AuthorisedTherapeutic confirmatory (Phase III)Interventional

Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial to evaluate efficacy and safety of immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Blomia tropicalis

This research study is investigating a new immunotherapy treatment for people who experience moderate to severe allergic rhinitis (hay fever symptoms like sneezing, runny nose, and itchy eyes) and conjunctivitis (itchy, watery eyes). Some participants may also have mild to moderate asthma. The allergies are caused by dust mites and specific tropical dust mites. The study aims to find out if the new treatment is safe and effective in reducing symptoms and the need for other allergy medicines. Participants will be given either the active treatment or a placebo (a dummy treatment) through injections. Researchers will carefully check how participants' symptoms change over a year.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Inmunotek S.L.

Enrolment target

120

Start

18 May 2026

Aetiological treatment of moderate-to-severe allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate controlled allergic asthma

What is this study about?

This clinical trial is designed to test a new type of treatment for people who suffer from allergies, specifically to common dust mites and another type of tropical dust mite. If you have been diagnosed with moderate to severe allergic rhinitis (also known as hay fever, which causes symptoms like sneezing, a runny nose, and itchy eyes) or rhinoconjunctivitis (which adds itchy, watery eyes to the mix), this study might be relevant to you. Some people in the study may also have mild to moderate asthma that is under control, as these conditions often go hand-in-hand with allergies.

The main goal of this study is to see if this new treatment can make your allergy symptoms better and reduce how much other allergy medication you need to take. This special treatment, called immunotherapy, works by giving you tiny, increasing doses of the things you're allergic to, hoping to help your body get used to them and stop overreacting. For this study, you would receive injections containing very small, specially prepared amounts of dust mite allergens. We are also looking very carefully at the safety of this new treatment.

This is a 'Phase III' study, which means the treatment has already been tested in earlier stages and shown some promise. Now, we need to confirm its effectiveness and safety in a larger group of people. Participants will be split into two groups: one receiving the active treatment and the other receiving a placebo, which looks exactly the same but contains no active ingredients. This helps researchers fairly assess the true effects of the new treatment.

Key takeaways

This study tests a new allergy injection for dust mite allergies.
It aims to improve hay fever symptoms and reduce the need for other allergy medicines.
Participants will get either the active treatment or a placebo injection.
The study lasts for about one year and involves regular clinic visits.
Your symptoms will be tracked daily using a diary.
It's a 'Phase III' study, meaning the treatment has shown promise in earlier tests.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. There is no upper age limit. Both men and women can take part.

You should have moderate to severe allergic rhinitis (hay fever symptoms) or rhinoconjunctivitis (hay fever plus eye symptoms). You might also have asthma, but it needs to be mild to moderate and well-controlled by your current medication. Your allergies must be specifically to certain types of dust mites.

There will be other specific health checks to ensure the study is safe and appropriate for you, but the main criteria are your age and type of allergic conditions.

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 moderate to severe hay fever symptoms (rhinitis/rhinoconjunctivitis)?
Are your allergies caused by dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae, and/or Blomia tropicalis)?
If you have asthma, is it mild to moderate and well-controlled?
Are you able to attend regular appointments for one year and keep a daily diary?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be expected to attend regular appointments for about a year. During these visits, you will receive injections – either the active treatment or a dummy (placebo) injection. These injections will look identical. You will also be asked to keep a daily diary to record your symptoms, how severe they are, and any other allergy medications you take. This diary is very important as it helps the researchers understand how well the treatment is working.

Throughout the study, researchers will monitor your symptoms, lung function if you have asthma, and your general health. They will also collect blood samples at certain times to check how your immune system is responding to the treatment. There will be questionnaires to fill out about your quality of life. The total duration of the treatment and observation period will be one year, followed by further assessments.

Potential risks and benefits

Participating in this study might offer a potential benefit of reducing your allergy symptoms and your need for allergy medications. However, there's no guarantee the treatment will work for everyone, as some participants will receive a placebo. Potential risks could include reactions at the injection site, like redness or swelling, or more widespread allergic reactions, although these are closely monitored. Your safety is a priority, and medical staff will be on hand. You have the right to withdraw from the study at any time, for any reason, without 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
Spain

Common questions

What is immunotherapy?

Immunotherapy is a treatment that helps your body get used to the things you're allergic to, reducing your allergic reactions over time.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real treatment but doesn't have any active ingredients. It helps researchers fairly test the new treatment.

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

No, neither you nor the study doctors will know during the study. This is called 'double-blind' and helps ensure fair results.

What conditions is this study looking at?

It's for people with moderate to severe allergic rhinitis (hay fever) or rhinoconjunctivitis (hay fever with eye symptoms), possibly with mild asthma, caused by dust mites.

How long will the study last if I join?

The treatment and observation period for this study will last for about one year.