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Study of Tozorakimab effectiveness and safety in former smokers with Chronic Obstructive Pulmonary Disease (COPD) who experience disease flare-ups

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on evaluating a new treatment for people with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties. The study will test a medication called tozorakimab (also known as MEDI3506), which will be given as an injection under the skin, alongside standard COPD treatments including salbutamol, a medication that helps open up the airways.

The purpose of this research is to determine if tozorakimab can reduce the frequency of COPD flare-ups (also called exacerbations) when added to regular COPD treatments. During the study, some participants will receive tozorakimab while others will receive a placebo, in addition to their regular COPD medications. The study will particularly focus on people who previously smoked and have experienced COPD flare-ups in the past.

The treatment period will last for approximately one year, during which participants will receive regular injections of either tozorakimab or placebo. Throughout the study, participants will continue using their regular COPD medications, including inhalers. The study will monitor how often participants experience COPD flare-ups and track changes in their breathing and overall health.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and qualification

    If you are 40 years or older and have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) for at least one year, you may qualify for participation.

    Your medical history must show at least 2 moderate or 1 severe COPD flare-ups in the past 12 months.

    You must have been using prescribed inhaled medications (dual or triple therapy) for at least 3 months.

    Your smoking history must be 10 pack-years or more.

    Your CAT score (a measure of COPD symptoms) must be 10 or higher, with specific scores for cough and phlegm symptoms.

  2. Step 2

    Treatment phase

    You will receive either tozorakimab or a placebo (inactive substance) through subcutaneous injection (under the skin).

    You will continue using your regular COPD medications, including salbutamol inhaler as needed.

    The study will continue until August 31, 2026.

  3. Step 3

    Monitoring and assessments

    Your lung function will be regularly measured (FEV1 - the amount of air you can forcefully exhale).

    Your COPD symptoms and quality of life will be assessed using standardized questionnaires.

    The frequency and severity of COPD flare-ups will be tracked.

    Your use of rescue medication (salbutamol) will be monitored.

    Blood samples will be taken to measure medication levels and check for antibodies.

    Any side effects or health issues will be recorded throughout the study.

Who can join the trial?

7 criteria

  • Age 40 years or older and able to provide informed consent
  • Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least one year before joining the study
  • Must have specific lung function test results: - A ratio of FEV1/FVC less than 0.70 (This measures how much air you can exhale) - FEV1 greater than 20% of what would be normal for your age and height
  • History of either: - At least 2 moderate COPD flare-ups or - At least 1 severe COPD flare-up in the past 12 months
  • Must be using prescribed inhaled medications (either two or three different types) for at least 3 months before joining
  • Must have a smoking history of 10 pack-years or more (For example: smoking 1 pack per day for 10 years, or 2 packs per day for 5 years)
  • Must score 10 or higher on the CAT assessment (a questionnaire that measures COPD symptoms), with scores of at least 2 for both cough and phlegm symptoms

Who cannot join the trial?

15 criteria

  • Current smokers or those who quit smoking less than 12 months ago
  • Individuals with a known allergy or sensitivity to tozorakimab or similar medications
  • People with severe respiratory infections within the past 6 weeks
  • Those with active tuberculosis (a serious bacterial lung infection)
  • Patients with poorly controlled asthma (a condition causing breathing difficulties)
  • People with significant heart problems or unstable heart disease
  • Individuals participating in other clinical trials
  • Those with a history of cancer in the past 5 years (except successfully treated skin cancer)
  • Pregnant or breastfeeding women
  • People with severe liver disease
  • Individuals with compromised immune systems
  • Those who have received live vaccines within the past 30 days
  • People with uncontrolled diabetes (high blood sugar levels)
  • Individuals with severe kidney problems
  • Those unable to perform breathing tests properly
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Investigated drugs

Tozorakimab is a new investigational medication being studied for treating Chronic Obstructive Pulmonary Disease (COPD). It is designed to be used alongside standard COPD treatments to help reduce the frequency of disease flare-ups (exacerbations) in people who used to smoke. The medication is being tested to see if it can help patients who continue to experience COPD symptoms and flare-ups despite their regular treatments. Standard COPD care typically includes medications like inhalers and other treatments that help manage breathing difficulties and reduce inflammation in the airways. In this study, patients will receive either tozorakimab or a placebo in addition to their usual COPD medications.

What is already known about the treatment

Tozorakimab - An investigational medication being studied in Phase III clinical trials for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being tested as an add-on therapy to standard COPD treatments, specifically targeting patients who are former smokers and experience disease exacerbations. The medication is being evaluated through a double-blind, placebo-controlled study to determine its effectiveness in reducing the frequency of moderate to severe COPD flare-ups. While the exact mechanism of action is still under investigation through clinical trials, the drug is being developed as a novel therapeutic approach for managing COPD symptoms and preventing disease worsening.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) - A progressive lung condition that makes breathing difficult due to narrowed airways and damaged lung tissue. The disease typically develops over many years, primarily caused by long-term exposure to irritating gases or particles, most commonly from cigarette smoke. COPD causes symptoms such as shortness of breath, wheezing, chronic cough with mucus production, and chest tightness. The condition leads to increasingly limited airflow in and out of the lungs, making everyday activities more challenging over time. The disease can also cause frequent respiratory infections and periodic worsening of symptoms called exacerbations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505543-39-00Protocol codeD9180C00012Estimated enrolment1 190 patientsSponsorAstraZeneca AB

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