Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects with Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis with or without Asthma Induced by House Dust Mite (HDM) Allergy

This research study is looking into a new treatment called PURETHAL Mites. It's a type of injection designed to help adults who suffer from allergy symptoms, like hay fever or asthma, which are triggered by house dust mites. The study wants to see how well this injection works compared to a 'dummy' treatment (a placebo), which contains no active medicine. Researchers will be carefully checking if PURETHAL Mites can reduce allergy symptoms such as sneezing, runny nose, itchy eyes, and breathing problems over several weeks. It's a large study happening in many different places, aiming to prove if this treatment is effective and safe for people with these specific allergies.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

HAL Allergy B.V.

Enrolment target

582

Start

11 Jan 2024

Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis with or without Asthma Induced by House Dust Mite (HDM) Allergy

What is this study about?

This study is all about helping adults who have uncomfortable allergy symptoms because of house dust mites. These mites are tiny creatures that live in our homes and can cause problems like a runny nose, sneezing, itchy eyes, and even asthma in some people. This type of allergy is often called allergic rhinitis or rhinoconjunctivitis, and it can be quite bothersome.

The researchers are testing a special injection called PURETHAL Mites. This treatment works by gradually training your immune system (your body's defence system) to be less sensitive to house dust mites. It's a bit like giving your body small, controlled doses of the mite allergy trigger so it learns to ignore it, rather than overreacting. The ultimate goal is to reduce how often and how severely you experience allergy symptoms.

To make sure the results are fair and accurate, some people in the study will receive the PURETHAL Mites injection, while others will get a 'dummy' injection called a placebo. A placebo looks exactly like the real treatment but doesn't contain any active medicine. Neither you nor your doctor will know whether you're getting the active treatment or the placebo – this is called 'double-blind' and it helps to ensure the study is unbiased. By comparing the two groups, the researchers can figure out if PURETHAL Mites truly makes a difference. This is a large-scale study, called a Phase III trial, which is typically the last stage before a new medicine might be approved for wider use.

Key takeaways

This study tests a new injection for house dust mite allergy symptoms.
It's for adults (18+) with moderate to severe hay fever-like symptoms or asthma caused by these mites.
Participants will receive either the new treatment or a dummy injection (placebo).
Symptoms, lung function, and safety will be carefully monitored throughout the study.
The aim is to reduce allergy symptoms and improve quality of life.
Participation involves regular clinic visits and tracking daily symptoms.

Who may be eligible?

This study is specifically for adults who are 18 years old or older. There's no upper age limit, meaning older adults can also take part.

To be considered for the study, you must have symptoms of moderate to severe allergic rhinitis (like hay fever) or rhinoconjunctivitis (hay fever with eye symptoms), or asthma, which are directly caused by an allergy to house dust mites. Your doctor will carry out tests to confirm this allergy.

Both men and women can participate in this research. The study needs participants whose daily life is noticeably affected by their house dust mite allergy.

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 moderate to severe hay fever-like symptoms (runny nose, sneezing, itchy eyes) or asthma?
Has a doctor told you that your symptoms are caused by an allergy to house dust mites?
Are your allergy symptoms noticeable and bothersome in your daily life?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to your study doctor or clinic. During these visits, you will undergo tests to confirm your house dust mite allergy, such as skin prick tests. You will receive regular injections of either the new treatment (PURETHAL Mites) or a placebo (dummy injection) under your skin. Throughout the study, you'll be asked to keep a daily record of your allergy symptoms, like sneezing, runny nose, and itchy eyes, and any medicine you take for them. Researchers will also check your lung function, especially if you have asthma, and monitor your overall health for any side effects. The total duration of your participation will include the treatment period and follow-up, which could extend over several months.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new and potentially effective treatment for your house dust mite allergy, which could improve your symptoms. You'll also be closely monitored by medical professionals. However, there are potential risks, including side effects from the injections, which could be local (like redness or swelling at the injection site) or more general allergic reactions. You might also receive the placebo, meaning your allergy symptoms may not improve. It's 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
Lithuania
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Unverified
Germany
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Unverified
Latvia
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Austria

Common questions

What are house dust mites?

House dust mites are tiny insects that live in bedding, carpets, and furniture. Many people are allergic to their droppings, which can cause hay fever-like symptoms or asthma.

What is allergic rhinitis/rhinoconjunctivitis?

These are medical terms for allergy symptoms affecting your nose (like a runny or blocked nose, sneezing) and/or your eyes (like itchiness, watering, redness). It's often called hay fever.

What does 'double-blind' mean in a study?

This means neither you nor your study doctor will know if you're receiving the active treatment or a dummy injection (placebo). This helps make the study results as fair as possible.

Will I definitely get the new treatment?

No, because it's a 'double-blind, placebo-controlled' study, there's a chance you'll receive the placebo (dummy injection) instead of the active PURETHAL Mites treatment.

What does a 'Phase III' study mean?

Phase III is the stage where a new treatment is widely tested in a large group of people to confirm its effectiveness and safety before it can be considered for general use.