Chronic Obstructive Pulmonary Disease (COPD)Phase 2COMETANCT06897748
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
A Phase 2 study testing Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 12 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tozorakimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 12 sitesRussia
- Study dates
- 12 Apr 2025to 21 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 40 years of age and capable of giving signed informed consent.
- Documented diagnosis of COPD for at least one year prior to enrolment.
- Post-BD FEV1/FVC < 0.70 and post-BD FEV1 >20% and < 80% of predicted normal value.
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
- Smoking history of ≥ 10 pack-years.
- CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2.
- All participants must have eosinophil blood count ≥ 150 cells/µL.
Who cannot join
- Clinically important pulmonary disease other than COPD.
- 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.
- 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.
- 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.
- COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
- 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.
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- Significant COVID-19 illness within the 6 months prior to enrolment.
- Unstable cardiovascular disorder.
- Diagnosis of clinically significant cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
- 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.
- History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
- History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C).
- Evidence of active liver disease, including jaundice during screening.
- 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.
- Participants who, in the opinion of the Investigator or qualified designee, have evidence of active TB.
- History of partial or total lung resection.
- Scheduled major surgical procedure during the course of the study.
- Participants that have previously received tozorakimab.
- Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Research Site
Aramil, 624002
Research Site
Izhevsk, 426061
Research Site
Moscow, 105554
Research Site
Moscow, 117546
Research Site
Moscow, 119048
Research Site
Moscow, 125284
Research Site
Omsk, 644099
Research Site
Penza, 440067
Research Site
Perm, 614000
Research Site
Saint Petersburg, 193231
Research Site
Saratov, 410054
Research Site
Ulyanovsk, 432009
About this study
Official title: 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)
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.
- Being tested
- Placebo, Tozorakimab
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, MEDI3506, ICS, LABA/LAMA, Biologic, Biologic Treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study
TozorakimabDrug
Administered subcutaneously tozorakimab and placebo throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Tozorakimab | Experimental | Dosing subcutaneously tozorakimab Receives: Drug: Tozorakimab |
| Placebo | Placebo comparator | Dosing subcutaneously with equivalent volume to tozorakimab Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
The difference in mean change from baseline in FEV1
Measured: Baseline through Week 12
Secondary outcomes (9)
Annualized rate of composite endpoint for exacerbations in COPD (COPDCompEx) events
The rate ratio of COPDCopmEx events
Measured: From baseline to Week 12
Change from baseline in post-BD FEV1
The difference in mean change from baseline in post-BD FEV1
Measured: From baseline through Week 12
Change from baseline in pre-BD and post-BD forced vital capacity (FVC)
The difference in mean change from baseline in pre-BD and post-BD FVC
Measured: From baseline through Week 12
FEV1 % reversibility dynamics
The difference in mean change from baseline in FEV1 % reversibility
Measured: From baseline to Week 12
Change from baseline in peak expiratory flow (PEF) measured in clinic and at home
The difference in mean change from baseline in PEF
Measured: From baseline through Week 12
Change from baseline in home FEV1
The difference in mean change from baseline in FEV1
Measured: From baseline through Week 12
Time to first COPDCompEx event
The hazard ratio for COPDCompEx event occurrence
Measured: From baseline to Week 12
Change from baseline in mean Breathless, cough and sputum scale (BCSS) score
The difference in mean change from baseline in BCSS.
The BCSS, is a 3-item daily Diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough; each on a 5-point scale (from 0 to 4). Higher scores for each domain, and thus for total score, indicate more severe symptoms.
Measured: From baseline to Week 12
Change from baseline in COPD assessment test (CAT) total score
The difference in mean change from baseline in CAT.
The CAT consists of eight questions that ask the participant to rate items relating to symptoms and impact on quality of life (such as normal activity and sleep). Each question is performed on a scale from 0 to 5 with 0 being the best possible health status or least impairment and 5 being the worst health status or greatest impairment.
Measured: From baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start12 Apr 2025
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897748
- Sponsor's protocol ID
- AZ-RU-00008
- Acronym
- COMETA
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06897748
- Acronym / sponsor ID
- COMETA / AZ-RU-00008
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, MEDI3506, ICS, LABA/LAMA, Biologic, Biologic Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tozorakimab | Experimental | Drug: TozorakimabDosing subcutaneously tozorakimab |
| Placebo | Placebo comparator | Drug: PlaceboDosing subcutaneously with equivalent volume to tozorakimab |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must be ≥ 40 years of age and capable of giving signed informed consent.
- Documented diagnosis of COPD for at least one year prior to enrolment.
- Post-BD FEV1/FVC < 0.70 and post-BD FEV1 >20% and < 80% of predicted normal value.
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
Key exclusion criteria (20 listed)
- Clinically important pulmonary disease other than COPD.
- 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.
- 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.
- 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.
- COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo administered subcutaneously, equivalent volume to tozorakimab throughout the study | Drug | Placebo |
| TozorakimabAdministered subcutaneously tozorakimab and placebo throughout the study | Drug | Tozorakimab |
Primary outcome
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
Time frame: Baseline through Week 12
The difference in mean change from baseline in FEV1
9 secondary outcomes
Annualized rate of composite endpoint for exacerbations in COPD (COPDCompEx) events
Time frame: From baseline to Week 12
Change from baseline in post-BD FEV1
Time frame: From baseline through Week 12
Change from baseline in pre-BD and post-BD forced vital capacity (FVC)
Time frame: From baseline through Week 12
FEV1 % reversibility dynamics
Time frame: From baseline to Week 12
Change from baseline in peak expiratory flow (PEF) measured in clinic and at home
Time frame: From baseline through Week 12
Change from baseline in home FEV1
Time frame: From baseline through Week 12
Time to first COPDCompEx event
Time frame: From baseline to Week 12
Change from baseline in mean Breathless, cough and sputum scale (BCSS) score
Time frame: From baseline to Week 12
Change from baseline in COPD assessment test (CAT) total score
Time frame: From baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic (time frame: Baseline through Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.