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ALLERGEN EXTRACTS

Clinical trials are studying BLOMIA TROPICALIS POLYMERIZED EXTRACT as part of a vaccine for dust mite and Blomia tropicalis allergy. These studies look at safety and how well it works in people with moderate-to-severe allergic rhinitis/rhinoconjunctivitis, with or without mild-to-moderate controlled asthma.

Table of Contents

Trial overview

The available study is an interventional clinical trial, which means participants receive a study treatment and the results are compared with another group.[1] It is designed to assess the efficacy and safety of a vaccine for dust mite and Blomia tropicalis allergy.[1]

The trial is authorised and includes 120 participants.[1]

Who can join the study

The trial is for people aged 12 to 65 years who have moderate-to-severe persistent allergic rhinitis/rhinoconjunctivitis.[1] People may also have mild-to-moderate controlled allergic asthma, as long as it is controlled.[1]

This means the study is focused on patients with allergy problems that affect the nose and eyes, and in some cases the lungs as well.[1]

What is being tested

The study treatment is BLOMIA TROPICALIS POLYMERIZED EXTRACT as part of a suspension for injection given under the skin.[1] The active treatment contains D.pteronyssinus/D.farinae/B.tropicalis polymerized extracts 10,000 TU/mL, and it is compared with a placebo that has the same solution and presentation but no active ingredients.[1]

The trial is testing whether this investigational medicinal product can help as an aetiological treatment, meaning a treatment aimed at the cause of the allergy.[1]

Trial phase and status

This study is a Phase 3 trial.[1] Phase 3 trials are later-stage studies that usually look at how well a treatment works in a larger group of patients while continuing to watch safety.[1]

The current status is authorised.[1]

Outcomes measured

The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS).[1] This score combines how bad the symptoms are and how much medication is used, so researchers can judge overall control of the allergy.[1]

The score is measured over 4 weeks after one year of treatment, and it is recorded in the participant’s diary.[1]

Patient-friendly terms

  • Placebo means a look-alike treatment used for comparison, but it does not contain active ingredients.[1]
  • Subcutaneous injection means the treatment is given under the skin.[1]
  • Allergic rhinitis/rhinoconjunctivitis means allergy symptoms in the nose, and sometimes the eyes too.[1]
  • Controlled asthma means asthma that is stable and not badly affecting the person most of the time.[1]
  • Participant diary is the record used by the study volunteer to write down symptoms and other study information.[1]
Trial ID Phase Condition studied Status Enrollment
2025-522773-12-00 Phase 3 Moderate-to-severe allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate controlled allergic asthma Authorised 120

FAQ

  • Who can take part in trials of BLOMIA TROPICALIS POLYMERIZED EXTRACT? The trial data describe participants aged 12 to 65 years. They have moderate-to-severe persistent allergic rhinitis/rhinoconjunctivitis, with or without controlled mild-to-moderate asthma.
  • What is being studied in these trials? The study is testing BLOMIA TROPICALIS POLYMERIZED EXTRACT as part of a vaccine for dust mite and Blomia tropicalis allergy. It compares the active treatment with a placebo, which is a look-alike treatment without active ingredients.
  • What phase is the trial? The trial is a Phase 3 study. Phase 3 trials usually test how well a treatment works and continue to monitor safety in a larger group of people.
  • What condition is the trial focused on? It is focused on the aetiological treatment of allergic rhinitis/rhinoconjunctivitis. This means the study is looking at treatment that targets the cause of the allergy, not only the symptoms.
  • What outcome is the trial measuring? The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score, also called RCSMS. This score is checked over 4 weeks after one year of treatment using the participant’s diary.

Ongoing Clinical Trials on ALLERGEN EXTRACTS

  • Clinical Trial of Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Blomia tropicalis Allergen Extracts in Patients with Allergic Rhinitis/Rhinoconjunctivitis With or Without Mild Asthma

    Not yet recruiting

    3 1
    Investigated drugs:
    Spain

Glossary

  • Allergic rhinitis: Nasal allergy that can cause sneezing, runny nose, and blocked nose.
  • Rhinoconjunctivitis: Allergy that affects both the nose and the eyes.
  • Asthma: A long-term lung condition that can cause wheezing, cough, and shortness of breath.
  • Controlled asthma: Asthma that is kept stable and not causing major symptoms most of the time.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and keeps checking safety.
  • Placebo: A look-alike treatment without active ingredients, used for comparison in a trial.
  • Subcutaneous: Given by injection under the skin.
  • Investigational medicinal product (IMP): The study treatment being tested in a clinical trial.
  • Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS): A score that combines allergy symptoms and medication use to show how well treatment is working.
  • Participant diary: A record kept by the person in the study to note symptoms, medicines, or other study information.

References

  1. https://clinicaltrials.gov/study/2025-522773-12-00