AuthorisedTherapeutic confirmatory (Phase III)Interventional

A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies

This study is a continuation for adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and previously took part in earlier trials (EFC18418 or EFC18419). It's focused on understanding the long-term safety of a medicine called itepekimab. Researchers want to see if there are any side effects or problems over a longer period. They will also look at how well the medicine continues to reduce nasal polyps and other sinus symptoms, and if people need fewer steroids or surgeries. This will help doctors understand if itepekimab is a safe and effective long-term treatment for this condition.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

146

Start

11 May 2026

Chronic rhinosinusitis with nasal polyps

What is this study about?

This research study is looking at a new medication called itepekimab. It's specifically for adults who have a condition called chronic rhinosinusitis with nasal polyps (often shortened to CRSwNP). This means they have ongoing inflammation in their nose and sinuses, along with growths called nasal polyps inside their nose.

This particular study is a "long-term extension" study. This means it's for people who have already taken part in earlier studies of itepekimab (called EFC18418 or EFC18419). The main goal is to check how safe itepekimab is when used for a longer time. Researchers want to keep a close eye on any side effects that might appear over many months or even years. They'll also be looking to see if the medicine continues to help with symptoms like blocked nose and taste/smell problems, and if it reduces the need for other treatments like steroid medicines or surgery for polyps.

The information gathered from this study is really important. It helps doctors and health authorities understand if itepekimab is a good choice for long-term treatment of CRSwNP. This kind of research is crucial to make sure new medicines are both effective and safe for people to use in the long run.

Key takeaways

This study focuses on the long-term safety of a new medicine, itepekimab.
It's only for adults who have already participated in specific earlier itepekimab studies.
Researchers will monitor side effects and how well the treatment controls nasal polyps and sinus symptoms over time.
Information from this study helps us understand the long-term effects of itepekimab.
You will receive regular medical check-ups and monitoring if you join.

Who may be eligible?

To be able to join this study, you must be an adult, aged 18 or over. This study is for both men and women.

Crucially, you must have successfully completed one of the two previous studies of itepekimab, either EFC18418 or EFC18419. If you weren't in one of those specific studies, you won't be able to join this one.

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 chronic rhinosinusitis with nasal polyps (CRSwNP)?
Did you complete either the EFC18418 or EFC18419 study?
Are you comfortable with regular clinic visits and blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive either the study medicine, itepekimab, or a placebo (a dummy medicine that looks the same) as you did in the previous study. You will have regular visits to the study clinic where the medical team will check on your health, ask about any side effects, and perform examinations to see how your nasal polyps are doing. They will also take blood samples to measure the drug levels and check for any body responses to the medicine. The total duration of your participation will depend on the study design, but generally, long-term extension studies involve regular follow-up over an extended period, potentially several years, to monitor safety and effectiveness.

Potential risks and benefits

Taking part in this study means you'll be closely monitored by a medical team, which could be beneficial for your health. You might also continue to experience the positive effects of itepekimab if you are receiving the active drug. However, as with any medication, there's a chance you could experience side effects, some of which might be serious. The researchers will be carefully looking for these. Remember, joining any study is voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (15)

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

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Unverified
Germany
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Unverified
Netherlands
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Unverified
Portugal
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Unverified
Denmark
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Unverified
Sweden
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Unverified
Finland
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Unverified
France
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Unverified
Spain
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Unverified
Austria
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Unverified
Italy
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Unverified
Hungary
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Unverified
Romania

Common questions

What is chronic rhinosinusitis with nasal polyps (CRSwNP)?

It's a long-lasting condition where you have swelling and inflammation in your nose and sinuses, along with soft, non-cancerous growths called nasal polyps.

What is itepekimab?

Itepekimab is a new investigational medicine being tested for treating CRSwNP. We are studying its long-term safety and how well it works.

Why is this study only for people who were in previous studies?

This is an extension study, meaning it follows on from earlier trials (EFC18418 or EFC18419). It allows researchers to gather more safety information over a longer period for those who have already started the treatment.

What is a 'double-blinded' study?

It means neither you nor the study doctors will know whether you are receiving the active medicine (itepekimab) or the placebo (dummy medicine).

Will I still get my usual treatment for CRSwNP?

The study team will discuss this with you, as participation might affect what other treatments you can or cannot take during the study.