A randomized, double blind, placebo controlled, Proof of Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab in participants with inadequately controlled chronic rhinosinusitis without nasal polyps
Chronic rhinosinusitis is a long-term swelling of the passages inside your nose and face. It causes distressing symptoms like a blocked nose, facial pressure, and a lost sense of smell. This Phase 2 study is testing a new medicine called itepekimab in adults whose sinus problems remain poorly controlled despite previous treatments. The trial is specifically for people who do not have nasal polyps, which are soft growths inside the nose. Participants will receive either itepekimab or a dummy treatment (placebo) to fairly test if the medicine works. Doctors will use CT scans to see if sinus blockages improve. Participants will also keep an electronic daily diary to track changes in pain, stuffiness, and general quality of life. The research team will watch participants closely throughout the study to ensure their safety and monitor any side effects.
At a glance
What is this study about?
Chronic rhinosinusitis is an ongoing inflammation of the lining inside your nose and sinuses. Sinuses are the air-filled spaces behind your cheeks, forehead, and eyes. When these spaces remain swollen and blocked for months, people often struggle with a blocked nose, constant facial pain or pressure, and a reduced sense of smell. For many individuals, everyday treatments like saline washes and steroid nasal sprays simply do not provide enough relief.
This clinical study focuses on chronic rhinosinusitis without nasal polyps. Nasal polyps are soft, non-cancerous growths inside the nose. While treatments exist for people who have polyps, there are fewer targeted options for those who do not have them. Researchers are testing a new medicine called itepekimab to see if it can calm down the body's inflammatory signals, clear the sinuses, and make breathing easier.
During the trial, doctors will evaluate how well itepekimab clears sinus blockages by taking detailed pictures of the head using CT scans. They will also look at how everyday life improves for participants, measuring changes in facial discomfort, runny nose, and sleep. Finding a reliable new medicine could offer much-needed hope to people living with persistent sinus trouble.
Key takeaways
- Tests a new medicine called itepekimab for long-term sinus inflammation.
- Designed for adults aged 18 and over who do not have nasal polyps.
- Compares the study medicine against a dummy treatment (placebo) to test its safety and effectiveness.
- Uses CT scans and daily symptom diaries to see if sinus blockages and pain improve.
- Joining is entirely voluntary and does not impact your normal NHS medical care.
Who may be eligible?
This study is open to adults aged 18 and over who have long-standing sinus problems that are not adequately controlled by their usual treatments. To be considered, you must have chronic rhinosinusitis without nasal polyps.
Before taking part, a doctor will carry out health checks and scans to confirm that your sinuses are inflamed and that there are no polyps present. They will also review the treatments you have tried in the past to make sure your condition meets the study criteria.
You may not be eligible if you have certain other medical conditions, severe respiratory illnesses, or if you are taking medications that could interfere with the study medicine. The trial doctor will review your complete medical history to check whether the trial is safe and suitable for 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 of age or older?
- Have you had ongoing sinus problems lasting for months that do not improve with standard medicines?
- Has a doctor confirmed that you do not have nasal polyps?
- Are you willing to attend regular hospital appointments and have sinus CT scans?
- Can you complete a simple daily electronic diary to record your symptoms?
What does participation involve?
Taking part involves receiving either itepekimab or a placebo (a dummy treatment that looks identical but has no active ingredient). A computer will randomly decide which treatment you receive, and neither you nor your doctor will know which one you are given.
You will need to attend regular clinic visits at a hospital or trial centre. At these visits, doctors will monitor your health, take blood samples, and perform CT scans to look at your sinuses. You will also use an electronic diary on a handheld device every day to record your symptoms, such as facial pain, blocked nose, and sense of smell. The study team will provide close medical follow-up throughout the treatment period and for several weeks afterwards to ensure your wellbeing.
Potential risks and benefits
Locations (7)
- —UnverifiedPortugal
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
Common questions
What is chronic rhinosinusitis without nasal polyps?
It is an ongoing swelling and irritation of the sinus lining lasting 12 weeks or longer, where no soft grape-like growths (polyps) are found inside the nasal passages.
What is a placebo?
A placebo looks identical to the real trial medicine but contains no active ingredients. It helps researchers prove whether the actual medicine is truly effective or if changes are happening by chance.
Will I know if I am getting the real medicine?
No. This is a double-blind trial, which means neither you nor the study doctors will know which treatment you are receiving until the trial is complete.
Do I have to pay to take part in the study?
No. All study-related medicines, tests, and medical visits are provided free of charge, and travel expenses are often covered.
Can I stop taking part if I change my mind?
Yes. You can leave the study at any point. Your decision will not affect the standard of care you receive from your usual doctors or the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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