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 research study is looking at a new medicine called itepekimab, for adults who have ongoing sinus issues and growths in their nose called nasal polyps. These are people whose condition hasn't improved enough with typical treatments. The study aims to find out if itepekimab is effective at reducing symptoms and improving quality of life, and also to check if it's safe and well-tolerated. Participants will receive either the new drug, a placebo (dummy drug), or a standard nasal spray, alongside their usual nasal steroid spray. It's a large, international study where neither the patients nor the doctors will know who is getting which treatment until the very end, to make the results as fair as possible.
At a glance
What is this study about?
This study is about a health problem called chronic rhinosinusitis with nasal polyps, often shortened to CRSwNP. This is a long-lasting condition where the lining of your nose and sinuses (the air-filled spaces behind your cheekbones and forehead) become swollen and inflamed. This can lead to symptoms like a blocked nose, difficulty breathing through your nose, a reduced sense of smell, and a runny nose. Nasal polyps are soft, painless growths that can appear inside your nose or sinuses, making these symptoms worse.
For many people, standard treatments like nasal steroid sprays don't fully control their CRSwNP. This study is testing a new medicine called itepekimab. Researchers believe this new drug might help by targeting specific parts of the body's immune system that are involved in the inflammation and growth of nasal polyps. By understanding how this drug works, we hope to find a new and better way to manage this condition for people who haven't found enough relief from current options.
The main goal of this study is to see if itepekimab is effective at reducing the symptoms of CRSwNP and shrinking nasal polyps, and to find out if it's safe to use. We also want to understand if itepekimab can help improve overall quality of life for people living with this condition. The study will compare itepekimab against a placebo (a treatment that looks exactly like the study drug but contains no active medicine) and a standard nasal spray, to get a clear picture of its benefits and potential side effects.
Key takeaways
- This study tests a new drug for chronic sinus problems and nasal polyps.
- It aims to see if the new drug, itepekimab, is safe and effective.
- You will receive either the new drug, a placebo, or a standard nasal spray, plus your usual nasal steroid spray.
- The study lasts about a year and a half, with regular check-ups.
- You must have long-term sinus issues and specific symptoms to qualify.
Who may be eligible?
To join this study, you must be 18 years old or older and have had chronic rhinosinusitis with nasal polyps for at least one year. Your condition should not be fully controlled by your current treatments, meaning you still have noticeable symptoms.
Specifically, you need to have had nasal polyp surgery before, OR needed to take steroid tablets or injections for your sinus problems in the last year. When doctors examine your nose, they need to see clear evidence of nasal polyps, and you must regularly experience a blocked nose that is at least moderate or severe. You should also have either a reduced sense of smell or a runny nose as part of your symptoms.
There are also some reasons why you might not be able to join. For example, if you have other serious health problems, such as severe kidney, liver, heart, or brain conditions, or some types of digestive or blood disorders, this study might not be right for you. If you are pregnant or breastfeeding, or plan to become pregnant during the study, you would not be able to participate. Women who could become pregnant must agree to use effective birth control during and for several months after the study.
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 sinus problems with nasal polyps for at least one year?
- Have you had nasal polyp surgery before, or taken steroid tablets/injections for your sinuses in the last year?
- Do you often have a blocked nose that is moderate or severe?
- Are you not pregnant or breastfeeding, and are you willing to use effective birth control if you could get pregnant?
What does participation involve?
If you decide to take part, the study will last for up to 76 weeks – that's about a year and a half. This includes a short period (about 4 weeks) to check if you're suitable, a treatment period of up to 52 weeks (around one year), and then a follow-up period of 20 weeks to see how you're doing after treatment stops. Some people might have a slightly shorter study if they decide to join a different long-term study that follows this one.
During the study, you'll have 9 visits to the clinic or hospital. You'll also have 20 check-ins either by phone or at home. You will be given either the new study drug (itepekimab), a dummy drug (placebo), or a standard nasal spray, along with your usual nasal steroid spray. You will be told exactly how to use these medicines. The study team will regularly check your symptoms, examine your nose, and carry out other tests to see how you're responding to the treatment and to monitor your general health.
Potential risks and benefits
Locations (111)
- Excel ENT of Alabama- Site Number : 8400052Verified postcodeBirmingham, United States
- Velocity Clinical Research - San Diego- Site Number : 8400041Verified postcodeLa Mesa, United States
- Cedars-Sinai Medical Center- Site Number : 8400030Verified postcodeLos Angeles, United States
- One Of A Kind Clinical Research Center- Site Number : 8400034Verified postcodeNapa, United States
- University of Florida - Jacksonville- Site Number : 8400053Verified postcodeJacksonville, United States
- Advanced Research Institute - New Port Richey- Site Number : 8400014Verified postcodeNew Port Richey, United States
- University of Illinois at Chicago- Site Number : 8400003Verified postcodeChicago, United States
- Advanced ENT & Allergy - Louisville- Site Number : 8400007Verified postcodeLouisville, United States
- Velocity Clinical Research - Lafayette- Site Number : 8400026Verified postcodeLafayette, United States
- Johns Hopkins Hospital- Site Number : 8400017Verified postcodeBaltimore, United States
- University of Cincinnati Medical Center- Site Number : 8400022Verified postcodeCincinnati, United States
- Allergy, Asthma and Clinical Research- Site Number : 8400002Verified postcodeOklahoma City, United States
Common questions
What are nasal polyps?
Nasal polyps are soft, non-cancerous growths that can form inside your nose or sinuses, often due to long-term inflammation.
What is a 'placebo'?
A placebo is a substance or treatment that looks exactly like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects.
How long will the study treatment last?
The actual treatment with the study medicine will last for up to 52 weeks, which is about one year.
Will I know if I'm getting the active drug or the placebo?
No, neither you nor the study doctors will know who is receiving the active drug, the placebo, or the standard nasal spray until the study is over. This is called 'double-blind' and helps ensure fair results.
What kind of visits will I have?
You'll have 9 visits to the study clinic or hospital and 20 check-ins that will be done either by phone or at your home.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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