← Back to searchRecruitingRecruiting
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
NCT06878261 · AstraZeneca
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
About this study
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.
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, 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:
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
Study design
Enrollment target: 990 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-25
Estimated completion: 2029-06-05
Last updated: 2026-04-13
Interventions
Biological: TezepelumabOther: Placebo
Primary outcomes
- • Annualised rate of moderate or severe COPD exacerbations (Baseline up to 76 weeks)
Sponsor
AstraZeneca · industry
With: Amgen
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
InvestigatorMeiLan Han, MD · principal_investigator, University of Michigan Health, Pulmonary & Critical Care Medicine,
All locations (268)
Research SiteRecruiting
Cullman, Alabama, United States
Research SiteRecruiting
Phoenix, Arizona, United States
Research SiteRecruiting
Scottsdale, Arizona, United States
Research SiteWithdrawn
Inglewood, California, United States
Research SiteRecruiting
Los Angeles, California, United States
Research SiteRecruiting
Palo Alto, California, United States
Research SiteRecruiting
Redding, California, United States
Research SiteRecruiting
San Diego, California, United States
Research SiteRecruiting
New Britain, Connecticut, United States
Research SiteRecruiting
Wilmington, Delaware, United States
Research SiteRecruiting
Bay Pines, Florida, United States
Research SiteRecruiting
Boynton Beach, Florida, United States
Research SiteRecruiting
Clearwater, Florida, United States
Research SiteRecruiting
Fleming Island, Florida, United States
Research SiteRecruiting
Jacksonville, Florida, United States
Research SiteRecruiting
Leesburg, Florida, United States
Research SiteWithdrawn
Margate, Florida, United States
Research SiteRecruiting
Miami, Florida, United States
Research SiteRecruiting
Miami, Florida, United States
Research SiteSuspended
Miami Lakes, Florida, United States
Research SiteRecruiting
Ocala, Florida, United States
Research SiteRecruiting
Palmetto Bay, Florida, United States
Research SiteRecruiting
Winter Park, Florida, United States
Research SiteRecruiting
Adairsville, Georgia, United States
Research SiteRecruiting
Atlanta, Georgia, United States
Research SiteRecruiting
Cordele, Georgia, United States
Research SiteNot Yet Recruiting
Decatur, Georgia, United States
Research SiteWithdrawn
Fort Eisenhower, Georgia, United States
Research SiteRecruiting
Savannah, Georgia, United States
Research SiteNot Yet Recruiting
Evanston, Illinois, United States
Research SiteRecruiting
Evansville, Indiana, United States
Research SiteRecruiting
Indianapolis, Indiana, United States
Research SiteRecruiting
Indianapolis, Indiana, United States
Research SiteRecruiting
Kansas City, Kansas, United States
Research SiteRecruiting
Bowling Green, Kentucky, United States
Research SiteRecruiting
Owensboro, Kentucky, United States
Research SiteRecruiting
Baltimore, Maryland, United States
Research SiteRecruiting
Potomac, Maryland, United States
Research SiteRecruiting
Ann Arbor, Michigan, United States
Research SiteRecruiting
Minneapolis, Minnesota, United States
Research SiteRecruiting
Hannibal, Missouri, United States
Research SiteNot Yet Recruiting
Staten Island, New York, United States
Research SiteNot Yet Recruiting
Syracuse, New York, United States
Research SiteRecruiting
Charlotte, North Carolina, United States
Research SiteWithdrawn
Fayetteville, North Carolina, United States
Research SiteRecruiting
Oklahoma City, Oklahoma, United States
Research SiteRecruiting
Tulsa, Oklahoma, United States
Research SiteWithdrawn
Grants Pass, Oregon, United States
Research SiteNot Yet Recruiting
Sayre, Pennsylvania, United States
Research SiteRecruiting
Anderson, South Carolina, United States
Research SiteRecruiting
Columbia, South Carolina, United States
Research SiteRecruiting
Gaffney, South Carolina, United States
Research SiteRecruiting
Spartanburg, South Carolina, United States
Research SiteRecruiting
Union, South Carolina, United States
Research SiteRecruiting
Rapid City, South Dakota, United States
Research SiteRecruiting
Knoxville, Tennessee, United States
Research SiteRecruiting
Boerne, Texas, United States
Research SiteRecruiting
El Paso, Texas, United States
Research SiteRecruiting
Houston, Texas, United States
Research SiteRecruiting
Houston, Texas, United States
Research SiteNot Yet Recruiting
Houston, Texas, United States
Research SiteRecruiting
Lewisville, Texas, United States
Research SiteRecruiting
McKinney, Texas, United States
Research SiteRecruiting
Mesquite, Texas, United States
Research SiteNot Yet Recruiting
San Antonio, Texas, United States
Research SiteRecruiting
Colchester, Vermont, United States
Research SiteRecruiting
Williamsburg, Virginia, United States
Research SiteRecruiting
Everett, Washington, United States
Research SiteRecruiting
Alberdi, Argentina
Research SiteRecruiting
Buenos Aires, Argentina
Research SiteRecruiting
Ciudad de Buenos Aires, Argentina
Research SiteRecruiting
Florida, Argentina
Research SiteRecruiting
La Plata, Argentina
Research SiteRecruiting
La Plata, Argentina
Research SiteRecruiting
Mar del Plata, Argentina
Research SiteRecruiting
Mendoza, Argentina
Research SiteRecruiting
Quilmes, Argentina
Research SiteRecruiting
Rosario, Argentina
Research SiteRecruiting
San Fernando, Argentina
Research SiteRecruiting
San Juan Bautista, Argentina
Research SiteRecruiting
Coffs Harbour, Australia
Research SiteRecruiting
Frankston, Australia
Research SiteWithdrawn
Garran, Australia
Research SiteRecruiting
Nedlands, Australia
Research SiteRecruiting
New Lambton, Australia
Research SiteRecruiting
Spearwood, Australia
Research SiteWithdrawn
Wollongong, Australia
Research SiteRecruiting
Woodville South, Australia
Research SiteRecruiting
Genk, Belgium
Research SiteRecruiting
Ghent, Belgium
Research SiteRecruiting
Jette, Belgium
Research SiteRecruiting
Leuven, Belgium
Research SiteRecruiting
Mechelen, Belgium
Research SiteRecruiting
Namur, Belgium
Research SiteRecruiting
Dupnitsa, Bulgaria
Research SiteRecruiting
Haskovo, Bulgaria
Research SiteWithdrawn
Lovech, Bulgaria
Research SiteRecruiting
Pleven, Bulgaria
Research SiteRecruiting
Plovdiv, Bulgaria
Research SiteWithdrawn
Rousse, Bulgaria
Research SiteRecruiting
Rousse, Bulgaria
Research SiteRecruiting
Sofia, Bulgaria
Research SiteWithdrawn
Sofia, Bulgaria
Research SiteRecruiting
Sofia, Bulgaria
Research SiteRecruiting
Sofia, Bulgaria
Research SiteRecruiting
Stara Zagora, Bulgaria
Research SiteWithdrawn
Varna, Bulgaria
Research SiteRecruiting
Veliko Tanovo, Bulgaria
Research SiteRecruiting
Veliko Tarnovo, Bulgaria
Research SiteRecruiting
Vidin, Bulgaria
Research SiteRecruiting
Yambol, Bulgaria
Research SiteNot Yet Recruiting
Armenia, Colombia
Research SiteRecruiting
Barranquilla, Colombia
Research SiteRecruiting
Bogotá, Colombia
Research SiteRecruiting
Cali, Colombia
Research SiteRecruiting
Ibague, Colombia
Research SiteRecruiting
Manizales, Colombia
Research SiteRecruiting
Medellín, Colombia
Research SiteRecruiting
Medellín, Colombia
Research SiteRecruiting
Aalborg, Denmark
Research SiteRecruiting
Hvidovre, Denmark
Research SiteRecruiting
Næstved, Denmark
Research SiteRecruiting
Odense C, Denmark
Research SiteRecruiting
Vejle, Denmark
Research SiteRecruiting
Brest, France
Research SiteRecruiting
Lyon, France
Research SiteRecruiting
Marseille, France
Research SiteRecruiting
Montpellier, France
Research SiteRecruiting
Paris, France
Research SiteRecruiting
Paris, France
Research SiteRecruiting
Pessac, France
Research SiteRecruiting
Saint-Herblain, France
Research SiteRecruiting
Athens, Greece
Research SiteRecruiting
Athens, Greece
Research SiteRecruiting
Athens, Greece
Research SiteRecruiting
Heraklion, Greece
Research SiteRecruiting
Ioannina, Greece
Research SiteRecruiting
Pátrai, Greece
Research SiteRecruiting
Thessaloniki, Greece
Research SiteRecruiting
Thessaloniki, Greece
Research SiteRecruiting
Hong Kong, Hong Kong
Research SiteRecruiting
Hong Kong, Hong Kong
Research SiteRecruiting
Budapest, Hungary
Research SiteRecruiting
Debrecen, Hungary
Research SiteRecruiting
Edelény, Hungary
Research SiteRecruiting
Gödöllő, Hungary
Research SiteRecruiting
Hatvan, Hungary
Research SiteRecruiting
Mosonmagyaróvár, Hungary
Research SiteRecruiting
Nyíregyháza-Sóstóhegy, Hungary
Research SiteRecruiting
Törökbálint, Hungary
Research SiteRecruiting
Ashkelon, Israel
Research SiteRecruiting
Haifa, Israel
Research SiteRecruiting
Jerusalem, Israel
Research SiteRecruiting
Jerusalem, Israel
Research SiteRecruiting
Kfar Saba, Israel
Research SiteRecruiting
Ramat Gan, Israel
Research SiteRecruiting
Rehovot, Israel
Research SiteRecruiting
Tel Aviv, Israel
Research SiteRecruiting
Akashi-shi, Japan
Research SiteRecruiting
Chikushino-shi, Japan
Research SiteRecruiting
Chiyoda-ku, Japan
Research SiteRecruiting
Fukui-shi, Japan
Research SiteRecruiting
Fukuoka, Japan
Research SiteRecruiting
Fukuoka, Japan
Research SiteRecruiting
Gifu, Japan
Research SiteRecruiting
Iruma-Gun, Japan
Research SiteRecruiting
Ishinomaki, Japan
Research SiteRecruiting
Kasuga-shi, Japan
Research SiteRecruiting
Kitakyushu-shi, Japan
Research SiteRecruiting
Kiyose-shi, Japan
Research SiteRecruiting
Kiyose-shi, Japan
Research SiteRecruiting
Kobe, Japan
Research SiteRecruiting
Komatsu-shi, Japan
Research SiteRecruiting
Kure-shi, Japan
Research SiteRecruiting
Kyoto, Japan
Research SiteRecruiting
Matsusaka-shi, Japan
Research SiteWithdrawn
Meguro-ku, Japan
Research SiteRecruiting
Minatoku, Japan
Research SiteRecruiting
Minatoku, Japan
Research SiteRecruiting
Miyazaki, Japan
Research SiteRecruiting
Mizunami-shi, Japan
Research SiteRecruiting
Nagaoka-shi, Japan
Research SiteRecruiting
Nagasaki, Japan
Research SiteRecruiting
Nagoya, Japan
Research SiteRecruiting
Nagoya, Japan
Research SiteRecruiting
Nagoya, Japan
Research SiteRecruiting
Nerima-ku, Japan
Research SiteWithdrawn
Ohta-ku, Japan
Research SiteRecruiting
Okayama, Japan
Research SiteRecruiting
Okayama, Japan
Research SiteRecruiting
Osaka, Japan
Research SiteRecruiting
Sapporo, Japan
Research SiteRecruiting
Sendai, Japan
Research SiteRecruiting
Sendai, Japan
Research SiteRecruiting
Shinjuku-ku, Japan
Research SiteRecruiting
Shinjuku-ku, Japan
Research SiteRecruiting
Shinjuku-ku, Japan
Research SiteRecruiting
Shiogama, Japan
Research SiteRecruiting
Takamatsu, Japan
Research SiteWithdrawn
Takatsuiki-shi, Japan
Research SiteRecruiting
Tanabe-shi, Japan
Research SiteWithdrawn
Toshima-ku, Japan
Research SiteRecruiting
Ube, Japan
Research SiteRecruiting
Yokohama, Japan
Research SiteWithdrawn
Yokohama, Japan
Research SiteRecruiting
Eindhoven, Netherlands
Research SiteNot Yet Recruiting
Maastricht, Netherlands
Research SiteRecruiting
Rotterdam, Netherlands
Research SiteRecruiting
Rotterdam, Netherlands
Research SiteRecruiting
Zutphen, Netherlands
Research SiteRecruiting
Auckland, New Zealand
Research SiteRecruiting
Auckland, New Zealand
Research SiteRecruiting
Auckland, New Zealand
Research SiteRecruiting
Hamilton West, New Zealand
Research SiteRecruiting
Tauranga, New Zealand
Research SiteNot Yet Recruiting
Cusco, Peru
Research SiteNot Yet Recruiting
Lima, Peru
Research SiteWithdrawn
Lima, Peru
Research SiteRecruiting
Lima, Peru
Research SiteRecruiting
Lima, Peru
Research SiteRecruiting
Lima, Peru
Research SiteRecruiting
Lima, Peru
Research SiteWithdrawn
Lima, Peru
Research SiteRecruiting
Lima, Peru
Research SiteRecruiting
Piura, Peru
Research SiteWithdrawn
Bucharest, Romania
Research SiteSuspended
Bucharest, Romania
Research SiteRecruiting
Cluj-Napoca, Romania
Research SiteRecruiting
Cluj-Napoca, Romania
Research SiteRecruiting
Oradea, Romania
Research SiteRecruiting
Timișoara, Romania
Research SiteRecruiting
Timișoara, Romania
Research SiteRecruiting
Bellville, South Africa
Research SiteRecruiting
Benoni, South Africa
Research SiteRecruiting
Cape Town, South Africa
Research SiteRecruiting
Durban, South Africa
Research SiteRecruiting
Durban, South Africa
Research SiteRecruiting
eMkhomazi, South Africa
Research SiteRecruiting
Kimberley, South Africa
Research SiteRecruiting
Somerset West, South Africa
Research SiteRecruiting
Gothenburg, Sweden
Research SiteRecruiting
Karlskrona, Sweden
Research SiteRecruiting
Lund, Sweden
Research SiteRecruiting
Örebro, Sweden
Research SiteRecruiting
Stockholm, Sweden
Research SiteRecruiting
Stockholm, Sweden
Research SiteRecruiting
Bang Kra So, Thailand
Research SiteRecruiting
Bangkok, Thailand
Research SiteRecruiting
Hat Yai, Thailand
Research SiteRecruiting
Muang, Thailand
Research SiteRecruiting
Muang, Thailand
Research SiteRecruiting
Mueang, Thailand
Research SiteRecruiting
Rayong, Thailand
Research SiteRecruiting
Adana, Turkey (Türkiye)
Research SiteRecruiting
Ankara, Turkey (Türkiye)
Research SiteRecruiting
Istanbul, Turkey (Türkiye)
Research SiteRecruiting
Kayseri, Turkey (Türkiye)
Research SiteRecruiting
Kocaeli, Turkey (Türkiye)
Research SiteRecruiting
Mersin, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Can Tho, Vietnam
Research SiteRecruiting
Da Nang, Vietnam
Research SiteRecruiting
Haiphong, Vietnam
Research SiteRecruiting
Hanoi, Vietnam
Research SiteRecruiting
Ho Chi Minh City, Vietnam
Research SiteNot Yet Recruiting
Ho Chi Minh City, Vietnam
Research SiteNot Yet Recruiting
Ho Chi Minh City, Vietnam
Research SiteRecruiting
Hồ Chí Minh, Vietnam
Research SiteRecruiting
Huế, Vietnam