Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients with Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment with H1-Antihistamines

This research study is investigating a new medication called briquilimab. It's for adults who experience chronic inducible urticaria (CIndU), which are hives that appear when triggered by things like cold or pressure, and haven't improved with standard antihistamine treatments. The main goals are to find out if briquilimab is safe, what side effects it might cause, and how it moves through the body. We also want to see if it helps relieve hive symptoms and how well people respond to it. This study is going through early phases of testing to gather important information before it can be considered for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Jasper Therapeutics Inc.

Enrolment target

Start

22 Dec 2023

Chronic Inducible Urticaria

What is this study about?

Imagine you get hives regularly, not just from allergies, but from things like cold weather, pressure on your skin, or even sunlight. This is called chronic inducible urticaria (CIndU). For many people, common allergy medicines (antihistamines) don't fully stop these bothersome hives. This study is looking into a new medicine, briquilimab, to see if it can help.

This study is in its early stages (called Phase 1b/2a). This means we're carefully checking a few important things. Firstly, we want to make sure the medicine is safe and identify any potential side effects. We'll also be trying different doses to see which one works best while still being safe. Secondly, we're studying how briquilimab acts in the body – how much is absorbed, how long it stays, and how it affects the body's systems.

Finally, we want to see if briquilimab actually helps reduce your hives and makes you feel better. This is an important step in developing new treatments for CIndU, especially for those who haven't found relief with current options. The information we gather will help us understand if briquilimab could be a promising new treatment in the future.

Key takeaways

This study explores a new medicine, briquilimab, for chronic inducible hives (CIndU).
It's for adults whose hives remain bothersome despite antihistamine treatment.
The primary focus is on safety, side effects, and how the medicine works in the body.
Researchers will also be looking for initial signs that it helps reduce hive symptoms.
You'll have very close medical supervision throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and older, regardless of their sex. You can take part if you have chronic inducible urticaria (CIndU), which means you get hives regularly when exposed to specific triggers like cold, pressure, or heat.

Crucially, you would be suitable if your CIndU symptoms are still bothering you, even after you've been taking H1-antihistamine medication as prescribed. This study is for people whose current treatment isn't quite controlling their hives.

To find out if you're a good fit, the study team will ask you some questions about your health and medical history, and may do some simple tests. This is to make sure the study is safe for you and that you meet all the specific requirements.

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) triggered by specific things like cold or pressure?
Are your hives still a problem, even though you take antihistamine medication?
Are you able to attend regular clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the new medicine, briquilimab. You'll also be given epinephrine, which is a medicine used in emergencies, alongside training on how to use it, just as a safety precaution. You would have regular visits to the clinic where the study team will monitor your health very closely. This includes checking for any new symptoms or side effects (like changes in taste or hair colour), and taking blood samples to see how the medicine is working in your body. They'll also check your heart with an ECG and monitor your vital signs like blood pressure.

To see how well the medicine is working for your hives, you might undergo certain 'provocation tests'. For example, if cold triggers your hives, they might carefully check how cold your skin needs to be before hives appear. You'll also be asked to complete questionnaires, like the Urticaria Control Test, to describe how your hives are affecting you. The total length of your involvement in the study will be explained by the study team, and it involves regular follow-up to track your progress and any changes over time.

Potential risks and benefits

Participating in this study might offer you a potential benefit: you could gain access to a new treatment, briquilimab, that might help control your chronic hives, especially if other medicines haven't worked for you. However, like all medicines, briquilimab could cause side effects, some of which we might not know about yet, or it might not help your symptoms. The study team will monitor you very closely for any side effects and your safety is their priority. You always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is Chronic Inducible Urticaria (CIndU)?

CIndU means you get hives (urticaria) that are triggered by specific things like cold, pressure, heat, or water, rather than just from allergies.

What is an H1-antihistamine?

This is a common type of allergy medicine that helps reduce itching and hives, often available over-the-counter or from your doctor.

What does 'Phase 1b/2a' mean for a study?

It means it's an early stage study. Phase 1 focuses on safety and finding the right dose, while Phase 2 starts looking at how well the medicine works.

Will I get 'epinephrine' in this study?

Yes, you will be given epinephrine and training on how to use it. This is a standard safety measure in some drug trials, in case of a severe reaction, though such events are rare.

Will I know if I'm getting the actual medicine or a dummy treatment?

The study design will be fully explained by the research team. Some studies use a placebo (dummy treatment) for comparison, while others may not. This will be made clear to you.