CompletedNCT06897748COMETAUpdated Jul 14, 2026

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 interventional study of Placebo and Tozorakimab in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 12 sites in Russia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 98
Allocation: Randomized
Ages: 40 Years and older
Sex: All

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.

Conditions studied

Chronic Obstructive Pulmonary Disease (COPD)

Browse trials for

Pulmonary Disease, Chronic Obstructive 4,131

Keywords

Chronic Obstructive Pulmonary Disease
COPD
tozorakimab
MEDI3506
ICS
LABA/LAMA
Biologic
Biologic Treatment

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 98 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 98 participants (actual)

Study arms

Experimental
Tozorakimab
Dosing subcutaneously tozorakimab
Drug: Tozorakimab
Placebo comparator
Placebo
Dosing subcutaneously with equivalent volume to tozorakimab
Drug: Placebo

Interventions

DrugPlacebo
Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study
DrugTozorakimab
Administered subcutaneously tozorakimab and placebo throughout the study

What researchers measure

Primary outcomes

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
Time frame: Baseline through Week 12

Secondary outcomes

Annualized rate of composite endpoint for exacerbations in COPD (COPDCompEx) events
The rate ratio of COPDCopmEx events
Time frame: From baseline to Week 12
Change from baseline in post-BD FEV1
The difference in mean 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)
The difference in mean change from baseline in pre-BD and post-BD FVC
Time frame: From baseline through Week 12
FEV1 % reversibility dynamics
The difference in mean change from baseline in FEV1 % reversibility
Time frame: 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
Time frame: From baseline through Week 12
Change from baseline in home FEV1
The difference in mean change from baseline in FEV1
Time frame: From baseline through Week 12
Time to first COPDCompEx event
The hazard ratio for COPDCompEx event occurrence
Time frame: 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.
Time frame: 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.
Time frame: From baseline to Week 12

Other outcomes

Number of patients with adverse events (AEs)
The measure of interest is frequencies and percentages of participants with reported AEs.
Time frame: Through study completion, up to 27 weeks

Study locations

12 sites

Research Site
Aramil, 624002, Russia
Research Site
Izhevsk, 426061, Russia
Research Site
Moscow, 105554, Russia
Research Site
Moscow, 117546, Russia
Research Site
Moscow, 119048, Russia
Research Site
Moscow, 125284, Russia
Research Site
Omsk, 644099, Russia
Research Site
Penza, 440067, Russia
Research Site
Perm, 614000, Russia
Research Site
Saint Petersburg, 193231, Russia
Research Site
Saratov, 410054, Russia
Research Site
Ulyanovsk, 432009, Russia

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06897748
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Mar 27, 2025
Start date: Apr 12, 2025
Primary completion: Apr 21, 2026
Completion: Apr 21, 2026
Last update: Jul 14, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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