Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind, Parallel Group, Multicentre Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, immunogenicity, of BP11 versus EU-Approved Xolair in patients With Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist.

This study is looking into a new medicine called BP11 for people who have chronic spontaneous urticaria, also known as chronic hives. These are hives that appear often without a clear reason and haven’t gotten better with standard allergy medications (H1 antihistamines). The study wants to see how well BP11 works compared to an already approved treatment, Xolair, and also a dummy medicine (placebo). Researchers will check if BP11 is safe, how much it helps reduce itching and spots, and how it affects people's quality of life. The main goal is to measure changes in itching after 12 weeks of treatment, but they'll also look at many other things over several months.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Curateq Biologics Private Limited

Enrolment target

474

Start

27 Aug 2024

Chronic Urticaria

What is this study about?

If you suffer from chronic hives that pop up unexpectedly and haven't responded to the usual allergy tablets, you might be interested in this study. It's investigating a new medication, known by its code BP11, to see if it can offer a better solution. The study is particularly aimed at people whose hives have proven difficult to treat with standard antihistamines.

The main purpose of this study is to compare BP11 with an existing, approved treatment called Xolair, and also with a 'dummy' treatment called a placebo. By doing this, researchers can get a very clear picture of whether BP11 is truly effective and safe. They will be looking closely at how much it reduces your itching, calms down your hives, and generally improves your day-to-day life after 12 weeks, and beyond.

This is a 'Phase 3' study, which means it's one of the final stages of testing before a new medicine might be approved for wider use. It involves many people across different locations to gather a lot of information. The researchers will be measuring various aspects of your health and well-being to understand the full impact of the treatments, from how your symptoms change to whether you experience any side effects.

Key takeaways

This study is testing a new medicine (BP11) for stubborn chronic hives.
It compares BP11 to an approved medicine (Xolair) and a dummy treatment (placebo).
It's for adults whose hives haven't responded to standard allergy tablets.
Participants will receive injections and have regular health checks.
The main goal is to see if BP11 reduces itching and improves quality of life.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You would be considered if you have chronic spontaneous urticaria, which means you get hives that appear regularly without a known cause.

Crucially, your hives must not have responded well to treatment with H1 antihistamines, which are the common allergy medications. This means you've likely tried these medications and your hives are still a significant problem for you.

There might be other specific health requirements or conditions that would prevent someone from joining, but these are the main points. The medical team will check all your details carefully to make sure the study is a safe and suitable option 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 old or older?
Do you get chronic hives (urticaria) that appear often without a clear cause?
Have your hives NOT gotten better with usual allergy tablets (H1 antihistamines)?
Are you able to attend regular clinic visits for injections and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned randomly to receive one of three treatments: the new medicine BP11, the approved medicine Xolair, or a placebo (which looks like the medicine but contains no active drug). You won't know which one you're getting, nor will your study doctor, to keep the results fair. All treatments are given as injections using a pre-filled syringe.

Your participation will involve regular visits to the study clinic over several months. At these visits, doctors and nurses will assess your hives and itching, take blood and urine samples, check your vital signs (like blood pressure), and perform physical examinations and heart tracings (ECGs). You'll also be asked to complete questionnaires about your symptoms and how they affect your quality of life. The study will monitor any side effects you experience and how much 'rescue' medication you might need for your hives. The total duration of your participation could extend beyond 24 weeks.

Potential risks and benefits

Taking part in a study like this could potentially offer you access to a new treatment that might help your chronic hives where other options haven't. Your health will be closely monitored by medical professionals throughout. However, there are potential risks, including side effects from the study medications, which could range from mild to more serious, or the possibility that the treatment may not work for you. You might also receive a placebo, meaning your hives may not improve. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Latvia
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Unverified
Bulgaria
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Unverified
Slovakia
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Unverified
Poland
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Unverified
Lithuania

Common questions

What are 'chronic hives'?

Chronic hives, or chronic spontaneous urticaria, are itchy, red, or skin-coloured raised welts (hives) that appear often, usually daily, for more than six weeks, and without a clear trigger cause.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the actual medicine but contains no active ingredient. It helps researchers understand if the real medicine is truly effective or if improvements are due to other factors.

Will I know which treatment I'm getting?

No, in this 'double-blind' study, neither you nor your study doctor will know whether you are receiving BP11, Xolair, or the placebo. This helps ensure the study results are unbiased.

What does a 'Phase 3' study mean?

A Phase 3 study is a large-scale trial that compares a new treatment to existing ones or a placebo. It's usually the final stage of testing before a new medicine can be considered for approval.

What happens if I get worse during the study?

Your health will be closely monitored. If your condition worsens or if you experience significant side effects, the study team will provide appropriate medical care and may stop your participation in the study if necessary.