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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on evaluating a new treatment for people suffering from allergic rhinitis or rhinoconjunctivitis, which are conditions that cause symptoms like a runny nose, sneezing, and itchy eyes due to allergies. The study is specifically for individuals who are allergic to house dust mites, which are tiny creatures found in household dust. The treatment being tested is a vaccine called Mannan-conjugated allergoid, 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 assess how effective and safe this vaccine is compared to a placebo, which looks like the real treatment but does not contain any active ingredients. Participants in the study will receive either the vaccine or the placebo over a period of time. The study will monitor how well the treatment works in reducing allergy symptoms and the need for other allergy medications. It will also look at the safety of the treatment by checking for any side effects.

Participants will be asked to keep track of their symptoms and any medications they take in a diary. The study will include people aged 12 to 65 who have moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. The trial aims to provide valuable information on whether this new vaccine can offer relief to those affected by house dust mite allergies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the clinical trial, the first step involves an initial visit to the study center. During this visit, eligibility is confirmed based on specific criteria, including age, medical history, and allergy tests.

    Participants are required to sign an informed consent form, indicating their understanding and agreement to participate in the study.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to evaluate the current state of the participant's allergic rhinitis or rhinoconjunctivitis. This includes recording symptoms and medication use over a specified period.

    Participants are instructed to maintain a diary, either electronic or paper, to log daily symptoms and any medications taken.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to receive either the active treatment or a placebo. The active treatment consists of a mannan-conjugated allergoid vaccine administered as a subcutaneous injection.

    The dosage for the active treatment is 3,000 mTU/mL. The frequency and duration of administration are determined by the study protocol and communicated during the trial.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor the participant's response to the treatment. These visits include assessments of symptoms, medication use, and any side effects experienced.

    Participants continue to record their symptoms and medication use in their diaries, which are reviewed during these visits.

  5. Step 5

    Final assessment

    At the end of the treatment period, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

    Participants complete questionnaires to assess their quality of life and control of symptoms, and any remaining study-related procedures are completed.

Who can join the trial?

11 criteria

  • Participants must sign and date an Informed Consent Form (ICF), 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 or 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 one year, with or without mild-to-moderate controlled asthma, caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
  • 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 (raised bump) of at least 5 mm in diameter to the allergens Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
  • Participants must have specific IgE (a type of antibody) against the allergens Dermatophagoides pteronyssinus and/or Dermatophagoides farinae with a value of at least 3.5 kU/L.
  • Participants should preferably be allergic only to the study allergens. If allergic to other substances, they must meet specific conditions regarding other allergens like Blomia tropicalis, Lepidoglyphus destructor, and 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 method of contraception during the study and for one month after the study ends. These methods include hormonal contraception, intrauterine devices, male condoms, or other reliable methods.
  • Participants must be able to follow the dosage schedule of the study medication.

Who cannot join the trial?

5 criteria

  • Patients who are not allergic to Dermatophagoides pteronyssinus 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. Asthma is a condition that affects the airways in the lungs, making it hard to breathe.
  • 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.
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Investigated drugs

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 your 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 make your allergic reactions less severe and improve your overall comfort and quality of life.

What is already known about the treatment

EP-088_MM09 – This medication is administered through an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials to assess its effectiveness and safety for treating moderate-to-severe allergic rhinitis or rhinoconjunctivitis, with or without mild-to-moderate controlled allergic asthma. The medication works by targeting specific allergens from dust mites, Dermatophagoides pteronyssinus and Dermatophagoides farinae, to help the immune system become less sensitive to these allergens. It is classified as an allergen immunotherapy, which aims to reduce allergic reactions over time.

Investigated diseases

  • Allergic Rhinitis

    Allergic rhinitis is an inflammation of the nasal passages caused by allergens such as pollen, dust mites, or pet dander. It is characterized by symptoms like sneezing, nasal congestion, runny nose, and itchy eyes. The condition can be seasonal or perennial, depending on the allergen. Over time, exposure to allergens can lead to persistent symptoms. The inflammation may also affect the eyes, leading to allergic conjunctivitis, which causes red, itchy, and watery eyes. Chronic exposure to allergens can exacerbate symptoms and lead to complications such as sinusitis or ear infections.

  • Allergic Asthma

    Allergic asthma is a type of asthma triggered by exposure to allergens like pollen, dust mites, or mold. 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 worsen the inflammation and increase the frequency of asthma attacks. The airways may become more sensitive, leading to increased reactivity to other triggers. Managing exposure to allergens is crucial to controlling symptoms and preventing exacerbations.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508547-51-00Protocol codeMM09-SIT-063Estimated enrolment250 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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