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Study on the Safety and Effectiveness of Subcutaneous Immunotherapy with Der p 1, Der p 2, and Der p 23 Allergens for Patients with Allergic Rhinitis or Rhinoconjunctivitis

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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 effects of a treatment for people with allergic rhinitis or rhinoconjunctivitis, which are conditions that cause symptoms like sneezing, runny nose, and itchy eyes. These conditions are often triggered by allergies to dust mites, specifically the Dermatophagoides species. Some participants may also have allergic asthma, a type of asthma that is influenced by allergies. The treatment being tested is a form of immunotherapy, which involves injecting small amounts of allergens under the skin to help the body build up a tolerance over time. The allergens used in this study are purified forms of Der p 1, Der p 2, and Der p 23, which are proteins found in dust mites.

The purpose of the study is to evaluate the safety and effectiveness of this immunotherapy treatment. Participants will receive injections of the allergens at different doses, and some will receive a placebo. The study will last for a period during which participants will receive 12 maintenance doses. Throughout the study, participants will be monitored to see how their symptoms change and to ensure the treatment is safe. The study aims to find the optimal dose that provides the best balance of benefits and risks.

Participants will be assessed on various factors, including changes in their symptoms, medication use, and quality of life. The study will also look at how well the treatment helps control asthma symptoms for those who have it. Regular check-ups will be conducted to track progress and any side effects. The ultimate goal is to determine if this immunotherapy can effectively reduce symptoms and improve the quality of life for people with these allergic conditions.

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

    Joining the study

    Upon joining the study, you will be asked to sign an informed consent form. This document confirms that you understand the study and agree to participate.

    You will need to meet certain criteria, such as being between 12 and 65 years old and having a history of moderate to severe allergic rhinitis or rhinoconjunctivitis, possibly with controlled allergic asthma.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes a skin prick test to check for allergies to specific substances, such as Der p 1, Der p 2, or Der p 23.

    A blood test will be performed to measure specific allergy-related proteins, known as IgE levels.

  3. Step 3

    Treatment phase

    You will receive subcutaneous injections, which means the medication is injected under the skin. The treatment involves a combination of Der p 1, Der p 2, and Der p 23 allergens.

    The injections will be administered at different doses to determine the most effective dose. You will receive a total of 12 maintenance doses over the course of the study.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your symptoms and any medication use will be monitored. This includes regular assessments of your allergic rhinitis or rhinoconjunctivitis symptoms.

    You will be asked to report any changes in your symptoms and any side effects you experience. This helps evaluate the safety and effectiveness of the treatment.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment will be conducted. This includes repeating the skin prick test and blood tests to measure changes in your allergy-related proteins.

    The results will help determine the overall benefit and risk of the treatment and identify the optimal dose for future use.

Who can join the trial?

10 criteria

  • Patients or their legal representatives must have understood and signed the informed consent or assent form.
  • Patients must be between 12 and 65 years old.
  • Patients must have moderate or severe persistent allergic rhinitis or rhinoconjunctivitis for at least the last year. This means they have ongoing symptoms like a runny or stuffy nose, sneezing, or itchy eyes due to an allergy to dust mites from the Dermatophagoides genus.
  • Patients must have a clinical history showing symptoms of allergy to Dermatophagoides dust mites.
  • Patients must have a positive skin prick test. This is a test where a small amount of allergen is placed on the skin to see if there is a reaction, like a small bump, which should be at least 3 mm larger than the negative control.
  • Patients must have a specific IgE level of at least 0.7 kU/L. IgE is a type of antibody that the body makes in response to allergens.
  • Patients must have a positive CFP test to the mixture of purified allergens from Dermatophagoides dust mites.
  • Asthmatic patients must have a forced expiratory volume in the first second (FEV1) of at least 80%. This is a measure of how much air a person can forcefully exhale in one second and is used to assess lung function.
  • Women of childbearing age must have a negative urine pregnancy test and agree to use an effective method of contraception from 14 days before the first dose until 30 days after the last dose of the study drug.
  • Patients must be willing to follow all study procedures and be available for follow-up throughout the study.

Who cannot join the trial?

7 criteria

  • Patients with **uncontrolled asthma** cannot participate. This means if your asthma is not well-managed with your current treatment, you may not be eligible.
  • Patients who have had a **severe allergic reaction** to any of the study medications in the past cannot participate. A severe allergic reaction is a serious response by your body to a substance, which can include symptoms like difficulty breathing or swelling.
  • Patients with any other **serious health conditions** that might interfere with the study cannot participate. This includes conditions that require ongoing treatment or monitoring.
  • Patients who are currently participating in another clinical trial cannot participate. This is to ensure that the results of this study are not affected by other treatments.
  • Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
  • Patients who have a history of **drug or alcohol abuse** cannot participate. This means if you have had problems with excessive use of drugs or alcohol in the past, you may not be eligible.
  • Patients who have received any other **allergy immunotherapy** within the last 12 months cannot participate. Allergy immunotherapy is a treatment that helps your body get used to allergens, the things that cause your allergies.
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Investigated drugs

  • Der p 1

    is a type of allergen used in this clinical trial. It is derived from dust mites, which are tiny creatures found in household dust. People who are allergic to dust mites may experience symptoms like sneezing, runny nose, or itchy eyes. This medication is used in the trial to help the body build a tolerance to dust mite allergens, potentially reducing allergic reactions over time.

  • Der p 2

    is another allergen from dust mites included in the trial. Similar to Der p 1, it is used to help people with dust mite allergies. By exposing the body to small amounts of this allergen, the therapy aims to train the immune system to react less severely, which may help alleviate symptoms of allergic rhinitis or asthma.

  • Der p 23

    is also an allergen from dust mites used in the study. It works alongside Der p 1 and Der p 2 to help reduce allergic reactions. The goal of using these allergens is to gradually desensitize the immune system, so it becomes less sensitive to dust mites, potentially improving the quality of life for people with dust mite allergies.

What is already known about the treatment

Subcutaneous Immunotherapy with Purified Der p 1/Der p 2/Der p 23 Allergens – This medication is administered through injections under the skin, known as subcutaneous immunotherapy. It is currently being studied in clinical trials to assess its safety and effectiveness for treating moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without controlled allergic asthma, caused by sensitivity to dust mites from the Dermatophagoides genus. The main therapeutic use is to reduce allergic symptoms by gradually desensitizing the immune system to these allergens. At the molecular level, it works by modifying the immune response to allergens, potentially reducing the severity of allergic reactions over time. This medication falls under the pharmacological classification of allergen immunotherapy.

Investigated diseases

  • 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 itching. 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. Chronic exposure to allergens may worsen 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, mold, 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 vary in severity and may be influenced by environmental factors and allergen exposure. Over time, repeated exposure to allergens can lead to chronic inflammation and increased sensitivity of the airways. This can result in more frequent and severe asthma attacks. Managing allergen exposure is crucial to controlling symptoms and preventing exacerbations.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518519-20-01Protocol codeDIA-EC-MOLMite-01-24Estimated enrolment160 patientsSponsorDiater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

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