Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Phase II-III study to assess the efficacy and safety of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy

This research is a study looking into a new injection-based treatment for people aged 18 and over who suffer from moderate to severe allergic rhinitis (hay fever symptoms) or rhino-conjunctivitis (hay fever symptoms with eye irritation) caused by house dust mites for at least a year. The study is comparing three different strengths (low, mid, and high dose) of a treatment called CLU-RX-DPT against a dummy injection (placebo) to see how well they reduce symptoms and if they are safe. Researchers will be tracking symptoms and medication use to understand if the new treatment can make real improvements to daily life for those with house dust mite allergies.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

ROXALL Medizin GmbH

Enrolment target

Start

12 Mar 2025

Moderate-to-severe allergic rhinitis / rhino-conjunctivitis due to house dust mites (HDM) for at least one year according to the "Allergic Rhinitis and its Impact on Asthma" (ARIA Bousquet et al.

What is this study about?

This study is about finding better ways to treat allergies to house dust mites. If you suffer from a stuffy or runny nose, sneezing, or itchy eyes because of house dust mites, you know how disruptive it can be. This research is testing a new type of treatment given by injection, which aims to train your body's immune system to react less strongly to house dust mites over time. This approach is similar to how allergy shots work.

The study is designed to answer two main questions: Firstly, how well does this new treatment, called CLU-RX-DPT, work to reduce your allergy symptoms and the need for allergy medicines? And secondly, how safe is this treatment at different doses? To find this out, participants will receive either a low, medium, or high dose of the active treatment, or a 'placebo' – which looks and feels identical to the real treatment but doesn't contain the active ingredient. This helps researchers fairly compare the effects of the treatment.

We know that living with allergies can really impact your daily life, from your sleep to your work or school activities. By taking part in this study, you could help scientists understand if this new treatment could offer real relief to people with house dust mite allergies, potentially improving their quality of life. The study will monitor symptoms, medication use, and overall well-being to get a full picture of how the treatment affects participants.

Key takeaways

This study is for adults with moderate to severe house dust mite allergy symptoms.
It's testing a new injection treatment at different strengths against a dummy injection.
The goal is to see if the treatment reduces allergy symptoms and is safe.
Participants will have regular clinic visits and track their symptoms at home.
Taking part could help improve future treatments for house dust mite allergies.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part. To be considered, you must have been diagnosed with a moderate to severe allergy to house dust mites that affects your nose (rhinitis) or both your nose and eyes (rhino-conjunctivitis) for at least one year. This means you regularly experience symptoms like sneezing, a runny or stuffy nose, or watery, itchy eyes when you're exposed to house dust mites.

Your allergy symptoms should be significant enough to be considered 'moderate to severe' according to standard medical guidelines. This helps ensure that the study is testing the treatment on people who could genuinely benefit from symptom relief.

There will be other specific medical checks during the screening process to make sure the study treatment is suitable and safe for you. This helps protect your well-being and ensures the study results are as accurate as possible.

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 suffer from moderate to severe allergy symptoms (like sneezing, runny nose, itchy eyes) caused by house dust mites?
Have you had these house dust mite allergy symptoms for at least one year?
Are you able to attend regular study appointments and keep a symptom diary?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of four groups: a low dose, mid dose, or high dose of the new treatment, or a placebo (a dummy injection with no active medicine). The treatment will be given as injections under the skin. Study appointments will involve regular visits to the clinic where you'll receive your injection. During these visits, the study team will check on your health and any side effects you might be experiencing.

You will also be asked to keep a diary of your allergy symptoms and any allergy medicines you take. This helps the researchers understand how well the treatment is working in your daily life. There will also be some specific tests, including a 'nasal provocation test', where a small amount of allergen is put into your nose to see how it reacts before and after treatment. You will also fill out questionnaires about how your allergy affects your quality of life.

The total duration of your participation in the study, including all treatments and follow-up checks, will be explained in detail by the study team. This typically involves several months to a year, but the exact schedule will be provided before you agree to join. You'll receive clear instructions and support throughout the entire process.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close monitoring by medical professionals. If the treatment is effective, it could lead to an improvement in your house dust mite allergy symptoms and a reduced need for other allergy medications. However, there are also potential risks, including side effects from the investigational treatment, which could range from mild reactions at the injection site to more significant allergic responses. As with any medical procedure, there's also the time commitment involved with study visits and assessments. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. The study team will discuss all potential benefits and risks with you in detail before you make a decision.

Locations (2)

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

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Unverified
Spain
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Unverified
Germany

Common questions

What is 'allergic rhinitis' or 'rhino-conjunctivitis'?

These are medical terms for hay fever-like symptoms. Allergic rhinitis affects your nose (sneezing, runny/stuffy nose), and rhino-conjunctivitis includes eye symptoms too (itchy, watery eyes).

What are house dust mites?

House dust mites are tiny bugs that live in dust and can trigger allergies in some people. They're a common cause of year-round allergy symptoms.

What's a 'placebo'?

A placebo is a 'dummy' treatment. It looks exactly like the real treatment but doesn't contain any active medicine. It helps researchers compare how well the real treatment works.

What does 'subcutaneous' mean?

Subcutaneous means the treatment is given as an injection just under your skin, usually in your upper arm or thigh.

Will I know if I'm getting the real medicine or the placebo?

No, usually in these types of studies, neither you nor the study staff will know whether you are receiving the active treatment or a placebo. This is to keep the study fair and unbiased.