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Search / Trial NCT06878261

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 April 29, 2025

Recruiting

Keywords

Copd Moderate Copd Severe Copd Very Severe Copd Chronic Obstructive Pulmonary Disease

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.

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

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

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

Thessaloniki, , Greece

Odense C, , Denmark

Montpellier Cedex 5, , France

Dupnitsa, , Bulgaria

Yambol, , Bulgaria

Kasuga Shi, , Japan

Yokohama Shi, , Japan

Hanoi, , Vietnam

Mosonmagyaróvár, , Hungary

Ho Chi Minh, , Vietnam

Edelény, , Hungary

Charlotte, North Carolina, United States

Tulsa, Oklahoma, United States

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

Gödöllő, , Hungary

Kiyose Shi, , Japan

Toshima Ku, , Japan

Evansville, Indiana, United States

Lyon Cedex 04, , France

Tempe, Arizona, United States

Hatvan, , Hungary

Meguro Ku, , Japan

Frankston, , Australia

Fukuoka Shi, , Japan

Vidin, , Bulgaria

Næstved, , Denmark

Marseille, , France

Hamilton West, , New Zealand

Barranquilla, , Colombia

Nagoya Shi, , Japan

Lima, , Peru

Lewisville, Texas, United States

Williamsburg, Virginia, United States

Paris Cedex 18, , France

Kure Shi, , Japan

Benoni, , South Africa

Manizales, , Colombia

Miyazaki Shi, , Japan

Owensboro, Kentucky, United States

Namur, , Belgium

Akashi Shi, , Japan

Spearwood, , Australia

Ube, , Japan

Adairsville, Georgia, United States

Ibague, , Colombia

Auckland, , New Zealand

Pleven, , Bulgaria

Muang, , Thailand

Minneapolis, Minnesota, United States

Hannibal, Missouri, United States

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

Cali, , Colombia

Ocala, Florida, United States

Potomac, Maryland, United States

Patra, , Greece

Fayetteville, North Carolina, United States

Minato Ku, , Japan

Veliko Tanovo, , Bulgaria

Hong Kong, , Hong Kong

Nyíregyháza Sóstóhegy, , Hungary

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

Patients applied

0 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