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

NCT06897748 | Active Not Recruiting Phase 2

• 1 other identifier: AZ-RU-00008
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 12

Brief 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

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Week 12

Secondary Outcomes (9)

• Annualized rate of composite endpoint for exacerbations in COPD (COPDCompEx) events

  From baseline to Week 12

• Change from baseline in post-BD FEV1

  From baseline through Week 12

• Change from baseline in pre-BD and post-BD forced vital capacity (FVC)

  From baseline through Week 12

• FEV1 % reversibility dynamics

  From baseline to Week 12

• Change from baseline in peak expiratory flow (PEF) measured in clinic and at home

  From baseline through Week 12

Other Outcomes (1)

• Number of patients with adverse events (AEs)

  Through study completion, up to 27 weeks

Study Arms (2)

Tozorakimab

EXPERIMENTAL

Dosing subcutaneously tozorakimab

Drug: Tozorakimab

Placebo

PLACEBO COMPARATOR

Dosing subcutaneously with equivalent volume to tozorakimab

Drug: Placebo

Interventions

Tozorakimab DRUG

Administered subcutaneously tozorakimab and placebo throughout the study

Tozorakimab

Placebo DRUG

Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Aramil, 624002, Russia

Location

Research Site

Izhevsk, 426061, Russia

Location

Research Site

Moscow, 105554, Russia

Location

Research Site

Moscow, 117546, Russia

Location

Research Site

Moscow, 119048, Russia

Location

Research Site

Moscow, 125284, Russia

Location

Research Site

Omsk, 644099, Russia

Location

Research Site

Penza, 440067, Russia

Location

Research Site

Perm, 614000, Russia

Location

Research Site

Saint Petersburg, 193231, Russia

Location

Research Site

Saratov, 410054, Russia

Location

Research Site

Ulyanovsk, 432009, Russia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: April 12, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at : https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (12)