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Investigating Tozorakimab Injections for COPD Patients

A Phase II, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils (COMETA)

Phase 2 Interventional AstraZeneca · NCT06897748

This study is testing if tozorakimab injections can help adults with COPD feel better and have fewer flare-ups compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment98 (estimated)
Ages40 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionstozorakimab
Locations9 sites (Izhevsk and 8 other locations)
Trial IDNCT06897748 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of tozorakimab injections compared to a placebo in adults with symptomatic chronic obstructive pulmonary disease (COPD) who have a history of exacerbations and elevated eosinophil levels. Participants will undergo a 12-week treatment period with bi-weekly injections and will be monitored for lung function, exacerbation rates, and safety outcomes. The study includes a screening phase of up to 5 weeks and a follow-up period of 10 weeks after treatment completion, totaling a maximum of 27 weeks. The primary focus is on improving symptoms and reducing exacerbations in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a documented diagnosis of COPD, a history of exacerbations, and elevated eosinophil counts.

Not a fit: Patients with clinically important pulmonary diseases other than COPD or significant radiological findings suggestive of other respiratory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and reduce exacerbations in patients with COPD.

How similar studies have performed: Other studies have shown promise with similar biologic approaches in treating COPD, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.
8. All participants must have eosinophil blood count ≥ 150 cells/µL.

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. Significant COVID-19 illness within the 6 months prior to enrolment.
8. Unstable cardiovascular disorder.
9. Diagnosis of clinically significant cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
10. 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.
11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C).
13. Evidence of active liver disease, including jaundice during screening.
14. 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.
15. Participants who, in the opinion of the Investigator or qualified designee, have evidence 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 change smoking 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 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.

Where this trial is running

Izhevsk and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseCOPDtozorakimabMEDI3506ICSLABA/LAMABiologicBiologic Treatment
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.