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Safety of a rush up‑dosing regimen of dust mite allergen extract versus conventional up‑dosing in adults with dust mite rhinitis/rhinoconjunctivitis with asthma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on adults who have Allergic House Dust Mite Rhinitis/Rhinoconjunctivitis, a condition that causes sneezing, a runny or blocked nose, itchy eyes and sometimes includes Asthma, which is a breathing problem that makes the airways narrow. The treatment being tested is an allergy injection called PURETHAL Mites Mixture 50,000 AUeq/mL, which contains tiny amounts of the dust‑mite proteins that trigger the allergic reaction.

The purpose of the study is to compare how safe the treatment is when given by a fast “rush up-dosing regimen” versus a slower “conventional up-dosing regimen”. Participants are randomly placed into one of the two groups and receive a series of injections. Each injection starts with a very small amount and the dose is increased step‑by‑step until a regular maintenance dose is reached.

During the study, participants will be observed for any side effects, called treatment‑emergent adverse events (a side effect that starts after the treatment begins). Early reactions that happen within 30 minutes, later reactions up to 24 hours, and any swelling or redness at the injection site are recorded. The goal is to see how many people experience at least one side effect with each dosing schedule and to assess how well the treatment is tolerated.

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

    Baseline Visit and Allergy Confirmation

    After joining the study, you attend the first study visit where the research team confirms your allergy to house dust mites.

    A skin prick test is performed using small drops of allergen solutions on your forearm. A tiny needle slightly pricks the skin to see if a reaction occurs, which helps verify the diagnosis.

    No study medication is given during this visit; it is only for assessment and documentation.

  2. Step 2

    Randomization to Treatment Regimen

    Based on the study design, you are randomly assigned to one of two dosing schedules: the rush up‑dosing regimen or the conventional up‑dosing regimen.

    The rush regimen delivers several injections over a short period (a few days), while the conventional regimen spreads the injections over several weeks.

  3. Step 3

    Up‑Dosing Phase – Receiving the Study Medication

    During the up‑dosing phase you receive the investigational product PURETHAL Mites Mixture 50,000 AUeq/mL.

    The product is administered as a subcutaneous injection (injection under the skin) of 0.5 ml per dose.

    The dose is increased according to the assigned schedule until the planned maintenance dose of 0.5 ml is reached.

    After each injection you are observed for at least 30 minutes for any immediate local or systemic reactions, and you are instructed to report any symptoms that appear up to 24 hours later.

  4. Step 4

    Maintenance Phase – Regular Injections

    Once the maintenance dose of 0.5 ml has been achieved, you continue to receive the same dose at regular intervals for the remainder of the trial.

    The exact interval (e.g., weekly or monthly) follows the study protocol and is the same for all participants regardless of the initial up‑dosing regimen.

  5. Step 5

    Periodic Safety and Tolerability Assessments

    During the study you attend scheduled clinic visits where the investigators check your health, record any adverse events, and ask you to complete simple questionnaires about how you feel.

    These visits may include a brief physical examination and, if needed, basic laboratory tests to ensure safety.

  6. Step 6

    Final Study Visit and Study Completion

    At the end of the study period you have a final visit where all remaining safety information is collected.

    The study team reviews the overall results, and you are thanked for your participation.

Who can join the trial?

9 criteria

  • Signed the current approved Informed Consent Form before any screening procedures.
  • Be between 18 and 65 years old at the time you sign the consent.
  • Have a history of allergic reactions to house dust mites that cause runny or itchy nose (and possibly asthma) for at least one year, as defined by the ARIA guidelines.
  • Be able and willing to fill out an electronic diary (e‑Diary) for 24 hours after each injection.
  • If you have asthma, it must be mild to moderate, well‑controlled for at least three months using inhaled steroid medicines and/or long‑acting bronchodilators (these are medicines that keep the airways open). The inhaled steroid dose must stay at or below the specified low‑dose limits (for example, ≤400 µg budesonide per day).
  • Show a positive skin prick test to dust‑mite allergens (Dermatophagoides pteronyssinus or D. farinae). This means a small bump (wheal) of at least 3 mm appears on the skin, while the control tests stay within normal limits.
  • Have a positive nasal provocation test to dust‑mite extract, meaning the test score (Lebel score) is 6 or higher when a standard amount of allergen is used. The test will be delayed if the initial score is 3 or higher or if the control reaction is unusually strong.
  • Have a measurable level of dust‑mite specific antibodies in the blood (serum IgE) that is greater than 0.7 U/mL.
  • For women who could become pregnant, a negative pregnancy test is required, and you must use a highly effective method of contraception (such as hormonal birth control, an intrauterine device, tubal ligation, a partner’s vasectomy, or agreed‑upon sexual abstinence) throughout the study.

Who cannot join the trial?

26 criteria

  • Nasal surgery or serious nose or mouth disease within the past 6 months makes you ineligible.
  • Any treatment that weakens the immune system (called immunosuppressive treatment) or therapy that blocks IgE antibodies within the past 6 months, and any use during the study, excludes participation.
  • Use of β‑adrenergic blockers (a type of blood‑pressure medicine) is not allowed unless a doctor decides the benefit outweighs the risk.
  • If you are allergic (have hypersensitivity) to any ingredient in the study drug, you cannot join.
  • Severe immune disorders, such as autoimmune diseases (where the body attacks itself), or any disease that needs immune‑weakening medication, are exclusion criteria.
  • Having an active, sudden lung infection (called an acute respiratory infection) within 2 weeks before screening disqualifies you.
  • Current cancer (active malignancy) or any cancer diagnosed in the last 5 years excludes you.
  • Any serious chronic or sudden illness that the doctor believes could add extra risk, including heart problems (cardiovascular insufficiency), severe lung disease, hormone (endocrine) disorders, serious kidney or liver disease, blood (haematological) disorders, severe eczema (atopic dermatitis), or skin conditions that would affect allergy skin testing, makes you ineligible.
  • Diseases that make using adrenaline (epinephrine) unsafe, such as overactive thyroid (hyperthyroidism) or glaucoma, are exclusion reasons.
  • Being unable to stop medications that are not allowed during the study period also excludes you.
  • Having moderate to severe blockage of the nose, such as nasal polyps or a deviated septum, prevents participation.
  • If you cannot use or complete the electronic diary (e‑Diary) required for the study, you are not eligible.
  • Significant long‑lasting sinus infection (chronic sinusitis) or eye infection excludes you.
  • Women who could become pregnant and are currently pregnant or breastfeeding (lactating) cannot join.
  • Any misuse of alcohol, illegal drugs, or prescription medication within the past year or during the trial disqualifies you.
  • If the investigator believes you may not cooperate or follow the study rules, you will be excluded.
  • Severe mental health conditions, including psychiatric, psychological, or neurological disorders, are exclusion criteria.
  • People who work for the study sponsor, the research organization, the trial site, or are close family members or partners of the investigators cannot participate.
  • Anyone who is under a legal order or commitment from a court or government authority is excluded.
  • Having severe asthma that requires the highest treatment steps (steps 4‑5 in the GINA 2025 guidelines) excludes you.
  • Uncontrolled asthma, defined as any of the following: asthma control test score ≤ 19, lung function (FEV1) ≤ 70% of expected, emergency room visit for asthma in the past 6 months, hospital stay for asthma in the past year, need for a breathing tube (intubation), more than two courses of oral steroids in the past 6 months, or using high‑dose inhaled steroids (> 400 µg budesonide or equivalent) daily, makes you ineligible.
  • A history of severe allergic reaction (anaphylaxis) with heart or breathing symptoms, from food, drugs, or unknown cause, excludes you.
  • If you received allergy immunotherapy (called AIT) with house‑dust‑mite (HDM) allergens or related allergens for more than one month at a maintenance dose within the past 5 years, you cannot join (starting new HDM therapy is allowed only if stopped before reaching the maintenance dose).
  • Using any other allergy immunotherapy (subcutaneous, sublingual, or oral) for different allergens within the past 3 months, or planning to use it during the study, excludes you.
  • Participation in another clinical trial within the past 3 months, or during this study, makes you ineligible.
  • Receiving any vaccination, including COVID‑19, less than one week before screening, during screening, or during the dose‑escalation phase, unless medically required, excludes you.
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Investigated drugs

HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Farinae
This is a tiny drop of liquid that is placed on the skin to test whether you react to dust‑mite allergens. A small prick is made through the drop, and the skin is observed for a reaction, helping doctors confirm if dust mites are causing your symptoms. HAL Allergy Prick Test Positieve Controle 10 mg/ml
This solution contains histamine, a substance that always causes a mild skin reaction. It is used during skin‑prick testing as a positive control to show that the test works correctly. HAL Allergy Prick Test Gräserpollen‑Mischung
This is a mixture of several grass pollen extracts applied to the skin in a prick test. It helps identify whether you are allergic to common grass pollens that can trigger hay fever or asthma. HAL Allergy Provo Spray, Provokationstestlösung, Nasenspray
This nasal spray contains dust‑mite allergen and is used to provoke a controlled allergic response in the nose. It allows the study team to see how your nose reacts to the allergen before starting treatment. HAL Allergy Pricktest Negativkontrolle, Pricktestlösung
This solution contains phenol, which does not cause an allergic skin reaction. It is used as a negative control during skin‑prick testing to confirm that any reaction seen is due to the allergen and not the testing process itself. HAL Allergy Prick Test Hundeepithelien
A small drop of dog‑skin protein is applied to the skin for a prick test. It helps determine whether you have an allergy to dog dander, which can contribute to nasal or respiratory symptoms. PURETHAL Mites 50.000 AUeq/mL
This is a sterile suspension that is injected under the skin and contains dust‑mite allergens. It is given in a series of increasing doses (up‑dosing) to gradually desensitize your immune system, reducing the severity of allergic rhinitis, conjunctivitis, or asthma caused by dust mites. HAL Allergy Prick Test Frühblühende Bäume Mischung I
This skin‑prick test solution contains extracts from early‑blooming tree pollens such as hazel, alder, and birch. It is used to find out if you are allergic to these tree pollens, which often cause seasonal allergy symptoms. HAL Allergy Prick Test Gemeiner Beifuß
A prick‑test drop that includes extract from common mugwort (a weed). It helps identify mugwort allergy, which can trigger respiratory or skin reactions. HAL Allergy Prick Test Aspergillus Fumigatus
This test solution contains mold (Aspergillus fumigatus) extract. It is applied to the skin to check for allergic reactions to this common indoor fungus. HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus
A skin‑prick test drop with the dust‑mite species Dermatophagoides pteronyssinus. It helps confirm whether this specific mite is a trigger for your allergic symptoms. HAL Allergy Prick Test Katzenepithelien
This solution contains cat‑skin proteins and is used in a skin‑prick test to see if you are allergic to cat dander, which can worsen nasal and breathing problems.

What is already known about the treatment

PURETHAL Mites 50.000 AUeq/mL - This medication is given as a 0.5 ml injection under the skin (subcutaneous use) and comes as a sterile suspension containing standardized extracts of the dust‑mite species Dermatophagoides pteronyssinus and Dermatophagoides farinae. It is an established allergen immunotherapy product that is widely used and described in medical literature for treating allergic house‑dust‑mite rhinitis or rhinoconjunctivitis, with or without asthma. The treatment works by slowly teaching the immune system to tolerate the mite allergens, shifting the reaction from an allergic (IgE‑driven) response to a more balanced, less‑reactive state. It is classified as a subcutaneous allergen immunotherapy (SCIT) preparation.

Investigated diseases

House dust mite–induced allergic rhinitis/rhinoconjunctivitis, with or without asthma - This condition is an allergic inflammation of the nasal passages and the lining of the eyes that occurs after exposure to proteins from house dust mites. People experience symptoms such as sneezing, nasal congestion, runny nose, itchy or watery eyes, and sometimes coughing or wheezing if the lower airways are involved. Repeated or continuous exposure can cause the symptoms to become more persistent and may lead to the development of asthma in some individuals. Symptoms often worsen during times of increased indoor mite exposure, such as in dusty or humid environments, and may improve when the trigger is reduced.
Trial detailsLast updated 20 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526908-72-00Protocol codePM/0062Estimated enrolment120 patientsSponsorHAL Allergy B.V.

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