This study is looking at Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes it hard to breathe and can cause flare-ups called exacerbations. The study involves people who have this lung disease and have experienced these flare-ups in the past. Participants will receive either tozorakimab, which is an investigational medication given as an injection under the skin, or placebo. All participants will continue taking their regular lung medications, including salbutamol, which is a quick-relief inhaler that helps open the airways when needed.
The purpose of this study is to evaluate the long-term effect of tozorakimab in reducing severe flare-ups of the lung disease in people who used to smoke. The study will also look at how safe the medication is when used over a longer period of time. This is an extension study, which means it is designed for people who have already participated in earlier studies of the same medication and completed their treatment without stopping early.
Participants who join this study will continue receiving the same type of treatment they were on in the previous study for up to 52 weeks. They will attend regular clinic visits where doctors will check their lung function, ask about any breathing problems or flare-ups, and monitor for any side effects. The study will track how often participants experience severe flare-ups that require emergency room visits or hospital stays, and will measure how long it takes before these serious episodes occur. Blood samples may be collected to measure the amount of medication in the body and to check how the immune system responds to the treatment.
1Transition from previous study
This study is a continuation for participants who have already completed the treatment period in a previous study called OBERON or TITANIA.
To enter this extension study, the last dose of medication from the previous study must have been received within the past 12 weeks.
Participation in this study is only possible if treatment in the previous study was completed without early discontinuation of the study medication.
2Initial visit and screening procedures
At the first visit, informed consent will be signed, confirming voluntary participation in the study.
If applicable, a urine pregnancy test will be performed, which must be negative to continue in the study.
Confirmation will be required that the same contraceptive methods agreed upon in the previous study will continue to be used throughout this study.
3Treatment period with study medication
The study medication will be either tozorakimab or placebo, assigned randomly. The placebo is an inactive substance that looks identical to the actual medication.
Tozorakimab or placebo will be administered as an injection under the skin (subcutaneous injection).
The study medication will be given in addition to the regular medications for chronic obstructive pulmonary disease, which is a long-term lung condition that makes breathing difficult.
Treatment will continue for an extended period as part of this long-term study, which is expected to run until February 2026.
Throughout the treatment period, regular visits will be scheduled to monitor health status and any changes in the condition.
4Use of rescue medication
Salbutamol will be available as a rescue medication if needed. This medication is inhaled and helps to quickly relieve breathing difficulties.
Salbutamol is used when symptoms suddenly worsen or when quick relief is needed.
5Monitoring and assessments during the study
Regular assessments will be conducted to evaluate how well the study medication is working and to monitor for any side effects.
The study will track the number and severity of exacerbations, which are sudden worsening episodes of lung disease symptoms such as increased coughing, shortness of breath, or mucus production.
Particular attention will be paid to severe exacerbations, which are episodes that require hospitalization or emergency room visits.
Blood samples may be taken periodically to measure the levels of study medication in the body and to check if the body has developed any immune response to the medication.
Safety monitoring will continue throughout the entire study period to assess the long-term tolerability of the treatment.
6Completion of the study
The study will continue until the planned end date or until the study physician determines that participation should end.
A final assessment will be conducted to evaluate the overall response to treatment and any long-term effects.
Information collected during the study will be used to determine whether the study medication is effective in reducing severe lung disease episodes over the long term.
Who Can Join the Study?
You must have completed the full treatment period in the previous OBERON or TITANIA studies without stopping the study medicine early
You must have received your last dose of study medicine in the previous studies within the past 12 weeks, which means within the last three months
You must not have withdrawn or dropped out from the previous study
If you are a woman who is able to become pregnant, you must have a negative urine pregnancy test, which is a test that checks if you are pregnant using a urine sample, at your first visit
You must be willing to continue using the same birth control methods that you agreed to use in the previous OBERON or TITANIA studies to prevent pregnancy
You must be able to understand the study information and sign a document showing you agree to take part in the study, which is called informed consent
Who Cannot Join the Study?
The source data does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list specific medical conditions, medications, or situations that would prevent participation
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details are not provided in the available information
Tozorakimab is an investigational medication being studied as an add-on treatment for people with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. Exacerbations are periods when COPD symptoms suddenly get worse. This medication is given in addition to standard care treatments to see if it can help reduce the number of severe flare-ups in people who used to smoke.
A placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against tozorakimab to help researchers determine if the actual medication is effective.
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, which blocks airflow and makes it hard to get air in and out. People with this disease often experience coughing, wheezing, shortness of breath, and chest tightness. The condition usually develops slowly over many years, most commonly in people who smoke or have smoked. As the disease progresses, everyday activities like walking or climbing stairs become increasingly difficult due to breathing problems. The lungs continue to deteriorate over time, leading to more frequent episodes called exacerbations where symptoms suddenly worsen.
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