CDX0159-07: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX 0159 in Patients with Chronic Inducible Urticaria
This research study is investigating a new medication called Barzolvolimab for chronic inducible urticaria, a condition where people get hives triggered by specific things like cold temperatures or pressure on their skin. The study is in its second phase, meaning it's still an early look at how well the medicine works and if it's safe. Researchers want to find out if Barzolvolimab can prevent these triggered hives from appearing. They will compare different doses of the medicine against a placebo (an inactive treatment). The study will focus on people whose hives are triggered by cold (ColdU) or by scratching/pressure (SD). The main goal is to see what percentage of people no longer get hives when exposed to their usual trigger after 12 weeks of treatment.
At a glance
What is this study about?
If you get hives regularly that can be triggered by things like cold, heat, pressure, or scratching, you might have a condition called chronic inducible urticaria. This can be خیلی uncomfortable and frustrating. Researchers are always looking for better ways to help people manage these symptoms.
This particular study is looking at a new medicine called Barzolvolimab. It's a 'Phase 2' study, which means it’s still in the earlier stages of testing. The main purpose is to see how effective Barzolvolimab is at stopping these triggered hives, and to check if it's safe for people to use. They will be giving different doses of the medicine to see which works best, and comparing it to a placebo (a dummy medicine with no active ingredients). This helps them understand if any changes are truly due to the new medicine.
The study will specifically look at two common types of chronic inducible urticaria: Cold Urticaria (ColdU), where hives appear after exposure to cold, and Symptomatic Dermographism (SD), where hives appear after scratching or pressure on the skin. The main thing they want to find out after 12 weeks is if the medicine helps people stop getting hives when they are exposed to their specific trigger.
Key takeaways
- This study is for adults with chronic inducible urticaria (hives triggered by cold or pressure).
- It's testing a new medicine called Barzolvolimab against a placebo (dummy treatment).
- The main goal is to see if the medicine can stop hives from appearing when triggered.
- Participation lasts for 20 weeks of treatment, with regular health checks.
- Results from this study will help understand the medicine's effectiveness and safety.
- You won't know if you're getting the active medicine or the placebo.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to everyone, regardless of whether you are male or female.
Critically, you must have chronic inducible urticaria. This means you experience regular hives that are triggered by specific things, such as cold temperatures (called Cold Urticaria) or by scratching or pressure on your skin (called Symptomatic Dermographism). If your hives are not triggered by these specific things, this study might not be the right fit for you.
There will also be other health checks and medical conditions that the study doctors will need to review to make sure it's safe for you to take part. This will help ensure the study is suitable for your individual health situation.
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 get hives that are triggered by cold temperatures (Cold Urticaria)?
- Or do you get hives that are triggered by scratching or pressure on your skin (Symptomatic Dermographism)?
- Are you able to attend regular clinic visits for about 20 weeks?
What does participation involve?
If you take part in this study, you will be given either Barzolvolimab or a placebo (an inactive treatment). You won't know which one you are receiving, and neither will the study doctors, which helps ensure the results are fair. The treatment period will last for 20 weeks.
During this time, you will have regular visits to the study clinic. At these visits, doctors will perform specific tests to see how your hives respond to triggers. For those with cold urticaria, they'll use a special device called TempTest® to see if cold still causes hives. For those with symptomatic dermographism, they'll use a device called FricTest® to check how your skin reacts to pressure.
Throughout the study, your health will be closely monitored, and any side effects will be recorded. There will also be follow-up appointments after the main treatment period to ensure your well-being. The total duration of your involvement, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedLatvia
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedLithuania
Common questions
What is chronic inducible urticaria?
It's a type of chronic hives where specific triggers like cold, heat, pressure, or scratching cause red, itchy welts on your skin.
What is Barzolvolimab?
It's a new medication being tested to see if it can help stop these triggered hives from appearing.
What does 'Phase 2' mean for a study?
It means the study is in an earlier stage, checking to see if the medicine works and is safe before it can be tested on more people.
Will I know if I'm getting the real medicine or a placebo?
No, it's a 'double-blind' study, meaning neither you nor the doctors will know who is receiving the active medicine or the placebo until the study ends.
What happens if I want to stop participating?
You can leave the study at any point, 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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