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Study on the Effectiveness and Safety of CLU-RX-DPT for Patients with Moderate-to-Severe House Dust Mite Allergy

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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 a condition known as allergic rhinitis, which is a type of allergy that affects the nose and eyes, often caused by house dust mites. The study aims to evaluate a treatment called subcutaneous cluster-immunotherapy, which involves injecting small doses of an allergen to help the body build up a tolerance. The treatment being tested is called CLU-RX-DPT, which comes in three different doses: low, mid, and high. These doses contain a modified form of the allergen from house dust mites, specifically Dermatophagoides pteronyssinus, which is a common cause of dust mite allergies.

The purpose of the study is to find the most effective and best-tolerated dose of CLU-RX-DPT for people with moderate-to-severe allergic rhinitis due to house dust mites. Participants in the study will receive either one of the doses of CLU-RX-DPT or a placebo, which looks and feels like the treatment but does not contain the active allergen. The study will monitor how well the treatment works in reducing allergy symptoms and the need for other allergy medications over a period of time.

Throughout the study, participants will be asked to keep track of their symptoms and any allergy medications they use. This information will help researchers understand how the treatment affects daily life and overall comfort. The study will also look at how the treatment impacts the quality of life for those with allergic rhinitis. The goal is to determine which dose of CLU-RX-DPT provides the best balance of benefits and side effects for managing symptoms of house dust mite allergies.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a history of moderate-to-severe allergic rhinitis or rhino-conjunctivitis due to house dust mites for at least one year.

    Eligibility is further confirmed through tests such as a skin prick test and serum allergen-specific IgE test.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of four groups: placebo, low dose, mid dose, or high dose of CLU-RX-DPT.

    The treatment involves a solution for injection administered through the skin (transdermal use).

  3. Step 3

    Treatment phase

    During the treatment phase, participants receive injections of the assigned dose of CLU-RX-DPT or placebo.

    The frequency and duration of the injections are determined by the study protocol, which aims to establish the most effective and best-tolerated dose.

  4. Step 4

    Symptom and medication tracking

    Participants are required to maintain an electronic diary to record symptoms and any use of rescue medication.

    This data contributes to the Combined Symptom and Medication Score (CSMS), which is used to evaluate the treatment's effectiveness.

  5. Step 5

    Evaluation of treatment efficacy

    The primary goal is to measure the differences in mean CSMS between the active treatment groups and the placebo group.

    Secondary evaluations include changes in symptom scores, quality of life assessments, and the percentage of symptom-free days.

  6. Step 6

    End of treatment assessment

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

    This includes a comparison of pre-treatment and post-treatment responses to nasal provocation tests.

Who can join the trial?

9 criteria

  • Patients must sign and date an informed consent form before any study-related examination. This means they agree to participate after understanding the study details.
  • Participants should be between 18 and 65 years old at the time of signing the consent form.
  • Patients must have had **moderate-to-severe allergic rhinitis** (a condition causing sneezing, stuffy or runny nose due to allergies) or **rhino-conjunctivitis** (allergy symptoms affecting the nose and eyes) caused by house dust mites for at least one year. This should be according to specific guidelines. They can have mild-to-moderate asthma that is well-controlled or no asthma at all.
  • For patients with asthma, their **forced expiratory volume (FEV1)**, which is the amount of air they can forcefully exhale in one second, should be more than 80% of the normal value expected for them.
  • Patients must show **sensitization to Dermatophagoides pteronyssinus**, a type of house dust mite. This is confirmed by a positive skin test and a specific blood test showing an allergy to this mite.
  • Participants should have a **Retrospective Rhinitis Total Symptom Score (RRTSS)** of 2 or more, based on the worst days during the previous winter. This score measures the severity of their symptoms.
  • Patients must respond positively to a nasal test with the dust mite allergen.
  • Participants should be able to understand and use an electronic diary to record their symptoms and any medication they take.
  • Patients must have laboratory test results that are normal or not considered significant if they are outside the normal range.

Who cannot join the trial?

4 criteria

  • Individuals who do not have moderate-to-severe allergic rhinitis or rhino-conjunctivitis caused by house dust mites for at least one year.
  • Individuals who do not meet the age requirements specified for the trial.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
  • Individuals who do not fit into the specified clinical trial groups.
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Investigated drugs

CLU-RX-DPT is a medication being tested in this clinical trial. It is used for subcutaneous cluster-immunotherapy, which means it is given as an injection under the skin. The goal of this therapy is to help patients who have allergies to house dust mites. The trial aims to find the most effective and safest dose of this medication, balancing the benefits and any potential risks.

What is already known about the treatment

CLU-RX-DPT – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials to determine its effectiveness and safety for treating moderate-to-severe allergic rhinitis or rhino-conjunctivitis caused by house dust mites. The main therapeutic indication is to alleviate symptoms associated with these allergies. At the molecular level, CLU-RX-DPT works by modulating the immune system's response to allergens, aiming to reduce sensitivity and improve tolerance. It is classified pharmacologically as an immunotherapy agent.

Investigated diseases

Allergic Rhinitis – Allergic rhinitis is a condition where the inside of the nose becomes inflamed due to an allergic reaction to airborne substances, such as pollen, dust mites, or pet dander. It is characterized by symptoms like sneezing, itching, nasal congestion, and runny nose. The condition can also affect the eyes, causing redness, itching, and watering, which is referred to as rhino-conjunctivitis. Symptoms can vary in severity and may be seasonal or year-round, depending on the allergens involved. Over time, exposure to allergens can lead to persistent symptoms and discomfort. Managing the environment to reduce exposure to allergens is often necessary to alleviate symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517014-15-00Protocol codeSC-3H2AEstimated enrolment832 patientsSponsorROXALL Medizin GmbH

sourced from the EU Clinical Trials Register and site verification

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