A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants with Severe Asthma (VALIANT)
This research study, called VALIANT, is looking into a new treatment called Verekitug (also known as UPB-101) for adults who suffer from severe asthma. The main goal is to find out if this new medicine can help people have fewer severe asthma attacks over 60 weeks, which is about 14 months. We also want to understand if it improves lung function and quality of life, and check if it's safe to use. Half the participants will receive Verekitug, and the other half will get a dummy treatment that looks the same but contains no active medicine. This allows us to fairly compare the new drug's effects. Participants will receive injections and be carefully monitored throughout the study.
At a glance
What is this study about?
Living with severe asthma can be really challenging, as everyday tasks become harder due to breathing difficulties and frequent asthma attacks. Current treatments don't work for everyone, so scientists are always looking for new ways to help.
This study, named VALIANT, is testing a new medication called Verekitug (or UPB-101). It’s designed for adults whose asthma is very severe and isn’t well controlled by their usual medicines. We want to find out if Verekitug can make a real difference by reducing the number of severe asthma attacks they experience. We're also keen to see if it helps improve their breathing and overall lung health, and makes living with asthma a bit easier.
To make sure we get clear and reliable results, this study is set up very carefully. Participants will be randomly put into one of two groups: one group will receive the new Verekitug medicine, and the other will receive a dummy treatment that looks identical but doesn't contain any active drug. Neither the participants nor their doctors will know who is getting which treatment. This is called a 'double-blind' study and it’s the best way to objectively measure the medicine's effects. The study will last for 60 weeks, during which we'll closely monitor everyone's health and asthma symptoms.
Key takeaways
- This study is for adults with severe asthma seeking new treatment options.
- It tests a new medicine called Verekitug to reduce asthma attacks and improve breathing.
- Participants will receive either Verekitug or a dummy treatment via injection.
- The study lasts about 60 weeks with regular clinic visits.
- All treatment and assessments are provided at no cost.
- You can withdraw from the study at any time.
Who may be eligible?
This study is specifically designed for adults aged 18 and over who have severe asthma. There is no upper age limit, meaning older adults are welcome to participate if they meet all other study requirements.
To join, you must have severe asthma that significantly impacts your life, and your current treatments may not be fully controlling your symptoms. Both men and women are encouraged to take part in the study.
To find out if this study might be right for you, a medical team will need to review your detailed medical history and asthma management. They will check if your asthma fits the specific criteria needed for this research.
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 severe asthma that's hard to control?
- Are you willing to attend regular clinic visits for about 14 months?
- Are you comfortable receiving injections?
- Are you able to follow specific study instructions?
What does participation involve?
If you decide to take part, you'll be in the study for about 60 weeks, which is roughly 14 months. During this time, you will have regular visits to the study clinic. At these visits, doctors and nurses will monitor your health, perform breathing tests, and ask you about your asthma symptoms and how you're feeling. You will receive regular injections – these will be either the new Verekitug medicine or a dummy treatment. You won't know which one you're getting. You'll also need to complete questionnaires about your asthma and general health. All your progress will be carefully tracked to assess the treatment's effects. After the 60 weeks of treatment, there will likely be a follow-up period to see how you are doing.
Potential risks and benefits
Locations (6)
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedSpain
Common questions
What is severe asthma?
Severe asthma is a type of asthma that doesn't get better with standard treatments, meaning you might have frequent symptoms, flare-ups, and difficulty breathing, even with regular medication.
What is Verekitug (UPB-101)?
Verekitug (UPB-101) is a new medication being tested in this study to see if it can help reduce severe asthma attacks and improve breathing for people with severe asthma.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine or the dummy treatment. This helps ensure the study results are fair and unbiased.
How long will the study last?
The main treatment part of the study will last for 60 weeks, which is about 14 months. There might be some follow-up appointments after this period.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason, and it will not affect your ongoing medical care or relationship with your doctor.
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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