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Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Lepidoglyphus destructor Immunotherapy for Allergic Rhinitis and Rhinoconjunctivitis in Patients With or Without Mild 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 studying allergic rhinitis/rhinoconjunctivitis, which means long-lasting allergy symptoms in the nose and eyes, with or without mild asthma. The allergy is caused by dust mites and Lepidoglyphus destructor, a type of tiny insect found in dust and stored grains. The treatment being tested is an allergy injection containing modified extracts from Dermatophagoides pteronyssinus, Dermatophagoides farinae, and Lepidoglyphus destructor. The purpose of the study is to see whether this treatment is safe and helps reduce allergy symptoms better than a placebo.

People in the study are assigned by chance to receive either the active injection or placebo, and neither the participants nor the study team know which one is given. The treatment is given under the skin over a period of time. During the study, allergy and asthma symptoms, use of allergy or asthma medicines, and possible side effects are followed over about one year of treatment.

The study includes people with moderate to severe allergy symptoms, with or without controlled mild asthma. It is designed to learn whether this form of immunotherapy, a treatment that helps the body become less sensitive to an allergen, can improve day-to-day symptoms and safety in people allergic to these dust-related allergens.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and assignment

    After joining the study, you are assigned in a random way to receive either the investigational treatment or a placebo. A placebo is a solution with the same appearance and presentation as the active treatment, but without active ingredients.

    The study is double-blind, which means that neither you nor the study staff know which treatment you receive during the trial.

  2. Step 2

    Treatment administration

    You receive the study treatment by subcutaneous injection, which means an injection given under the skin.

    The active treatment is Dermatophagoides/L. destructor 30,000/30,000 TU/mL suspension for injection. The dose is 0.5 ml each time it is given.

    The treatment contains allergen extracts from Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Lepidoglyphus destructor. These are substances related to dust mite allergy and storage mite allergy.

    If you are assigned to placebo, you receive the same solution and presentation as the active treatment, but without active ingredients.

    The trial lasts for about one year of treatment, and the main symptom and medicine results are assessed over the 4 weeks after one year of treatment.

  3. Step 3

    Recording symptoms and medicine use

    You record your symptoms and medicine use in the participant's diary.

    The main result is the rhinoconjunctivitis combined symptom and medication score. Rhinoconjunctivitis means nose and eye allergy symptoms.

    Other scores may also be recorded during the trial, including scores for rhinitis/rhinoconjunctivitis symptoms and medicine use. Rhinitis means inflammation of the nose.

    If you have asthma, additional scores may be recorded for asthma symptoms and asthma medicine use.

  4. Step 4

    Follow-up assessments during the trial

    During the trial, your symptoms, medicine use, and overall health are checked. This includes allergy symptoms, asthma symptoms if present, and any changes in how you feel.

    The trial also measures whether you have any asthma worsening episodes, including the time until the first episode, how many happen, how long they last, and how severe they are.

    Your quality of life may be assessed with questionnaires about asthma and allergy symptoms.

    Your asthma control may be checked with the ACQ-6, which is a short questionnaire about how well asthma is controlled.

    Your symptoms may also be rated on a visual analogue scale, which is a line or scale used to show how strong symptoms are.

  5. Step 5

    Safety monitoring

    Your safety is monitored throughout the trial.

    The study records any adverse events, which means unwanted medical problems that happen during the trial, and notes how serious they are.

    Reactions at the injection site are checked, as well as systemic reactions, which means reactions that affect the whole body.

    Any medicine used to treat a reaction is also recorded.

  6. Step 6

    Blood and allergy testing

    The trial may include tests of your blood and allergy markers.

    These tests may measure total IgE, specific IgE, IgG4, and the ratio of specific IgE to total IgE. IgE is a type of antibody linked to allergy.

    Allergen profiling may also be performed using the ALEX technique, which is a test that checks allergy responses to different allergens.

  7. Step 7

    End of treatment assessment

    After about one year of treatment, your symptoms and medicine use are reviewed over the following 4 weeks.

    At this stage, the main outcome is the rhinoconjunctivitis combined symptom and medication score recorded in your diary.

    Other symptom scores, asthma measures, quality of life questionnaires, and safety checks may also be reviewed at this time.

Who can join the trial?

20 criteria

  • Must have signed the informed consent form, which means agreeing to take part after the study has been explained.
  • Must be able to follow the dosing schedule, meaning they can take the study treatment as planned.
  • Must be able to record symptoms and medicine use in an electronic diary on a smartphone, or in a paper diary if needed.
  • Must have a Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) of at least 2 out of 6 for at least 10 days. This score measures allergy symptoms together with allergy medicine use.
  • Must be a male or female between 12 and 65 years old, including both ages.
  • Must have a confirmed history of allergy from inhaled substances with moderate-to-severe persistent rhinitis/rhinoconjunctivitis for at least 1 year. Rhinitis/rhinoconjunctivitis means ongoing nasal and eye allergy symptoms.
  • May have mild-to-moderate asthma only if it is controlled, meaning symptoms are well managed and not worsening.
  • The allergy must be caused by Dermatophagoides pteronyssinus, Dermatophagoides farinae, and/or Lepidoglyphus destructor, which are types of house dust mites.
  • Must have a positive skin prick test to standardized extracts of the dust mites listed above. A skin prick test is a small skin test that checks for allergy. The skin reaction, called a wheal or raised bump, must be at least 5 mm wide and at least as large as the reaction to histamine, which is the positive control used in the test.
  • Must have specific IgE of at least 3.5 kU/L to a complete extract or molecular part of the dust mites listed above. IgE is an allergy antibody in the blood, and a higher level can show allergy sensitivity.
  • If allergic to other airborne allergens, such as animal dander or pollen, the person may only join if all extra conditions are met.
  • If the person has a positive skin prick test to animal dander, they may join only if exposure is occasional and related symptoms happen only sometimes. If they are regularly exposed to animals or live with animals, the skin prick test to animal dander must be negative.
  • If the person is sensitive to pollen, the first symptom and medicine recording period must be done outside the pollen season, and must begin at least 1 month before or 1 month after the pollen season.
  • If the timing rules for pollen are not met at the baseline visit, the person cannot enter the study at that time.
  • If the person is sensitive to pollen, the final symptom and medicine recording period must also be done outside the pollen season and follow the same timing rules.
  • Whether pollen timing is acceptable will be checked using the local pollen calendar, which tracks pollen seasons in the area.
  • Must have a negative skin prick test to molds, meaning no allergy reaction to mold in that test.
  • If the participant is a woman who can become pregnant, she must have started menstruation and have a negative urine pregnancy test when entering the study.
  • If the participant is a woman who can become pregnant, she must agree to use a highly effective birth control method during the study and for 1 month after treatment ends.
  • Acceptable birth control methods include combined hormonal contraception (birth control with estrogen and progestogen), hormonal contraception that prevents ovulation taken by mouth, placed in the vagina, or worn on the skin, progestogen-only contraception that prevents ovulation by mouth, injection, or implant, intrauterine device (IUD), hormone-releasing intrauterine system (IUS), male condom, bilateral tubal occlusion (blocking both fallopian tubes), partner vasectomy, or sexual abstinence.

Who cannot join the trial?

26 criteria

  • Anyone who has had allergen immunotherapy for the study allergens in the last 5 years, or who is still receiving immunotherapy for any allergen, cannot take part. Immunotherapy means treatment with small amounts of an allergen to reduce allergy symptoms over time.
  • Anyone who had a respiratory tract infection or an asthma flare-up in the 4 weeks before the screening visit cannot take part. A respiratory tract infection is an infection of the airways, and a flare-up means asthma symptoms suddenly became worse.
  • Anyone with a history of chronic urticaria (long-lasting hives), severe anaphylaxis (a very serious allergic reaction), or hereditary angioedema (inherited swelling episodes) in the last 2 years cannot take part.
  • Anyone for whom adrenaline cannot be used safely cannot take part. This includes people with conditions such as hyperthyroidism (an overactive thyroid), heart disease, or high blood pressure, if the study doctor believes adrenaline would be unsafe.
  • Anyone with another serious illness not related to the allergy or asthma that could affect the study, such as epilepsy (seizures) or kidney disease, cannot take part.
  • Anyone with an uncontrolled autoimmune disease cannot take part. An autoimmune disease is when the body's defense system attacks its own tissues. Examples include thyroiditis (thyroid inflammation) and lupus.
  • Anyone with a tumor-related disease or an immunodeficiency (a weak immune system) cannot take part.
  • Anyone who is unlikely to follow the study plan, or who has a serious mental illness, cannot take part.
  • Anyone with a known allergy to any part of the study medicine, other than the study allergens, cannot take part.
  • Anyone with another lung disease besides asthma, such as emphysema (damaged air sacs in the lungs), bronchiectasis (widened airways with mucus build-up), or chronic obstructive pulmonary disease (COPD) (long-term airflow blockage), cannot take part.
  • Anyone who has taken medicines that can affect skin prick test results, such as antihistamines (allergy medicines), within the required time before testing cannot take part.
  • Anyone with a nasal problem that could affect study results, such as nasal polyps (soft growths inside the nose) or non-allergic rhinitis (nose inflammation not caused by allergy), cannot take part.
  • Anyone who has had another desensitization procedure, such as oral immunotherapy (allergen taken by mouth to reduce sensitivity), cannot take part unless they have been in the maintenance phase for at least 12 months. Maintenance phase means the stable long-term treatment phase.
  • Anyone who needs regular antihistamines or corticosteroids for reasons other than allergy symptom relief cannot take part, except for short use of up to 15 days for a common cold. Corticosteroids are medicines that reduce inflammation.
  • Pregnant women and women who are breastfeeding cannot take part.
  • Immediate family members of the investigator cannot take part.
  • Anyone who is taking part in another clinical trial now, or who took part in another trial within 30 days before screening, cannot take part.
  • Anyone with a history of severe whole-body allergic reactions, including reactions to foods, insect venom, or medicines, cannot take part.
  • Anyone with cancer, whether controlled or uncontrolled, cannot take part.
  • Anyone for whom allergen-specific immunotherapy is absolutely not allowed, according to allergy treatment guidelines, cannot take part.
  • Anyone with uncontrolled or partially controlled asthma cannot take part. Controlled means symptoms are kept under good control; partially controlled means not fully controlled.
  • Anyone with FEV₁ below 80% of the expected value cannot take part, even with treatment. FEV₁ is the amount of air a person can blow out in 1 second.
  • Anyone with severe asthma who needs Step 5 or Step 6 treatment cannot take part. These are higher-intensity asthma treatment levels.
  • Anyone taking beta-blockers by mouth or injection, or ACE inhibitors (blood pressure medicines), cannot take part. Topical beta-blockers applied on the skin are allowed.
  • Anyone taking immunosuppressive drugs (medicines that lower the immune response), except topical forms, or biological therapies (targeted medicines made from living cells), cannot take part.
  • Anyone who needs regular systemic corticosteroids (steroids taken by mouth or injection) for rhinitis, rhinoconjunctivitis, or asthma cannot take part. Regular use of inhaled, skin, or local corticosteroids for these conditions, and for atopic dermatitis, is allowed.
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Investigated drugs

Dermatophagoides/L. destructor allergen extract: This is the study treatment being tested in the trial. It is an allergy immunotherapy made from extracts of house dust mites and storage mites, used to help the body become less sensitive to these allergens over time. It is given as an injection under the skin. The goal of this treatment is to reduce symptoms of allergic rhinitis/rhinoconjunctivitis, and in some participants it may also help with mild to moderate asthma symptoms linked to these allergies.

What is already known about the treatment

  • Dermatophagoides/L. destructor 30,000/30,000 TU/mL suspension for injection

    This medicine is given as a subcutaneous injection, meaning it is injected under the skin by a healthcare professional as part of allergy immunotherapy. It is an allergen extract used in medicine and medical research to help reduce allergic reactions over time, and it is mainly studied for people with allergic rhinitis, eye-nose allergy symptoms, and mild to moderate controlled allergic asthma caused by house dust mites and Lepidoglyphus destructor. At the molecular level, it works by exposing the immune system to small, carefully prepared amounts of the allergen so the body becomes less sensitive to it and makes fewer allergy-triggering signals. It belongs to the pharmacological group of allergen extracts used for desensitization treatment.

  • Placebo

    This is a matching solution with the same appearance and presentation as the active treatment, but it does not contain any active allergy ingredients. It is given in the same way as the study medicine so that results can be compared fairly in the clinical trial. A placebo has no direct therapeutic effect on allergy symptoms and is used only for research purposes to measure the true effect of the active medicine. It does not belong to a pharmacological treatment class because it contains no active substance.

Investigated diseases

  • Allergic rhinitis

    Allergic rhinitis is inflammation of the lining of the nose caused by an allergic reaction, often triggered by substances such as house dust mites. It usually causes repeated sneezing, a runny or blocked nose, and itching. The condition may be persistent and can vary in severity over time, with symptoms often becoming worse when exposure to the trigger continues.

  • Allergic rhinoconjunctivitis

    Allergic rhinoconjunctivitis is an allergic condition that affects both the nose and the eyes. It commonly causes nasal symptoms together with red, itchy, watery eyes. The disorder may develop with ongoing exposure to allergens and can remain mild or become more persistent and troublesome.

  • Allergic asthma

    Allergic asthma is a form of asthma in which the airways become sensitive to allergens and narrow in response to them. It can cause wheezing, cough, chest tightness, and shortness of breath. The condition may come and go or remain ongoing, and symptoms can gradually worsen when allergen exposure continues.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522771-28-00Protocol codeMM13-SIT-078Estimated enrolment120 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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