Active not recruitingPHASE3INTERVENTIONAL

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

This study is testing a new medicine called Itepekimab for adults who have ongoing sinus problems and growths in their nose called nasal polyps, which haven't been properly controlled by their usual treatment. Researchers want to see if Itepekimab is effective at reducing symptoms, how safe it is, and if people can take it without too many side effects. Participants will receive either Itepekimab, a dummy medicine (placebo), or a standard nasal spray. The study will last up to 76 weeks, with treatment for up to 52 weeks, and involve a mix of clinic visits and phone check-ups.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

231

Start

12 Feb 2025

Estimated completion

16 Sep 2027

Chronic Rhinosinusitis With Nasal Polyps

What is this study about?

This study is for adults in the UK who have suffered from a long-term condition called chronic rhinosinusitis with nasal polyps. This means you have ongoing inflammation in your sinuses and growths in your nose called nasal polyps, which can cause symptoms like a blocked nose, reduced sense of smell, or a runny nose. The purpose of this study is to explore a new treatment called Itepekimab.

Researchers want to find out if Itepekimab can help improve symptoms, make people feel better, and reduce the polyps. They also want to understand if it's safe to use and whether people can tolerate it without serious side effects. To do this, some participants will receive the new medicine, others will get a 'dummy' medicine (placebo) – which looks exactly like the real medicine but contains no active ingredients – and some might get a standard nasal spray. This allows doctors to compare the effects of the new treatment directly.

This is a 'Phase 3' study, which means it’s one of the final stages of testing before a new medicine might become available to everyone. It's a large study, involving many people, designed to provide clear answers about the potential benefits and risks of Itepekimab for this specific condition.

Key takeaways

Tests a new medicine (Itepekimab) for long-term sinus problems and nasal polyps.
Compares Itepekimab to a dummy medicine or standard nasal spray.
Participation could last up to 76 weeks, with treatment for up to 52 weeks.
Involves clinic visits and phone check-ups.
Aims to check effectiveness, safety, and tolerability of the new medicine.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a history of chronic rhinosinusitis with nasal polyps for at least a year. Your nasal polyps should still be causing ongoing symptoms, like a blocked nose, and have a certain level of size when examined by a doctor. You also need to have tried certain treatments before, such as having had surgery for nasal polyps or needing steroid tablets for your sinus problems in the past year.

There are also some specific requirements about your symptoms: your nose must feel blocked or obstructed at a moderate or severe level when you first visit, and it must have been bothering you for at least 12 weeks. You also need to have either a reduced sense of smell or a runny nose.

If you are a woman who could become pregnant, you would need to agree to use effective birth control during the study and for 20 weeks after your last dose of the study medicine. Certain other serious health conditions, apart from asthma or aspirin sensitivity, might prevent you from joining, as they could affect the study results or your safety.

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 had chronic rhinosinusitis with nasal polyps for at least a year?
Do you currently have ongoing, bothersome nasal congestion/blockage?
Have you had nasal polyp surgery or needed steroid tablets for your sinuses in the last year?
If you are a woman capable of getting pregnant, would you use effective birth control during and after the study?

Answer every question to see your result.

What does participation involve?

If you join this study, it could last for up to 76 weeks, which is about a year and a half. This includes a short period of checking if you’re suitable (4 weeks), up to 52 weeks where you’ll be receiving the study medicine, and then a 20-week follow-up period to check on your health after treatment stops. Some people might have a slightly shorter study time if they move on to another related study.

Over this time, you will have 9 visits to the clinic or study site. You'll also have 20 check-ups over the phone or at your home. During these visits, doctors will monitor your health, check your symptoms, give you the study medicine, and look for any side effects. You'll be taking the treatment for up to 52 weeks.

Potential risks and benefits

Participating in a clinical trial may offer the potential benefit of accessing a new treatment before it's widely available, which might improve your symptoms or condition. However, there are also potential risks, as the effects of new medicines are still being studied. You might experience side effects, and the treatment may not work for you. All medical procedures and medications carry some risks. Your health will be carefully monitored throughout the study. You're always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (121)

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

University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037
Verified postcode
Arcadia, United States
Sensa Health- Site Number : 8400038
Verified postcode
Los Angeles, United States
Newport Native MD- Site Number : 8400031
Verified postcode
Newport Beach, United States
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064
Verified postcode
Roseville, United States
Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040
Verified postcode
Torrance, United States
Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035
Verified postcode
Torrance, United States
Advanced Research Associates (ARA) Professionals- Site Number : 8400011
Verified postcode
Miami, United States
Paradisus Med Research - Miami- Site Number : 8400009
Verified postcode
Miami, United States
Orlando ENT Associates - Orlando- Site Number : 8400008
Verified postcode
Orlando, United States
Emory University School of Medicine- Grady Campus- Site Number : 8400047
Verified postcode
Atlanta, United States
Treasure Valley Medical Research- Site Number : 8400063
Verified postcode
Boise, United States
University of Chicago Medical Center- Site Number : 8400018
Verified postcode
Chicago, United States

Common questions

What is Itepekimab?

Itepekimab is a new medicine being tested for long-term sinus problems with nasal polyps. It works by targeting a specific part of your immune system.

What are nasal polyps?

Nasal polyps are soft, painless, non-cancerous growths inside your nose or sinuses. They can cause a blocked nose, reduced sense of smell, and other difficulties.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real study medicine but doesn't contain any active ingredients. It helps researchers fairly compare the new medicine's effects.

How long will I take the study medicine?

You could be taking the study medicine for up to 52 weeks, which is almost a year.

Will I know if I'm getting the new medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know whether you are receiving Itepekimab, placebo, or the nasal spray until after the study is complete. This helps ensure fair results.