Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of briquilimab in participants with allergic asthma.

This research study is for adults aged 18 and over who have allergic asthma. We're testing a new medication called briquilimab to see if it's safe and effective in helping to manage asthma symptoms. Participants will be split into two groups: one group will receive the new medicine, and the other will receive a 'dummy' treatment, known as a placebo. Neither you nor your study doctor will know which treatment you are receiving until the study is over. This helps us get a clear picture of how well the new medicine works. The study is an early-stage trial, focusing on understanding the medicine's effects in people. Your involvement could help us learn more about potential new treatments for allergic asthma.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Jasper Therapeutics Inc.

Enrolment target

Start

24 Oct 2024

allergic asthma

What is this study about?

This study is designed to look into a new medicine called briquilimab for people who have allergic asthma. Allergic asthma means your asthma symptoms are often triggered by things like pollen, dust mites or pet dander. Researchers want to find out if this new medicine can help reduce your asthma symptoms and how safe it is to use.

To make sure we get clear and reliable results, this study uses a special design. Some people will get the actual medicine (briquilimab), while others will receive an inactive substance, often called a 'dummy' medicine or placebo. Importantly, neither you nor the study team will know who is getting which treatment. This is called 'double-blind' and it helps to ensure that everyone is treated the same and that any changes observed are truly due to the medicine and not other factors.

This is an early stage of testing, sometimes called a Phase 1 study. This means it's one of the first times this medicine is being given to people. The main goals at this stage are to check if the medicine is safe, to understand how it behaves in the body, and to see if it shows any signs of helping with allergic asthma. By taking part, you could be helping to advance our understanding of new ways to treat allergic asthma in the future.

Key takeaways

Tests a new medicine (briquilimab) for allergic asthma.
Aims to check safety and if it helps asthma symptoms.
Participants will get either the new medicine or a dummy treatment.
Neither you nor the doctors will know which treatment you receive.
Open to adults aged 18 and over, both men and women.
Your participation could help future treatments for asthma.

Who may be eligible?

This study is looking for a wide range of adults to take part. To be considered, you must be 18 years old or older. There is no upper age limit for joining this study, so people of many different adult ages can be considered.

The study is open to both men and women. We want to include a diverse group of people to make sure the results are as useful as possible for everyone who might have allergic asthma.

Beyond these general points, there will be other specific health requirements that the study team will discuss with you. These are in place to ensure your safety and that the study can gather accurate information. For instance, they will need to confirm you have a diagnosis of allergic asthma and may ask about other health conditions or medications you are currently taking.

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 a diagnosis of allergic asthma?
Are you able to attend regular study appointments?
Are you willing to potentially receive either the new medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the necessary requirements. This might involve blood tests, physical exams, and discussions about your health history and asthma. If you qualify and choose to join, you would be assigned to either receive the new medicine, briquilimab, or a placebo.

Throughout the study, you would attend several clinic visits where the study team would monitor your health, check for any possible side effects, and assess your asthma symptoms. You might have repeat blood tests, lung function tests, and fill out questionnaires about how you are feeling. You would also receive the study medication (or placebo) according to a set schedule.

There would be regular follow-up appointments to track your progress and ensure your well-being. The total duration of your participation would be explained to you in detail by the study team, including how long you would be taking the study medicine and any follow-up periods after you stop taking it. All these details, including the number and frequency of visits, will be clearly outlined before you agree to participate.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of joining this study is that you might directly receive a new medicine that could improve your asthma symptoms if briquilimab proves effective. Your participation also contributes valuable information that could help others with allergic asthma in the future. However, there's also a chance you could receive the placebo and not experience any direct benefit from the study medicine. As with any new medicine, there's always a risk of experiencing side effects that are currently unknown or unexpected. The study team will monitor you closely for any adverse reactions. You have the right to withdraw from 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 allergic asthma?

Allergic asthma is a type of asthma where your breathing problems are triggered by things you are allergic to, like pollen, dust mites, or pet dander.

What is a 'double-blind' study?

It means neither you nor your study doctor will know if you're getting the new medicine or a dummy treatment. This helps make the study results fair and accurate.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the new medicine's effects.

What phase is this study?

This is an early-stage study, often called Phase 1. It mainly focuses on checking the safety of the new medicine and how it works in the body for the first time in people.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, and it will not affect the ongoing care you receive for your asthma.