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Long-term Safety Study of Tozorakimab for Patients with Chronic Obstructive Pulmonary Disease and History of Exacerbations

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is studying a medication called tozorakimab in people who have Chronic Obstructive Pulmonary Disease, also known as COPD. COPD is a long-term lung condition that makes it difficult to breathe and can cause episodes called exacerbations, which are sudden worsening of symptoms. This study is specifically for people with COPD who have had these worsening episodes in the past. Tozorakimab is given as an injection under the skin and will be used together with the usual medications that people are already taking for their COPD.

The purpose of this study is to look at the long-term safety and how well people tolerate tozorakimab when it is added to their standard care. This is an extension study, which means it is designed for people who have already participated in earlier studies of this medication. The study will continue to give tozorakimab to participants to see if it remains safe over a longer period of time. The medication will be given regularly over a period that can last up to 36 months.

During the study, participants will receive tozorakimab and will be monitored for any side effects or health changes. The study team will collect information about any adverse events that occur, perform laboratory tests, and track how participants are doing overall. This information will help researchers understand whether tozorakimab is safe for long-term use in people with COPD who have experienced exacerbations.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Entry into the extension study

    This study is an extension of previous studies called TITANIA, MIRANDA, or PROSPERO. You will be eligible to enter this extension study if you have completed the treatment period and follow-up in one of these previous studies without stopping the study medication early.

    Before starting, you will need to provide signed informed consent, confirming that you agree to participate in this extension study.

    You will need to continue using the same contraceptive methods that were agreed upon in the previous study.

  2. Step 2

    Treatment period with tozorakimab

    You will receive tozorakimab, which is a solution for injection. The medication will be given as an injection under the skin (subcutaneous injection).

    This medication will be added to your current standard treatment for chronic obstructive pulmonary disease (COPD), which is a long-term lung condition that makes breathing difficult.

    The study is designed to evaluate the long-term safety of this medication. The specific dosage, frequency, and duration of treatment are not detailed in the available information, but you will receive regular doses over an extended period.

    The treatment period will continue for a long duration as this is a long-term safety study.

  3. Step 3

    Safety monitoring visits

    Throughout the study, you will attend regular visits where your health will be monitored.

    During these visits, laboratory tests will be performed to check various health markers in your blood and other samples.

    The medical team will monitor you for any adverse events, which are any unwanted or harmful effects that may occur during the study. This includes checking how often they occur, how severe they are, and whether they might be related to the study medication.

    Any significant health changes, serious adverse events, or events that might lead to stopping the medication will be carefully recorded and assessed.

  4. Step 4

    Ongoing assessment

    The study will assess the long-term safety and tolerability of tozorakimab, meaning how well you can take the medication over an extended period without experiencing unacceptable side effects.

    Your participation in this extension study is expected to continue until the estimated study completion date in December 2028, though your individual participation duration may vary.

Who can join the trial?

4 criteria

  • You must have previously participated in one of the earlier studies called TITANIA, MIRANDA, or PROSPERO and completed the treatment period and follow-up without stopping the study medicine early, or in the case of PROSPERO, you may have continued receiving the study medicine until a specific reporting point and attended a visit 12 weeks after your last dose
  • You must be enrolled in the French Social Security system, which is the healthcare system in France
  • You must be willing to continue using contraceptive methods, which are ways to prevent pregnancy, as you agreed to use in the previous study
  • You must be able to understand and sign an informed consent form, which is a document that explains the study and confirms you agree to participate

Who cannot join the trial?

5 criteria

  • The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
  • Without detailed information about who cannot join this study, it is not possible to list the specific conditions or situations that would prevent participation
  • Generally, exclusion criteria may include things like other serious health conditions, certain medications being taken, pregnancy or breastfeeding, recent participation in other studies, or specific test results that fall outside acceptable ranges
  • The study involves tozorakimab, which is a medication being tested as an additional treatment for Chronic Obstructive Pulmonary Disease, a lung condition that makes breathing difficult
  • The research team would provide complete information about who cannot participate during the screening process
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Investigated drugs

Tozorakimab is an investigational medication being studied as an additional treatment for people with chronic obstructive pulmonary disease (COPD) who have experienced flare-ups of their condition. It is given on top of the regular medications that patients are already taking for their COPD. This study aims to evaluate how safe this medication is when used over a long period of time.

What is already known about the treatment

Tozorakimab – Tozorakimab is an investigational medication currently being studied in clinical trials for the treatment of Chronic Obstructive Pulmonary Disease (COPD), specifically in patients who experience frequent flare-ups of their condition. This medication is given as an add-on treatment to standard COPD therapies and works at the molecular level by targeting specific proteins involved in lung inflammation and airway narrowing. It is being evaluated in a Phase III extension study called ROMEO to assess its long-term safety and tolerability when used over extended periods in COPD patients with a history of exacerbations. As an investigational drug, tozorakimab is not yet approved for general medical use and is currently available only through participation in clinical research studies.

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes breathing difficult. The airways in the lungs become narrowed and damaged over time, which blocks the flow of air. This disease usually develops slowly over many years, often due to smoking or exposure to harmful substances. People with this condition experience symptoms such as shortness of breath, persistent cough, and frequent chest infections. The disease gradually worsens, causing the airways to become more inflamed and the lung tissue to lose its ability to stretch properly. As the condition progresses, everyday activities become increasingly difficult due to breathing problems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523690-41-00Protocol codeD9180C00015Estimated enrolment82 patientsSponsorAstraZeneca AB

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