A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

NCT06878261 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D5241C00007
• Study Type: interventional
• Target: 990
• Locations: 22 countries
• Sites: 268

Brief Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Moderate COPD; Severe COPD; Very Severe COPD; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Annualised rate of moderate or severe COPD exacerbations

  The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

  Baseline up to 76 weeks

Secondary Outcomes (13)

• Change from baseline in post-BD FEV1

  From baseline to Week 52

• Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

  From baseline to Week 52

• Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score

  From baseline over 52 weeks

• Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.

  Baseline up to 76 weeks

• Annualised rate of severe COPD exacerbations

  Baseline up to 76 weeks

Study Arms (3)

Dose 1 of Tezepelumab

EXPERIMENTAL

Tezepelumab, SC, Q4W

Biological: Tezepelumab

Dose 2 of Tezepelumab

EXPERIMENTAL

Tezepelumab, SC, Q4W

Biological: Tezepelumab

Matching Placebo

PLACEBO COMPARATOR

Matching placebo, SC, Q4W

Other: Placebo

Interventions

Tezepelumab BIOLOGICAL

Tezepelumab subcutaneous injection

Dose 1 of Tezepelumab; Dose 2 of Tezepelumab

Placebo OTHER

Placebo subcutaneous injection

Matching Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥40 to ≤80 years old
• COPD diagnosis ≥1 year,
• Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
• Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
• ≥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
• EOS ≥ 150 cells/μL during screening
• CAT ≥15 at screening
• Former or current smokers ≥10 pack-years

You may not qualify if:

• Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
• Asthma, incl. pediatric, or ACOS
• Any unstable disorder that can impact participants safety or study outcomes
• Tuberculosis requiring treatment within 12 months prior V2
• Malignancies current or past
• Concomitant therapies:
• Macrolides (less than 6 months)
• Systemic immuno-suppressive, -modulating medications
• LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Sponsors & Collaborators

• AstraZeneca: lead
• Amgen: collaborator

Study Sites (268)

Research Site

Cullman, Alabama, 35055, United States

RECRUITING

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Phoenix, Arizona, 85044, United States

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Scottsdale, Arizona, 85258, United States

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Inglewood, California, 90301, United States

WITHDRAWN

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Los Angeles, California, 90048, United States

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Palo Alto, California, 94304, United States

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Redding, California, 96001, United States

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San Diego, California, 92108, United States

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New Britain, Connecticut, 06051, United States

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Wilmington, Delaware, 19803, United States

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Bay Pines, Florida, 33744, United States

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Boynton Beach, Florida, 33435, United States

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Clearwater, Florida, 33765, United States

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Fleming Island, Florida, 32003, United States

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Jacksonville, Florida, 32209, United States

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Leesburg, Florida, 34748, United States

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Margate, Florida, 33063, United States

WITHDRAWN

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Miami, Florida, 33126, United States

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Miami, Florida, 33155, United States

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Miami Lakes, Florida, 33014, United States

SUSPENDED

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Ocala, Florida, 34470, United States

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Palmetto Bay, Florida, 33157, United States

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Winter Park, Florida, 32789, United States

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Adairsville, Georgia, 30103, United States

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Atlanta, Georgia, 30349, United States

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Cordele, Georgia, 31015, United States

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Decatur, Georgia, 30033, United States

NOT YET RECRUITING

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Fort Eisenhower, Georgia, 30905, United States

WITHDRAWN

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Savannah, Georgia, 31406, United States

RECRUITING

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Evanston, Illinois, 60201, United States

NOT YET RECRUITING

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Evansville, Indiana, 47725, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46268, United States

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Kansas City, Kansas, 66160, United States

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Bowling Green, Kentucky, 42101, United States

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Owensboro, Kentucky, 42301, United States

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Baltimore, Maryland, 21224, United States

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Potomac, Maryland, 20854, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55425, United States

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Hannibal, Missouri, 63401, United States

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Staten Island, New York, 10309, United States

NOT YET RECRUITING

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Syracuse, New York, 13203, United States

NOT YET RECRUITING

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Charlotte, North Carolina, 28277, United States

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Fayetteville, North Carolina, 28303, United States

WITHDRAWN

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Oklahoma City, Oklahoma, 73102, United States

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Tulsa, Oklahoma, 74133, United States

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Grants Pass, Oregon, 97527, United States

WITHDRAWN

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Sayre, Pennsylvania, 18840, United States

NOT YET RECRUITING

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Anderson, South Carolina, 29621, United States

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Columbia, South Carolina, 29204, United States

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Gaffney, South Carolina, 29340, United States

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Spartanburg, South Carolina, 29303, United States

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Union, South Carolina, 29379, United States

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Rapid City, South Dakota, 57702, United States

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Knoxville, Tennessee, 37919, United States

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Boerne, Texas, 78006, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77094, United States

NOT YET RECRUITING

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Lewisville, Texas, 75067, United States

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McKinney, Texas, 75069, United States

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Mesquite, Texas, 75149, United States

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San Antonio, Texas, 78258, United States

NOT YET RECRUITING

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Colchester, Vermont, 05446, United States

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Williamsburg, Virginia, 23188, United States

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Everett, Washington, 98208, United States

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Alberdi, X5033DCE, Argentina

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Buenos Aires, C1425BEN, Argentina

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Ciudad de Buenos Aires, C1414AIF, Argentina

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Florida, B1602DQD, Argentina

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La Plata, B1900, Argentina

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La Plata, B1904, Argentina

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Mar del Plata, 7600, Argentina

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Mendoza, M5500CCG, Argentina

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Quilmes, B1878FNR, Argentina

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Rosario, 2000, Argentina

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San Fernando, B1646EBJ, Argentina

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San Juan Bautista, 1888, Argentina

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Coffs Harbour, 02450, Australia

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Frankston, 3199, Australia

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Garran, 2605, Australia

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Nedlands, 6009, Australia

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New Lambton, 2310, Australia

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Spearwood, 6163, Australia

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Wollongong, 2500, Australia

WITHDRAWN

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Woodville South, 5011, Australia

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Jette, 1090, Belgium

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Leuven, 3000, Belgium

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Mechelen, 2800, Belgium

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Namur, 5101, Belgium

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Dupnitsa, 2600, Bulgaria

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Haskovo, 6300, Bulgaria

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Lovech, 5500, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4003, Bulgaria

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Rousse, 7000, Bulgaria

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Rousse, 7000, Bulgaria

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Sofia, 1000, Bulgaria

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Sofia, 1202, Bulgaria

WITHDRAWN

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Sofia, 1431, Bulgaria

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Sofia, 1756, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Varna, 9000, Bulgaria

WITHDRAWN

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Veliko Tanovo, 5000, Bulgaria

RECRUITING

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Veliko Tarnovo, 5000, Bulgaria

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Vidin, 3700, Bulgaria

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Yambol, 8600, Bulgaria

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Armenia, 630004, Colombia

NOT YET RECRUITING

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Barranquilla, 080020, Colombia

RECRUITING

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Bogotá, 110131, Colombia

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Cali, 760042, Colombia

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Ibagué, 730006, Colombia

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Manizales, 170004, Colombia

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Medellín, 050022, Colombia

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Medellín, 050030, Colombia

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Aalborg, 9000, Denmark

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Hvidovre, 2650, Denmark

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Næstved, 4700, Denmark

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Odense C, 5000, Denmark

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Vejle, 7100, Denmark

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Brest, 29609, France

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Lyon, 69317, France

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Marseille, 13915, France

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Montpellier, 34295, France

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Paris, 75014, France

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Paris, 75877, France

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Pessac, 33604, France

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Saint-Herblain, 44800, France

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Athens, 11521, Greece

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Athens, 11527, Greece

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Athens, 17562, Greece

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Heraklion, 71110, Greece

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Ioannina, 45500, Greece

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Pátrai, 26332, Greece

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Thessaloniki, 57001, Greece

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Thessaloniki, 57010, Greece

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Hong Kong, 999077, Hong Kong

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Hong Kong, Hong Kong

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Budapest, 1036, Hungary

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Debrecen, 4032, Hungary

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Edelény, 3780, Hungary

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Gödöllő, 2100, Hungary

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Hatvan, 3000, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Nyíregyháza-Sóstóhegy, 4481, Hungary

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Törökbálint, 2045, Hungary

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Ashkelon, 78278, Israel

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Haifa, 34362, Israel

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Jerusalem, 00000, Israel

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Jerusalem, 90131, Israel

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Kfar Saba, 4428164, Israel

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Ramat Gan, 52621, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 6423906, Israel

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Akashi-shi, 674-0063, Japan

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Chikushino-shi, 818-8502, Japan

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Chiyoda-ku, 1020074, Japan

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Fukui-shi, 910-8526, Japan

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Fukuoka, 811-1394, Japan

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Fukuoka, 819-8555, Japan

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Gifu, 502-8558, Japan

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Iruma-Gun, 350-0495, Japan

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Ishinomaki, 986-8522, Japan

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Kasuga-shi, 816-0864, Japan

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Kitakyushu-shi, 807-8555, Japan

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Kiyose-shi, 204-8522, Japan

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Kiyose-shi, 204-8585, Japan

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Kobe, 650-0047, Japan

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Komatsu-shi, 923-8560, Japan

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Kure-shi, 737-8505, Japan

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Kyoto, 612-8555, Japan

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Matsusaka-shi, 515-8544, Japan

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Meguro-ku, 153-0051, Japan

WITHDRAWN

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Minatoku, 105-8470, Japan

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Minatoku, 108-0073, Japan

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Miyazaki, 889-1692, Japan

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Mizunami-shi, 509-6134, Japan

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Nagaoka-shi, 940-8621, Japan

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Nagasaki, 852-8501, Japan

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Nagoya, 457-0866, Japan

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Nagoya, 457-8511, Japan

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Nagoya, 466-8650, Japan

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Nerima-ku, 177-8521, Japan

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Ohta-ku, 143-0013, Japan

WITHDRAWN

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Okayama, 700-8558, Japan

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Okayama, 701-1192, Japan

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Osaka, 540-0008, Japan

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Sapporo, 064-0804, Japan

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Sendai, 980-8574, Japan

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Sendai, 983-8520, Japan

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Shinjuku-ku, 160-8582, Japan

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Shinjuku-ku, 162-8655, Japan

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Shinjuku-ku, 162-8666, Japan

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Shiogama, 985-8506, Japan

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Takamatsu, 760-0018, Japan

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Takatsuiki-shi, 569-1096, Japan

WITHDRAWN

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Tanabe-shi, 646-8558, Japan

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Toshima-ku, 171-0014, Japan

WITHDRAWN

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Ube, 755-8505, Japan

RECRUITING

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Yokohama, 236-0004, Japan

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Yokohama, 245-8575, Japan

WITHDRAWN

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Eindhoven, 5623 EJ, Netherlands

RECRUITING

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Maastricht, 6229 HX, Netherlands

NOT YET RECRUITING

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Rotterdam, 3045 PM, Netherlands

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Rotterdam, 3083 AN, Netherlands

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Zutphen, 7207 AE, Netherlands

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Auckland, 0626, New Zealand

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Auckland, 1051, New Zealand

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Auckland, 2025, New Zealand

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Hamilton West, 3204, New Zealand

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Tauranga, 3112, New Zealand

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Cusco, CUSCO 01, Peru

NOT YET RECRUITING

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Lima, 15036, Peru

NOT YET RECRUITING

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Lima, 15036, Peru

WITHDRAWN

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Lima, 15046, Peru

RECRUITING

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Lima, 15088, Peru

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Lima, LIMA 01, Peru

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Lima, LIMA 1, Peru

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Lima, LIMA 21, Peru

WITHDRAWN

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Lima, LIMA 33, Peru

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Piura, 20001, Peru

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Bucharest, 011461, Romania

WITHDRAWN

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Bucharest, 050159, Romania

SUSPENDED

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Cluj-Napoca, 400275, Romania

RECRUITING

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Cluj-Napoca, 400332, Romania

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Oradea, 410176, Romania

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Timișoara, 300002, Romania

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Timișoara, 300310, Romania

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Bellville, 7530, South Africa

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Benoni, 1501, South Africa

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Cape Town, 7700, South Africa

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Durban, 4001, South Africa

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Durban, 4093, South Africa

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eMkhomazi, 4170, South Africa

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Kimberley, 8301, South Africa

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Somerset West, 7130, South Africa

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Gothenburg, 413 46, Sweden

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Karlskrona, 371 79, Sweden

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Lund, 22185, Sweden

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Örebro, 703 62, Sweden

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Stockholm, 11446, Sweden

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Stockholm, 171 64, Sweden

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Bang Kra So, 11000, Thailand

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Bangkok, 10330, Thailand

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Hat Yai, 90110, Thailand

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Muang, 22000, Thailand

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Muang, 40002, Thailand

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Mueang, 20000, Thailand

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Rayong, 21000, Thailand

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Adana, 1330, Turkey (Türkiye)

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Ankara, 6620, Turkey (Türkiye)

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Istanbul, 34020, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Mersin, 33079, Turkey (Türkiye)

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Can Tho, 900000, Vietnam

NOT YET RECRUITING

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Da Nang, 550000, Vietnam

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Haiphong, 180000, Vietnam

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Hanoi, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Research Site

Ho Chi Minh City, 700000, Vietnam

NOT YET RECRUITING

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Ho Chi Minh City, Vietnam

NOT YET RECRUITING

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Hồ Chí Minh, 700000, Vietnam

RECRUITING

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Huế, 530000, Vietnam

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MeiLan Han, MD

  University of Michigan Health, Pulmonary & Critical Care Medicine,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a ratio of 1:1:1 to receive Dose 1 of tezepelumab, Dose 2 of tezepelumab or matching placebo.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 14, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 13, 2029
• Study Completion (Estimated): June 5, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

JP (47); HU (8); BE (6); AU (8); CO (8); FR (8); NZ (5); ZA (8); HK (2); TU (6); VN (9); NL (5); DK (5); BU (17); PE (10); TH (7); GR (8); SE (6); IL (8); AR (12); RO (7); US (68)