New shot aims to cut dangerous COPD attacks in high-risk patients

NCT ID NCT06040086

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests an investigational drug called tozorakimab in about 1,454 adults with symptomatic COPD who have had at least two moderate or one severe flare-up in the past year. Participants continue their usual inhaled medications and receive either tozorakimab or a placebo as a shot. The main goal is to see if the drug reduces the number of moderate-to-severe COPD exacerbations over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,454 people

The number who actually took part.

Started

Sep 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be ≥ 40 years of age and capable of giving signed informed consent. 2. Documented diagnosis of COPD for at least one year prior to enrolment. 3. Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value 4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. 5. Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment. 6. Smoking history of ≥ 10 pack-years. 7. CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2 Exclusion Criteria: 1. Clinically important pulmonary disease other than COPD. 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection. 3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18 4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study. 5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization. 6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection. 7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection. 8. Significant COVID-19 illness within the 6 months prior to enrolment. 9. Unstable cardiovascular disorder. 10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure. 11. History of active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation. 12. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2. 13. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C) 14. Evidence of active liver disease, including jaundice during screening. 15. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms. 16. Participants who have evidence of active TB. 17. History of partial or total lung resection. 18. Scheduled major surgical procedure during the course of the study. 19. Participants that have previously received tozorakimab. 20. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease (COPD)

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35205, United States
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Decatur, Alabama, 35603, United States
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Sheffield, Alabama, 35660, United States
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Phoenix, Arizona, 85027, United States
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Tucson, Arizona, 85704, United States
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Yuma, Arizona, 85365, United States
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Los Angeles, California, 90027, United States
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Newport Beach, California, 92663, United States
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San Francisco, California, 94109, United States
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Westminster, California, 92683, United States
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Aurora, Colorado, 80014, United States
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Boulder, Colorado, 80301, United States
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Washington D.C., District of Columbia, 20037, United States
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Boynton Beach, Florida, 33435, United States
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Cape Coral, Florida, 33990, United States
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Lakeland, Florida, 33805, United States
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Lakeland, Florida, 33813, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34470, United States
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Ormond Beach, Florida, 32174, United States
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Atlanta, Georgia, 30344, United States
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Lithonia, Georgia, 30038, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, 60616, United States
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Andover, Kansas, 67002, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40503, United States
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Towson, Maryland, 21286, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55425, United States
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Chesterfield, Missouri, 63005, United States
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Chesterfield, Missouri, 63017, United States
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Hannibal, Missouri, 63401, United States
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Papillion, Nebraska, 68046, United States
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Las Vegas, Nevada, 89102, United States
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Toms River, New Jersey, 08755, United States
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The Bronx, New York, 10451, United States
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Charlotte, North Carolina, 28273, United States
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Greenville, North Carolina, 27834, United States
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Huntersville, North Carolina, 28078, United States
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Winston-Salem, North Carolina, 27103, United States
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Dayton, Ohio, 45439, United States
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Lima, Ohio, 45801, United States
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Grants Pass, Oregon, 97527, United States
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Gaffney, South Carolina, 29340, United States
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Union, South Carolina, 29379, United States
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Chattanooga, Tennessee, 37404, United States
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Elizabethton, Tennessee, 37643, United States
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Jackson, Tennessee, 38305, United States
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Dallas, Texas, 75254, 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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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78258, United States
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Roy, Utah, 84067, United States
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Kenosha, Wisconsin, 53142, United States
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Buenos Aires, C1121 ABE, Argentina
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CABA, C1025ABI, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, C1414AIF, Argentina
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Córdoba, X5003DCE, Argentina
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La Plata, B1904, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600GWV, Argentina
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Mendoza, M5500CCG, Argentina
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Quilmes, B1878FNR, Argentina
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San Fernando, B1646EBJ, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Brussels, 1070, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, 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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Roeselare, 8800, Belgium
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30150-221, Brazil
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Blumenau, 89030-101, Brazil
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Campina Grande do Sul, 83.430-000, Brazil
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Campinas, 13060-080, Brazil
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Fortaleza, 60430-270, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91010-006, Brazil
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São Bernardo do Campo, 09715090, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 05403-000, Brazil
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Valinhos, 13271-130, Brazil
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6300, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Plovdiv, 4003, Bulgaria
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Sofia, 1756, Bulgaria
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Veliko Tanovo, 5000, Bulgaria
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Yambol, 8600, Bulgaria
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Calgary, Alberta, T3R 1W7, Canada
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Kelowna, British Columbia, V1Y 4N7, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Winchester, Ontario, K0C 2K0, Canada
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Lévis, Quebec, G6V 0C9, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Chile, 7770484, Chile
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Concepción, 4070094, Chile
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Quillota, 2260000, Chile
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Santiago, 7500010, Chile
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Santiago, 7501126, Chile
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Santiago, 7750495, Chile
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Santiago, 8380453, Chile
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Viña del Mar, 2540488, Chile
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Beijing, 100029, China
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Changchun, 130021, China
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Changsha, 410015, China
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Changsha, 430033, China
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Chengdu, 610014, China
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Chengdu, 610072, China
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Chengdu, 611130, China
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Chongqing, 400037, China
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Chongqing, 400042, China
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Guangzhou, 510145, China
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Guangzhou, 510163, China
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Guangzhou, 510515, China
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Hefei, 230061, China
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Hohhot, 750306, China
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Huizhou, 516002, China
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Jinan, 250001, China
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Lanzhou, 730030, China
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Liaocheng, 252000, China
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Linhai, 317000, China
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Nanchang, 330006, China
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Nanchong, 637000, China
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Nanjing, 210006, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Ningbo, 315010, China
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Pingxiang, 337055, China
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Qingdao, 266000, China
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Shanghai, 200040, China
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Shanghai, 200240, China
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Shanghai, 200433, China
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Shanghai, 201199, China
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Shenyang, 110004, China
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Shenyang, 110016, China
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Shenzhen, 518020, China
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Shijiazhuang, 050051, China
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Shijiazhuang, 50051, China
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Taizhou, 318000, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xi'an, 710006, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yinchuan, 750004, China
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Zigong, 643000, China
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Aalborg, 9000, Denmark
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Aarhus, 8200, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Næstved, 4700, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Aix-en-Provence, 13100, France
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Brest, 29609, France
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Colmar, 68024, France
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Epagny Metz-Tessy, 74370, France
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La Tronche, 38700, France
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Lyon, 69317, France
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Marseille, 13015, France
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Montpellier, 34295, France
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Quimper, 29000, France
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Reims, 51092, France
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Villefranche-sur-Saône, 69655, France
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Augsburg, 86150, Germany
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Berlin, 10119, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 10961, Germany
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Berlin, 12157, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Cologne, 51069, Germany
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Darmstadt, 64283, Germany
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Essen, 45127, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Großhansdorf, 22927, Germany
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Halle, 06108, Germany
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Halle, 06120, Germany
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Hanover, 30159, Germany
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Leipzig, 04299, Germany
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Marburg, 35037, Germany
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Moers, 47441, Germany
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München, 80335, Germany
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München-Pasing, 81241, Germany
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Nuremberg, 90419, Germany
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Peine, 31224, Germany
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Solingen, 42699, Germany
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Athens, 11521, Greece
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Athens, 17562, Greece
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Heraklion, 71409, Greece
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Thessaloniki, 57010, Greece
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Budapest, 1203, Hungary
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Debrecen, 4032, Hungary
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Edelény, 3780, Hungary
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Encs, 3860, Hungary
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Gödöllő, 2100, Hungary
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Hajdúnánás, 4080, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Pécs, 7635, Hungary
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Százhalombatta, 2440, Hungary
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Szolnok, 5000, Hungary
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Ajmer, 305001, India
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Calicut, 673 008, India
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Dehradun, 248001, India
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Delhi, 110029, India
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Dwārka, 110075, India
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Hyderabad, 500035, India
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Hyderabad, 500038, India
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Jaipur, 302012, India
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Jaipur, 302039, India
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Kolkata, 700053, India
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Nagpur, 440012, India
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Vijayawada, 520 008, India
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Visakhapatnam, 530017, India
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Cork, T12 DV56, Ireland
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Dublin, D24 NR0A, Ireland
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Galway, H91 YR71, Ireland
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Moneymore, A92 VW28, Ireland
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Cona, 44124, Italy
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Foggia, 71100, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Pisa, 56100, Italy
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Roma, 161, Italy
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Aomori, 030-8553, Japan
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Asahikawa-shi, 070-8644, Japan
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Chikushino-shi, 818-8502, Japan
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Chūōku, 104-0031, Japan
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Fujieda-shi, 426-8677, Japan
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Fukuoka, 814-0180, Japan
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Ginowan-shi, 901-2214, Japan
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Habikino-shi, 583-8588, Japan
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Hakodate-shi, 041-8680, Japan
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Hamamatsu, 430-8525, Japan
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Itabashi-ku, 173-8610, Japan
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Izumi-shi, 594-0073, Japan
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Kagoshima, 892-0847, Japan
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Kobe, 650-0047, Japan
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Kusatsu-shi, 525-8585, Japan
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Kyoto, 612-8555, Japan
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Matsusaka-shi, 515-8544, Japan
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Minoh, 562-0003, Japan
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Minokamo Shi, 505-8510, Japan
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Mizunami-shi, 509-6134, Japan
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Morioka, 020-0066, Japan
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Nagoya, 457-8511, Japan
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Nankoku-shi, 783-8505, Japan
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Nankoku-shi, 783-8509, Japan
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Omuta-shi, 837-0911, Japan
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Sagamihara-shi, 252-0143, Japan
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Sagamihara-shi, 252-0315, Japan
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Sakaide-shi, 762-8550, Japan
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Sapporo, 006-8555, Japan
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Sapporo, 064-0804, Japan
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Shizuoka, 420-8630, Japan
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Tachikawa-shi, 190-8531, Japan
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Toon-shi, 791-0281, Japan
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Toshima-ku, 171-0014, Japan
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Toyonaka-shi, 560-8552, Japan
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Ube, 755-8505, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 221-0855, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 232-0066, Japan
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Yokohama, 236-0037, Japan
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Alor Star, 5460, Malaysia
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Kajang, 43000, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Seremban, 70300, Malaysia
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Mexico City, 03310, Mexico
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's-Hertogenbosch, 5223 GZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Breda, 4818 CK, Netherlands
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Heerlen, 6419 PC, Netherlands
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Roermond, 6043 CV, Netherlands
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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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Lima, 15046, Peru
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Lima, 15102, Peru
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Lima, LIMA 21, Peru
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Piura, 20001, Peru
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Santa Beatriz, LIMA 14, Peru
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Bialystok, 15-044, Poland
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Bydgoszcz, 85-796, Poland
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Chrzanów, 32-500, Poland
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Kielce, 25-426, Poland
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Krakow, 30-033, Poland
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Krakow, 31-513, Poland
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Pruszków, 05-800, Poland
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Płock, 09-407, Poland
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Rzeszów, 35-205, Poland
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Anyang-si, 14068, South Korea
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Daegu, 42415, South Korea
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Incheon, 21565, South Korea
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Jeonju, 54907, South Korea
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Seoul, 04763, South Korea
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Seoul, 05030, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 06973, South Korea
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Wŏnju, 26426, South Korea
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Badalona(Barcelona), 08916, Spain
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Barcelona, 08035, Spain
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Cáceres, 10003, Spain
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Madrid, 28850, Spain
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Málaga, 29010, Spain
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Mérida, 06800, Spain
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Santander, 39008, Spain
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Zaragoza, 50009, Spain
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Hat Yai, 90110, Thailand
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Khlong Luang, 12120, 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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Nakhon Ratchasima, 30000, Thailand
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Adana, 1330, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Chernivtsi, 58022, Ukraine
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Ivano-Frankivsk, 76019, Ukraine
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Kyiv, 02002, Ukraine
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Kyiv, 02081, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03680, Ukraine
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Tarasove Village, 45634, Ukraine
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Ternopil, 46001, Ukraine
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Uzhhorod, 88018, Ukraine
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Vinnytsia, 21001, Ukraine
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Vinnytsia, 21029, Ukraine
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Zhytomyr, 100002, Ukraine
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Bradford, BD9 6RJ, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, NW3 2QG, United Kingdom
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Macclesfield, SK10 3BL, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh, 70000, Vietnam

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