A Phase 2a, open-label, two-part study to evaluate the mechanism of action of itepekimab (anti-IL-33 mAb) on airway inflammation in patients with chronic obstructive pulmonary disease (COPD)
This study is investigating a new medicine called itepekimab, which is designed to calm inflammation in the airways, for people currently smoking who have Chronic Obstructive Pulmonary Disease (COPD). The main goal is to understand exactly how this medicine works inside the body. Researchers will be looking at changes in inflammation markers found in small samples taken from the airways, including the nose and lungs, before and after treatment with itepekimab. We also want to check for any side effects and how much of the medicine is in the blood. This early-stage research is important to see if itepekimab could be a safe and effective future treatment option for COPD.
At a glance
What is this study about?
This research study is looking into an experimental medicine called itepekimab for people who have a lung condition called Chronic Obstructive Pulmonary Disease (COPD) and who currently smoke. COPD makes it hard to breathe because the airways in the lungs are inflamed and narrowed. Itepekimab is designed to target and block a specific substance in the body called IL-33, which is thought to play a role in this inflammation.
The main aim of this study is to understand *how* itepekimab works in the airways of people with COPD. Researchers will be taking small samples from different parts of the airways – from inside the nose and from the larger breathing tubes in the lungs (bronchial biopsies and brushings). They will then look at these samples to see how the medicine might be changing the inflammation markers. This helps us learn more about the medicine's effects at a very detailed level.
By carefully observing these changes, as well as tracking any side effects and how much of the medicine is in the body, the researchers hope to gather important information. This information will help them decide if itepekimab shows promise as a new treatment that could reduce inflammation and potentially help people with COPD breathe easier in the future.
Key takeaways
- This study is testing a new medicine called itepekimab for COPD in current smokers.
- The main goal is to understand how the medicine affects inflammation in the airways.
- It involves taking small samples from the nose and lungs to check for changes.
- Participation includes receiving the study medicine and undergoing various health checks.
- It is an 'open-label' study, meaning everyone knows they are getting the active drug.
- This is an early-stage study to gather information for future potential treatments.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older, who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and currently smoke cigarettes.
Both men and women can take part in this research.
There will be other conditions that determine if someone can join the study, for instance, based on their medical history, current health, and other medications they may be taking. These will be checked by the study team during a screening visit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)?
- Do you currently smoke cigarettes?
- Are you willing to attend regular clinic visits for assessments?
- Are you comfortable with the idea of having small samples taken from your airways (like nasal swabbing and lung biopsies)?
What does participation involve?
If you decide to take part, you would receive the experimental medicine, itepekimab. The study involves several visits to the clinic over a period of time. During these visits, you would have various assessments, which might include blood tests, checks of your vital signs (like blood pressure and heart rate), and tests to check your lung function. Importantly, the study will involve taking small samples from your airways, like nasal brushings (a gentle swab inside your nose) and bronchial samples (small biopsies and brushings from inside your breathing tubes in the lungs). These procedures help the researchers understand how the medicine is working. You would be carefully monitored throughout the study for your safety and well-being. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedDenmark
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a lung condition that makes it hard to breathe due to inflammation and damage in the airways.
What is itepekimab?
Itepekimab is an experimental medicine being tested in this study. It's designed to target a specific substance in the body that causes inflammation in the airways.
Will I receive treatment for my COPD if I join?
You will receive the experimental medicine, itepekimab. This is a research study to see how the medicine works, rather than a standard treatment for your condition at this stage.
What is an 'open-label' study?
An 'open-label' study means that both you and the study team will know that you are receiving the active medicine (itepekimab) and not a placebo (a dummy treatment).
Who is funding this study?
The information provided doesn't specify the exact funder, but clinical trials are typically sponsored by pharmaceutical companies or research institutions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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