A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
This important study is investigating a new medication, lebrikizumab (also known as LY3650150), for people living with a long-term nose and sinus condition called chronic rhinosinusitis with nasal polyps (CRSwNP). Participants in the study will continue using their usual steroid nasal sprays. The main goal is to find out if lebrikizumab can effectively reduce symptoms and improve the condition, and whether it is safe to use. The study is in its advanced stages (Phase 3), meaning it's been tested before, and will run for approximately 18 months. It invites people aged 12 and older who meet specific health requirements to take part, helping researchers understand if this new treatment could offer a better option for managing CRSwNP.
At a glance
What is this study about?
This study, called CONTRAST-NP, is looking into a new treatment for a common problem called chronic rhinosinusitis with nasal polyps, often shortened to CRSwNP. This condition means you have long-lasting inflammation in your nose and sinuses, along with soft, non-cancerous growths called nasal polyps. These can make it hard to breathe through your nose, affect your sense of smell, and cause a runny nose.
The new medicine being tested is called lebrikizumab. Researchers want to see if it can help people who are already using steroid nasal sprays to manage their symptoms. Many people with CRSwNP find that their current treatments don't fully control their symptoms, so new and more effective options are always being explored.
The study aims to understand two main things: first, how well lebrikizumab works to reduce symptoms and improve the condition (this is called 'efficacy'), and second, whether it causes any unwanted side effects (this is called 'safety'). By comparing lebrikizumab to a 'placebo' (a dummy treatment) and standard care, the researchers can get a clear picture of its potential benefits and risks. The study will last for about 18 months and is a crucial step in hopefully bringing a new treatment option to people with CRSwNP.
Key takeaways
- This study is testing a new medicine called lebrikizumab for chronic rhinosinusitis with nasal polyps.
- It aims to find out if the medicine is safe and helps improve symptoms.
- Participants will continue using their regular steroid nasal sprays.
- The study lasts for about 18 months and includes adults and teenagers aged 12 and up.
- Taking part involves clinic visits, symptom checks, and possibly blood tests.
- You might receive the new medicine or a dummy treatment (placebo).
Who may be eligible?
To join this study, you need to have a doctor's diagnosis of chronic rhinosinusitis with nasal polyps affecting both sides of your nose. You should also have tried steroid tablets for your condition in the last two years, or had surgery for your polyps, or both. Your nasal polyps will be checked by a doctor using a small camera, and they need to be of a certain size.
You also need to have had ongoing symptoms, like a blocked nose (that is at least moderately severe), for at least eight weeks before starting the study. Other symptoms like a reduced or lost sense of smell, or a runny nose, are also important. If you also have asthma, it needs to be well-controlled in the three months before the study begins. The study is open to both adults and teenagers, specifically those aged 12 to under 18 who weigh at least 40 kg.
There are also reasons why you might not be able to join. For example, if you've already received lebrikizumab or needed emergency treatment or surgery for your polyps recently. You also can't join if you've recently started certain allergy treatments, or if you've used certain other powerful medications for conditions like CRSwNP, asthma, or skin conditions within a specific time frame before 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.
- Do you have a doctor's diagnosis of chronic rhinosinusitis with nasal polyps in both nostrils?
- Have you tried steroid tablets or had surgery for your polyps in the last two years?
- Do you currently have a blocked nose that is at least moderately severe?
- Are you 12 years old or older, and if you're under 18, do you weigh at least 40 kg?
- Have you stopped certain types of strong medications or allergy treatments recently?
- Is your asthma (if you have it) well-controlled and stable?
What does participation involve?
If you decide to take part in this study, it will involve several visits to the clinic over approximately 18 months. You will continue to use your standard steroid nasal sprays, and you will also be given either the study medicine, lebrikizumab, or a placebo (a dummy treatment that looks just like the study medicine but contains no active drug). You won't know which one you're receiving.
Throughout the study, the research team will regularly check your symptoms, examine your nasal polyps, and take blood tests to monitor your health and how the treatment is affecting you. You will also be asked to keep track of your symptoms at home. After the treatment period, there will be a follow-up period to see how you are doing. The exact number of visits and tests will be explained in detail by the study team.
Potential risks and benefits
Locations (194)
- AllerVie Clinical ResearchVerified postcodeBirmingham, United States· Not yet recruiting
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- Keck Medicine of USCVerified postcodeArcadia, United States· Not yet recruiting
- University of California, IrvineVerified postcodeIrvine, United States· Recruiting
- DaVinci Research LLCVerified postcodeRoseville, United States· Recruiting
- Breathe Clear InstituteVerified postcodeTorrance, United States· Recruiting
- Colorado ENT & AllergyVerified postcodeColorado Springs, United States· Recruiting
- Orlando ENT & AllergyVerified postcodeOrlando, United States· Not yet recruiting
- NuLine Clinical Trial CenterVerified postcodePompano Beach, United States· Not yet recruiting
- University of South FloridaVerified postcodeTampa, United States· Recruiting
- Treasure Valley Medical ResearchVerified postcodeBoise, United States· Recruiting
- Entopy Research LLCVerified postcodeChicago, United States· Recruiting
Common questions
What is chronic rhinosinusitis with nasal polyps (CRSwNP)?
It's a long-lasting condition where your nose and sinuses are inflamed, and you have soft growths called nasal polyps inside your nose, making it hard to breathe.
What is lebrikizumab?
Lebrikizumab is the new medicine being tested in this study to see if it can help improve symptoms of CRSwNP.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It's used in studies to compare against the new medicine.
How long will the study last?
The study will last for about 18 months in total.
Can teenagers join this study?
Yes, teenagers aged 12 to under 18 who meet the other requirements can take part.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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