Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

Last updated: July 10, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Bronchiectasis

Emphysema

Chronic Obstructive Lung Disease

Treatment

Placebo

Tozorakimab

Clinical Study ID

NCT05166889
D9180C00003
2023-503571-19-00
2021-003797-30
  • Ages 40-130
  • All Genders

Study Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

Eligibility Criteria

Inclusion

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 monthsprior to enrolment.

  5. Documented optimized inhaled dual or triple therapy at a stable dose for at least 3months 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 ≥

Exclusion

Exclusion Criteria:

  1. Clinically important pulmonary disease other than COPD.

  2. Radiological findings suggestive of a respiratory disease other than COPD that issignificantly contributing to the participant's respiratory symptoms.

  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 resolvedbefore 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/orcognitive impairment that could affect safety, study findings or participantsability to complete the study.

  5. COPD exacerbation, within 2 weeks prior to randomization, that was treated withsystemic corticosteroids and/or antibiotics, and/or led to hospitalization.

  6. Active significant infection within the 4 weeks prior to randomization, pneumoniawithin 6 weeks prior to randomization, or medical condition that predisposes theparticipant 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 ventricularfailure.

  11. History of known immunodeficiency disorder, including a positive test for HIV-1 orHIV 2.

  12. History of positive test or treatment for hepatitis B or hepatitis C (except forcured hepatitis C)

  13. Evidence of active liver disease, including jaundice during screening.

  14. Malignancy, current or within the past 5 years, except for adequately treatednon-invasive basal cell and squamous cell carcinoma of the skin and cervicalcarcinoma-in-situ treated with apparent success more than one year prior toenrolment. Suspected malignancy or undefined neoplasms.

  15. Participants who have evidence of active TB.

  16. Participants that have previously received tozorakimab.

  17. Any clinically significant abnormal findings in physical examination, vital signs,ECG, or laboratory testing during the screening period, which in the opinion of theinvestigator may put the participant at risk because of their participation in thestudy, or may influence the results of the study, or the participant's ability tocomplete the entire duration of the study.

  18. Active vaping of any products or using smoked marijuana within the 6 months prior torandomization and during the study.

Study Design

Total Participants: 1132
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 03, 2022
Estimated Completion Date:
March 23, 2026

Connect with a study center

  • Research Site

    Buenos Aires, C1121 ABE
    Argentina

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    Caba, C1425BEN
    Argentina

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    Córdoba, X5003DCE
    Argentina

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    Florencio Varela, 1888
    Argentina

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    Mar del Plata, 7600
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    Mendoza, M5500CCG
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    Quilmes, B1878FNR
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    Ranelagh, 1886
    Argentina

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    San Fernando, B1646EBJ
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    San Miguel de Tucuman, 4000
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    Tucumán, 4000
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    Bruxelles, 1000
    Belgium

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    Edegem, 2650
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    Gent, 9000
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    Leuven, 3000
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    Liege, 4000
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    Roeselare, 8800
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    Dupnitsa, 2600
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    Kozloduy, 3320
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    Lovech, 5500
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    Petrich, 2850
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    Pleven, 5800
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    Ruse, 7002
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    Obihiro, 080-0017
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    Osaka-shi, 543-8555
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    Sakai-shi, 590-0064
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    Sakaide-shi, 762-0031
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    Toyama-shi, 930-8550
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    Toyonaka-shi, 560-8552
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    Wakayama-shi, 640-8505
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    Yamagata-shi, 990-9585
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    Yanagawa-shi, 832-0059
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    Yokohama-shi, 221-0855
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    Daegu, 42415
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    Incheon, 21431
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    Jeonju-si, 54907
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    Benito Juarez, 03650
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    Chihuahua, 31000
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    Ecatepec de Morelos, 55450
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    Guadalajara, 44200
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    United States

    Site Not Available

  • Research Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Research Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Research Site

    DuBois, Pennsylvania 15801
    United States

    Site Not Available

  • Research Site

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Research Site

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Research Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Research Site

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Research Site

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Research Site

    Cleveland, Texas 77327
    United States

    Site Not Available

  • Research Site

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77022
    United States

    Site Not Available

  • Research Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research Site

    Sherman, Texas 75092
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Research Site

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Research Site

    Colchester, Vermont 05446
    United States

    Site Not Available

  • Research Site

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Research Site

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 123
    Vietnam

    Site Not Available

  • Research Site

    Hochiminh, 70000
    Vietnam

    Site Not Available

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