A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Verekitug (UPB-101) in Participants with Chronic Rhinosinusitis with Nasal Polyps on a Background of Nasal Corticosteroids (VIBRANT)
This study is looking into a new medicine called Verekitug (UPB-101) for adults who have chronic rhinosinusitis with nasal polyps. This is a condition where people have a stuffy nose, often with soft, non-cancerous growths inside the nose called nasal polyps, for a long time. Even if they are already using steroid nose sprays, their symptoms might not be well controlled. The main goal is to see if Verekitug can shrink these polyps and improve symptoms. The study will also check other things like how breathing through the nose changes, how safe the medicine is, and if it reduces the need for other treatments like steroid tablets or surgery. Participants will be taking either Verekitug or a dummy medicine called a placebo to compare its effects.
At a glance
What is this study about?
This study is looking into a new medicine called Verekitug (UPB-101) for people who have a long-term stuffy nose and problems with their sinuses because of growths called nasal polyps. You might know this as 'chronic rhinosinusitis with nasal polyps.' Even if you're already using nasal steroid sprays, you might still experience a blocked nose, reduced sense of smell, or discomfort due to these polyps. This study wants to find out if Verekitug can offer a better way to manage these annoying symptoms.
Nasal polyps are soft, non-cancerous swellings that can grow inside the nose and sinuses. They can make it hard to breathe, affect your sense of smell, and sometimes cause a runny nose or facial pressure. The current treatments often include steroid nose sprays, but some people still struggle. That's why researchers are looking for new options to help people feel better.
In this study, researchers will compare Verekitug to a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps the researchers truly understand if any improvements are due to Verekitug itself or something else. They will be carefully watching to see if Verekitug helps shrink the polyps, improve your breathing, and generally make you feel better, while also checking for any unwanted side effects.
Key takeaways
- This study is testing a new medicine for nasal polyps and chronic stuffy nose.
- It aims to see if the new medicine, Verekitug, can shrink polyps and reduce symptoms.
- Participants will receive either the new medicine or a dummy treatment (placebo).
- The study involves regular clinic visits for symptom checks and safety monitoring.
- It's for adults already using steroid nasal sprays for their condition.
- The main treatment part of the study lasts for about 6 months.
Who may be eligible?
To be able to join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet other criteria.
This study is open to both men and women. The main requirement is that you have a specific long-term condition called chronic rhinosinusitis with nasal polyps.
You'll also need to be currently using steroid nose sprays, as the study is designed to see if Verekitug can help when these usual treatments aren't enough on their own.
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 long-term chronic rhinosinusitis with nasal polyps?
- Are you currently using steroid nose sprays for your condition?
- Are you comfortable with regular clinic visits and injections?
What does participation involve?
If you decide to take part in this study, you would be given either the new medicine, Verekitug, or a dummy medicine (placebo) by an injection just under your skin. You wouldn't know which one you are receiving, and neither would your study doctor, to make sure the results are as fair as possible.
Over 24 weeks (about 6 months), you would have regular visits to the clinic. During these visits, the study team would check your nasal polyps, assess your breathing and other symptoms, and ask about how you're feeling. They would also do physical exams, take blood samples, check your heart, and record your vital signs like blood pressure and pulse. After this 24-week period, there will be a follow-up period to continue monitoring your health and any side effects. The total duration of your involvement could be several months.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What are nasal polyps?
Nasal polyps are soft, non-cancerous growths inside your nose or sinuses that can cause stuffiness and other symptoms.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you're getting the active medicine or a dummy medicine (placebo).
How is the study medicine given?
The study medicine is given as an injection just under your skin.
How long will the main part of the study last?
The main treatment period is about 24 weeks, or 6 months, followed by a monitoring period.
Can I stop participating in the study?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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