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

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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 studying the effectiveness and safety of a new treatment for people with allergies to house dust mites, specifically those who experience symptoms of allergic rhinitis or rhinoconjunctivitis, which may also be accompanied by mild to moderate asthma. The treatment being tested is called Clustoid MM09, which is a type of vaccine given as an injection under the skin. This vaccine contains modified extracts from two common dust mites, Dermatophagoides pteronyssinus and Dermatophagoides farinae, which are known to trigger allergic reactions in some people.

The purpose of the study is to evaluate how well this vaccine works in reducing allergy symptoms and the need for medication in people who are allergic to these dust mites. Participants in the study will receive either the Clustoid MM09 vaccine or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for up to 12 months, during which participants will receive regular injections and will be monitored for any changes in their allergy symptoms and overall health.

Throughout the study, participants will be asked to keep track of their symptoms and any medications they take using a smartphone app. The study aims to provide valuable information on the potential benefits of the Clustoid MM09 vaccine for people with dust mite allergies, potentially leading to improved treatment options for those affected by these common allergens.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Visit and Screening

    Upon joining the study, the initial visit involves a comprehensive screening process. This includes confirming eligibility based on age, medical history, and specific allergy tests.

    A skin prick test is conducted to confirm sensitivity to dust mites, Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. A specific IgE test is also performed to measure the level of allergy-related antibodies in the blood.

  2. Step 2

    Baseline Assessment

    A baseline assessment is conducted to evaluate current symptoms and medication use. This includes recording rhinitis/rhinoconjunctivitis and asthma symptoms.

    Participants are required to use a smartphone to log symptoms and medication intake throughout the trial.

  3. Step 3

    Randomization and Treatment Initiation

    Participants are randomly assigned to receive either the active treatment or a placebo. The active treatment is a subcutaneous injection of Clustoid MM09, a suspension for injection containing modified allergen extracts.

    The injections are administered subcutaneously, meaning they are given under the skin.

  4. Step 4

    Treatment Phase

    During the treatment phase, participants receive regular injections. The frequency and dosage are determined by the study protocol and are adjusted based on individual response and tolerance.

    Participants continue to record symptoms and medication use, which helps in assessing the treatment's effectiveness.

  5. Step 5

    Follow-up Visits

    Regular follow-up visits are scheduled to monitor health status, evaluate any side effects, and adjust treatment if necessary.

    These visits include assessments of symptom scores, medication use, and quality of life using standardized questionnaires.

  6. Step 6

    Final Assessment

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

    This includes a comprehensive review of symptom scores, medication use, and any changes in quality of life.

Who can join the trial?

11 criteria

  • Subjects who have signed the informed consent form, which means they agree to participate in the study after understanding what it involves.
  • Subjects diagnosed with asthma according to GEMA 5.0, a guideline for asthma management.
  • Subjects able to follow the dosing schedule, meaning they can take the medication as instructed.
  • Subjects owning a smartphone to record symptoms and medication use.
  • Subjects of both sexes aged between 12 and 65 years old.
  • Subjects with a confirmed clinical history of inhalant allergy, which includes moderate to severe rhinitis (inflammation of the nose) or rhinoconjunctivitis (inflammation of the nose and eyes) with or without controlled mild to moderate asthma, caused by an allergy to specific dust mites.
  • Subjects who have had a positive skin prick test result, which is a test to check for allergies, showing a reaction of 5 mm or larger for specific dust mites.
  • Subjects with a specific IgE value greater than 3.5 KU/L, which is a blood test that measures the level of allergy antibodies, for specific dust mites.
  • Subjects should preferably be allergic only to the study allergens. If they are allergic to other airborne allergens, they must meet certain conditions, such as having a positive skin test to specific allergens with certain IgE values or having a negative skin test for fungi.
  • Women of childbearing age should have a negative urine pregnancy test before starting the trial.
  • Women of childbearing potential should agree to use an effective method of contraception during the trial if they are sexually active.

Who cannot join the trial?

8 criteria

  • Patients with severe health conditions that are not related to allergies or asthma.
  • Individuals who have had a recent severe allergic reaction that required emergency treatment.
  • People who are currently participating in another clinical trial.
  • Patients who have a history of severe side effects from allergy treatments.
  • Individuals with uncontrolled asthma, meaning their asthma symptoms are not well-managed.
  • Pregnant or breastfeeding women.
  • Patients with other significant medical conditions that could interfere with the study.
  • Individuals who are unable to follow the study procedures or attend scheduled visits.
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Investigated drugs

Polymerised Allergen Extracts are used in this trial to help patients who have allergies to dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. These extracts are given through injections under the skin. The goal is to see if these allergen extracts can reduce symptoms of rhinitis or rhinoconjunctivitis, which are conditions that cause sneezing, runny nose, and itchy eyes. The trial also looks at whether these extracts can help people who have mild to moderate asthma along with their allergies.

What is already known about the treatment

Polymerised Allergen Extracts – This medication is administered through subcutaneous injections and is currently being studied in clinical trials for its effectiveness and safety. It is primarily used for treating moderate to severe intermittent or persistent allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma. The medication works by gradually desensitizing the immune system to specific allergens, such as those from dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae, thereby reducing allergic reactions. It falls under the pharmacological classification of immunotherapy agents.

Investigated diseases

  • Allergic Rhinitis

    This condition is characterized by inflammation of the nasal passages due to an allergic reaction. It often results in symptoms such as sneezing, itching, nasal congestion, and runny nose. The condition can be intermittent or persistent, depending on the frequency and duration of exposure to allergens. Allergic rhinitis can significantly impact daily activities and quality of life. It is commonly triggered by allergens like pollen, dust mites, or pet dander. The severity of symptoms can vary from mild to severe.

  • Allergic Rhinoconjunctivitis

    This disease involves inflammation of both the nasal passages and the conjunctiva of the eyes due to allergens. Symptoms include itchy, watery eyes, sneezing, nasal congestion, and a runny nose. It can be seasonal, often related to pollen, or perennial, due to indoor allergens like dust mites. The condition can affect daily activities and sleep quality. It is often associated with other allergic conditions such as asthma. The severity of symptoms can range from mild to severe.

  • Allergic Asthma

    This type of asthma is triggered by allergens such as pollen, dust mites, or pet dander. It causes symptoms like wheezing, coughing, shortness of breath, and chest tightness. The condition can be intermittent or persistent, with symptoms varying in intensity. Allergic asthma often coexists with other allergic conditions like rhinitis. It can affect physical activities and overall quality of life. The severity of asthma symptoms can fluctuate based on exposure to allergens.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514090-21-00Protocol codeMM09-SIT-023Estimated enrolment150 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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