Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled, parallel-group, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

This study is looking into a new medicine called itepekimab for adults living with bronchiectasis. Bronchiectasis is a long-term lung condition. The main goal is to find out if itepekimab can help reduce how often people have flare-ups (called 'pulmonary exacerbations') of their condition, and to check for any side effects. Participants will be randomly given either the new medicine or a 'dummy' medicine (placebo), without knowing which they receive. Researchers will then compare the groups to see if itepekimab makes a difference to their lung health, including how often they get infections and their quality of life. This is an early-stage study, meaning we're still learning a lot about this new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

138

Start

29 May 2024

Bronchiectasis

What is this study about?

This study is designed to explore a new treatment called itepekimab for a lung condition called bronchiectasis. Bronchiectasis is a long-term illness where your airways become stretched and scarred, making them wider than usual. This can lead to mucus building up, chest infections, and flare-ups where your symptoms get worse. Researchers want to see if itepekimab can help reduce these flare-ups and improve people's overall lung health. Because it's a new medicine, they also want to carefully check for any side effects.

To make sure the results are fair and accurate, this study will compare itepekimab to a 'dummy' medicine, called a placebo. This means that some participants will receive the actual medicine, and others will receive a substance that looks exactly like the medicine but has no active ingredients. Neither the participants nor their doctors will know who is getting which treatment. This helps to ensure that any improvements or side effects observed are truly due to the medicine and not other factors.

The study will mainly focus on how many flare-ups participants have during the treatment period. They will also look at other important things, like how long it takes until someone has their first flare-up, how many people manage to avoid flare-ups completely, and how the medicine affects lung function (how well your lungs work) and daily life. They'll also be closely monitoring for any unwanted reactions or side effects.

Key takeaways

This study is testing a new medicine (itepekimab) for bronchiectasis.
It aims to reduce flare-ups and check for safety.
Participants will receive either the new medicine or a dummy medicine (placebo).
Neither you nor your doctor will know which treatment you are getting.
The study is for adults aged 18 and older with non-cystic fibrosis bronchiectasis.
Close monitoring of your health and lung function will be part of the study.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women can take part. The study is specifically for people who have been diagnosed with bronchiectasis, but it's important that your bronchiectasis is not caused by cystic fibrosis.

The doctors running the study will check other medical details to make sure the treatment is suitable for you and that you can safely take part. This will involve reviewing your medical history and maybe doing some tests to confirm you meet all the necessary requirements for the study.

Even if you have bronchiectasis and are over 18, there might be other specific health conditions or medications that would prevent you from joining. The study team will discuss all these details with you.

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?
Have you been diagnosed with bronchiectasis?
Is your bronchiectasis NOT caused by cystic fibrosis?
Are you able to attend regular clinic visits?
Are you willing to have medical tests like blood draws and lung function checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine (itepekimab) or a placebo, which looks identical but contains no active ingredients. It's a 'blinded' study, meaning neither you nor your study doctor will know which one you're receiving. You would have regular visits to the clinic for medical check-ups, tests, and to receive your treatment. These visits will involve health assessments, such as checking your lung function, blood tests, and discussing any symptoms or side effects you might be experiencing. You would also be asked about your quality of life. The study will carefully monitor for any flare-ups of your bronchiectasis and note if you need antibiotics. The total duration of your participation in the study, including treatment and follow-up, would be made clear by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new medicine that could help manage your bronchiectasis, or at least having closer medical monitoring. However, there's no guarantee you'll receive the active drug or that itepekimab will work for you. There are also potential risks involved, as with any new medicine. You might experience side effects, some of which could be serious, or the treatment may not be effective. The study team will fully explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Czechia
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Unverified
Spain
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Unverified
Denmark
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Unverified
Netherlands
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Unverified
France
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Unverified
Greece
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Unverified
Poland
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Unverified
Germany

Common questions

What is itepekimab?

Itepekimab is a new investigational medicine being tested to see if it can help people with bronchiectasis.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real thing but doesn't contain any active drug. It helps researchers compare the effects of the new medicine accurately.

What are 'flare-ups' of bronchiectasis?

Flare-ups, also called 'pulmonary exacerbations,' are times when your bronchiectasis symptoms get worse, often needing treatment with antibiotics.

Will I know if I'm getting the real medicine?

No, this is a 'blinded' study, meaning neither you nor your doctor will know whether you're receiving itepekimab or the placebo until the study ends.

Why is this study important?

This study aims to find out if itepekimab can be a safe and effective new treatment option to help people with bronchiectasis manage their condition better.