Minh, , Vietnam
Research Site
Huế, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D5241C00007
Identifier Type: -
Identifier Source: org_study_id