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

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What is this study about?

This clinical trial is focused on studying the treatment of allergic rhinitis and rhinoconjunctivitis, which are conditions that cause symptoms like a runny nose, sneezing, and itchy eyes. These symptoms are often triggered by allergies to house dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. The study will use a special vaccine called the mannan-conjugated allergoid vaccine, which is designed to help the body build a tolerance to these allergens. This vaccine is given as an injection under the skin.

The purpose of the study is to evaluate how effective and safe this vaccine is for people aged 12 to 65 who have moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma. Participants will receive either the vaccine or a placebo, which looks like the vaccine but does not contain the active ingredients. The study will last for about a year, during which participants will receive regular injections and will be asked to keep track of their symptoms and any medications they use in a diary.

Throughout the study, participants’ symptoms and medication use will be closely monitored to assess the vaccine’s effectiveness. The study will also look at various health measures, including the quality of life related to asthma and rhinitis, and any side effects that may occur. The goal is to determine if the vaccine can help reduce the symptoms of allergic rhinitis and rhinoconjunctivitis and improve the overall quality of life for those affected by these conditions.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and medical history. You will also be required to sign an informed consent form, indicating your understanding and agreement to participate in the study.

A pregnancy test will be conducted for women of childbearing age to ensure eligibility. You will also be asked to record your symptoms and medication use in an electronic or paper diary.

2 baseline visit

At the baseline visit, your symptoms and medication use will be recorded. This information will help establish a starting point for the trial. You will be instructed on how to continue recording this information throughout the study.

3 treatment phase

During the treatment phase, you will receive a subcutaneous injection of the study medication, which is a mannan-conjugated allergoid vaccine. The dosage is 3,000 mTU/mL. This phase is designed to evaluate the efficacy of the treatment compared to a placebo.

The injections will be administered according to a schedule provided by the study team. You will continue to record your symptoms and any medication use in your diary.

4 follow-up visits

Throughout the trial, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment. Your symptoms, medication use, and any side effects will be assessed.

You will also be asked to complete questionnaires about your quality of life and asthma control, if applicable.

5 end of treatment

At the end of the treatment phase, a final assessment will be conducted. This will include a review of your recorded symptoms and medication use, as well as any changes in your condition.

You will be asked to complete final questionnaires to evaluate the overall impact of the treatment on your quality of life and symptom control.

Who Can Join the Study?

Participants must sign and date an Informed Consent Form, which is a document that explains the study and confirms their willingness to participate.
Participants need to record their symptoms and any medication they take in an electronic diary on a smartphone or in a paper diary.
Participants must have a combined symptom and medication score of at least 2 out of 6 for at least 10 days, indicating moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
Participants must be between 12 and 65 years old.
Participants should have a confirmed history of inhalation allergy with moderate-severe persistent rhinitis/rhinoconjunctivitis for at least 1 year, with or without mild-to-moderate controlled asthma, caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. Asthma diagnosis must be valid up to 12 months before signing the informed consent.
Participants must have a positive skin prick test, which is a test where a small amount of allergen is placed on the skin to see if there is a reaction, showing a wheal (bump) of at least 5 mm in diameter to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The results must be valid up to 12 months before signing the informed consent.
Participants must have specific IgE (a type of antibody) against a complete extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae with a value of at least 3.5 kU/L. The results must be valid up to 12 months before signing the informed consent.
Participants should preferably be sensitive only to the study allergens. If sensitive to other allergens, specific conditions must be met, such as having a positive skin prick test for certain allergens with specific IgE values or having negative tests for others.
Women of childbearing age must confirm they have started menstruating and have a negative urine pregnancy test before joining the study.
Women of childbearing age must agree to use a highly effective contraception method during the study and for 1 month after the study ends. These methods include hormonal contraception, intrauterine devices, male condoms, diaphragms with spermicide, sterilization methods, or sexual abstinence.
Participants must be able to follow the dosage schedule of the study medication.

Who Cannot Join the Study?

Patients who are not allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae cannot participate. These are types of dust mites.
Patients who do not have moderate-to-severe persistent rhinitis/rhinoconjunctivitis cannot participate. This means ongoing inflammation of the nose and eyes due to allergies.
Patients who do not have mild-to-moderate controlled allergic asthma cannot participate. This refers to asthma that is triggered by allergies and is managed with treatment.
Patients who are younger than 12 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Pwasiuegxqa Nnhjeg Sioxhf dqx Rrofkrn	Ibiza	Spain
Hrzhtznc Dt Lk Svuri Ceue I Sfas Ppe	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Portugal	Not yet recruiting	01.10.2025
Spain	Recruiting	01.10.2025

Trial locations

EP-088_MM09 is a special type of treatment designed to help people who are allergic to certain dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. This treatment is given as an injection under the skin. It works by using modified proteins from these dust mites to help the body become less sensitive to them over time. This can help reduce symptoms like sneezing, runny nose, and itchy eyes that are common in people with allergies to these dust mites. The goal of this treatment is to improve the quality of life for people who suffer from these allergies by making their symptoms less severe.

Allergic Rhinitis – Allergic rhinitis is an inflammation of the nasal passages caused by an allergic reaction to airborne substances, such as pollen, dust mites, or pet dander. It is characterized by symptoms such as sneezing, nasal congestion, runny nose, and itchy eyes. The condition can be seasonal, occurring at certain times of the year, or perennial, occurring year-round. Over time, exposure to allergens can lead to persistent symptoms and may affect daily activities and sleep. The inflammation can also extend to the eyes, causing allergic conjunctivitis, which results in red, itchy, and watery eyes.

Allergic Asthma – Allergic asthma is a type of asthma triggered by exposure to allergens like pollen, dust mites, or pet dander. It involves inflammation and narrowing of the airways, leading to symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The condition can be intermittent or persistent, with symptoms varying in severity. Over time, repeated exposure to allergens can lead to chronic inflammation and increased sensitivity of the airways. This can result in more frequent asthma attacks and a greater impact on daily activities. The condition often requires ongoing management to control symptoms and prevent exacerbations.

Trial ID:

2023-508548-23-00

Protocol code:

MM09-SIT-069

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?