A Study to Investigate Efficacy and Safety of Tozorakimab Injections Compared With Placebo in Adult Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils

Last updated: April 28, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Bronchiectasis

Emphysema

Chronic Obstructive Pulmonary Disease (Copd)

Treatment

Tozorakimab

Placebo

Clinical Study ID

NCT06897748
AZ-RU-00008
  • Ages > 40
  • All Genders

Study Summary

The purpose of this study is to investigate lung function parameters, composite endpoint for exacerbations in chronic obstructive pulmonary disease (COPDCompEx), symptoms and to provide safety information after tozorakimab or placebo administrations in participants with symptomatic chronic obstructive pulmonary disease (COPD) with history of exacerbations and high blood eosinophil counts.

Study details include the following:

  • The maximum duration of the screening/run-in period is 5 weeks. An additional unscheduled visit may be performed prior to randomization to repeat safety assessments as deemed necessary by the investigator.

  • Eligible patients will enter 12-week treatment (intervention) period with site visits and investigational product (IP) administration every 2 weeks.

  • Participants who complete a treatment period, and have not been prematurely discontinued from IP, will enter a 10-week post-intervention follow-up period.

  • The study duration will be 27 weeks at maximum for each participant.

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% and < 80% of predicted normal value.

  4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 monthsprior to enrolment.

  5. Documented optimised inhaled dual or triple therapy for at least 3 months prior toenrolment.

  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.

  8. All participants must have eosinophil blood count ≥ 150 cells/µL.

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. Radiologicalfindings of pulmonary nodules suspicious for lung cancer, as per applicableguidances, without appropriate follow up prior to randomisation. Radiologicalfindings 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 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. Significant COVID-19 illness within the 6 months prior to enrolment.

  8. Unstable cardiovascular disorder.

  9. Diagnosis of clinically significant cor pulmonale, pulmonary arterial hypertensionand/or right ventricular failure.

  10. History of active severe inflammatory bowel disease or colitis within one year priorto enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.

  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, in the opinion of the Investigator or qualified designee, haveevidence of active TB.

  16. History of partial or total lung resection.

  17. Scheduled major surgical procedure during the course of the study.

  18. Participants that have previously received tozorakimab.

  19. Change in smoking status in 12 weeks prior to enrolment or intention to changesmoking status between enrolment and end of follow-up.

  20. 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.

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: Tozorakimab
Phase: 2
Study Start date:
April 12, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Research Site

    Izhevsk, 426061
    Russian Federation

    Active - Recruiting

  • Research Site

    Moscow, 105554
    Russian Federation

    Active - Recruiting

  • Research Site

    Omsk, 644099
    Russian Federation

    Site Not Available

  • Research Site

    Penza, 440067
    Russian Federation

    Active - Recruiting

  • Research Site

    Perm, 614000
    Russian Federation

    Active - Recruiting

  • Research Site

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Research Site

    St-Petersburg, 193231
    Russian Federation

    Site Not Available

  • Research Site

    Ulyanovsk, 432009
    Russian Federation

    Active - Recruiting

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