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Ongoing Clinical Trials for Mite Allergy

There are currently 5 clinical trials underway exploring new treatments for people with allergies to house dust mites. These trials are testing different forms of immunotherapy, including injections and sublingual sprays, aimed at reducing symptoms such as sneezing, runny nose, itchy eyes, and breathing difficulties. The trials are being conducted in Spain and Portugal, and are open to participants aged 12 to 65 years old.

Clinical trial locations

Study on the Effectiveness and Safety of Beltavac for Patients with Allergic Rhinitis from House Dust Mites

This trial is testing a treatment called Beltavac, which is given as an injection under the skin. The treatment aims to help people who experience allergic rhinitis and rhinoconjunctivitis caused by house dust mites.

Who can join: Participants must be between 12 and 65 years old with moderate or severe symptoms of ongoing rhinitis. They need to have a positive skin prick test showing sensitivity to house dust mites, with a raised area of 3 mm or more, and specific allergy antibody levels of class 3 or higher. Women who can become pregnant must use contraception and have a negative pregnancy test. Participants also need to be willing to keep track of their symptoms and medication use in an electronic diary during a 4-week screening period and a 12-week treatment period.

Who cannot join: People with severe allergies to the treatment, a history of serious allergic reactions called anaphylaxis, those currently taking medications that could interfere with the study, pregnant or breastfeeding women, and those who have participated in another clinical trial within the last 30 days cannot participate. People unable to follow study procedures are also excluded.

What the trial involves: The study lasts for 12 months, during which participants receive subcutaneous injections of Beltavac, which contains modified extracts from house dust mites. The goal is to see if the treatment can reduce symptoms like sneezing, runny or blocked nose, and itchy eyes. Participants will track their symptoms and medication use in an online diary to help researchers understand how well the treatment works.

Investigational drug: Beltavac is a form of immunotherapy that works by gradually training the immune system to become less sensitive to house dust mite allergens.

Study on the Effectiveness and Safety of Sublingual MM09 for Patients Aged 12-65 with Allergies to House Dust Mites and Rhinitis/Rhinoconjunctivitis with or without Asthma

This trial is testing Sublingual MM09, a spray used under the tongue, designed to help the body become less sensitive to house dust mites over time. It is being compared to a placebo.

Who can join: Participants must be aged 12 to 65 with a confirmed allergy to house dust mites, showing moderate to severe rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. They need a positive skin prick test with a wheal of at least 5 mm and specific allergy antibody levels of 3.5 kU/L or higher. Participants must own a smartphone to record symptoms and medication use, and women of childbearing age must use contraception and have a negative pregnancy test.

Who cannot join: People with severe, uncontrolled asthma, pregnant or breastfeeding women, those currently participating in another trial, individuals with known allergies to the study medication, and those with a history of severe allergic reactions cannot participate. People unable to follow study procedures are also excluded.

What the trial involves: Participants use the sublingual spray daily for 12 months. They keep a diary of symptoms and medication use to help assess how well the treatment reduces allergy symptoms and the need for other medications. The study is double-blind, meaning neither participants nor researchers know who receives the actual treatment or placebo.

Investigational drug: Sublingual MM09 contains extracts from house dust mites and is administered under the tongue to gradually desensitize the immune system.

Study on the Effectiveness and Safety of Mannan-Conjugated Allergoids for Treating Allergic Rhinitis/Rhinoconjunctivitis in Patients Allergic to House Dust Mites

This trial evaluates a vaccine called Mannan-conjugated allergoid, given as an injection under the skin, to help people build tolerance to house dust mite allergens.

Who can join: Participants must be between 12 and 65 years old with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma. They need a positive skin prick test showing a wheal of at least 5 mm and specific allergy antibody levels of at least 3.5 kU/L. Participants must record symptoms and medication use in a diary. Women of childbearing age need a negative pregnancy test and must use reliable contraception.

Who cannot join: People not allergic to the specific dust mites being studied, those without moderate-to-severe persistent symptoms, individuals younger than 12 or older than 65, and those considered part of a vulnerable population cannot participate.

What the trial involves: Participants receive subcutaneous injections of the Mannan-conjugated allergoid vaccine at a dosage of 3,000 mTU/mL. The study monitors how well the treatment reduces allergy symptoms and medication use over time. Regular follow-up visits assess response to treatment and any side effects.

Investigational drug: EP-088_MM09 uses modified proteins from dust mites to help reduce allergic reactions and improve quality of life for those with house dust mite allergies.

Study on the Effectiveness and Safety of Mannan-Conjugated Allergoids for Treating Allergic Rhinitis/Rhinoconjunctivitis in Patients Allergic to House Dust Mites

This trial is testing another version of the Mannan-conjugated allergoid vaccine, given as an injection under the skin, to evaluate its effectiveness in reducing symptoms of rhinitis and rhinoconjunctivitis.

Who can join: Participants must be aged 12 to 65 with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma. They need a positive skin prick test with a wheal of at least 5 mm and specific allergy antibody levels of at least 3.5 kU/L. Participants must keep a symptom and medication diary. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception.

Who cannot join: People not allergic to the specific dust mites, those without moderate-to-severe persistent symptoms, individuals younger than 12 or older than 65, and those from vulnerable populations are excluded.

What the trial involves: Participants receive regular subcutaneous injections of the vaccine at a dosage of 3,000 mTU/mL over approximately one year. The study tracks symptom improvement and medication use through participant diaries and questionnaires about quality of life and asthma control.

Investigational drug: EP-088_MM09 targets specific allergens from dust mites to help reduce allergic reactions through immunotherapy.

Study on the Effectiveness and Safety of Clustoid MM09 for Patients with Allergic Rhinitis or Rhinoconjunctivitis, with or without Mild to Moderate Asthma

This trial tests Clustoid MM09, a vaccine given as an injection under the skin, containing modified extracts from house dust mites to help reduce allergy symptoms.

Who can join: Participants must be between 12 and 65 years old with moderate to severe rhinitis or rhinoconjunctivitis, with or without controlled mild to moderate asthma. They need a positive skin prick test showing a reaction of 5 mm or larger and specific allergy antibody levels greater than 3.5 KU/L. Participants must own a smartphone to record symptoms and medication use. Women of childbearing age need a negative pregnancy test and must agree to use effective contraception if sexually active.

Who cannot join: People with severe unrelated health conditions, recent severe allergic reactions requiring emergency treatment, uncontrolled asthma, pregnant or breastfeeding women, and those unable to follow study procedures cannot participate.

What the trial involves: The study lasts up to 12 months, with participants receiving regular subcutaneous injections of Clustoid MM09 or placebo. Neither participants nor researchers know who receives which treatment. Participants track symptoms and medication use via a smartphone app, helping researchers assess the vaccine’s effectiveness.

Investigational drug: Clustoid MM09 contains polymerized allergen extracts designed to gradually desensitize the immune system to dust mite allergens, reducing symptoms of rhinitis, rhinoconjunctivitis, and asthma.

Summary

All five trials focus on immunotherapy approaches to treat allergies to house dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. The trials are concentrated in Spain and Portugal, with Spain hosting all five studies and Portugal hosting three. Four trials test injectable vaccines given under the skin, while one evaluates a sublingual spray. All trials target participants aged 12 to 65 with moderate to severe symptoms of allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma.

The investigational drugs being tested include Beltavac, Sublingual MM09, EP-088_MM09 (Mannan-conjugated allergoids), and Clustoid MM09. These treatments aim to gradually train the immune system to become less sensitive to dust mite allergens, potentially reducing symptoms like sneezing, runny nose, itchy eyes, and breathing difficulties. Most trials last approximately 12 months and require participants to track their symptoms and medication use throughout the study period.

These trials represent important research into new treatment options for people suffering from house dust mite allergies, offering hope for improved symptom management and quality of life.

Ongoing Clinical Trials on Mite allergy

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