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ALLERGEN EXTRACTS

Clinical trials are studying BLOMIA TROPICALIS POLYMERIZED EXTRACT in people with dust mite and Blomia tropicalis allergy. The main goal is to check whether the treatment is effective and safe for allergic rhinitis/rhinoconjunctivitis, with or without mild asthma, in patients aged 12 to 65 years.

Table of contents

Trial overview

This clinical trial is studying BLOMIA TROPICALIS POLYMERIZED EXTRACT as an investigational treatment for allergy related to dust mites and Blomia tropicalis.[1]

The study is designed to assess both efficacy and safety, which means researchers want to know whether the treatment helps and whether it can be used safely in the study group.[1]

Who can participate

The trial is for people aged 12 to 65 years with moderate-to-severe persistent allergic rhinitis/rhinoconjunctivitis.[1]

Some participants may also have controlled intermittent or persistent mild-to-moderate allergic asthma.[1]

In simple terms, this means the study includes teenagers and adults who have stronger allergy symptoms, and some may also have asthma that is not severe and is kept under control.[1]

What is being tested

The active study treatment is a subcutaneous suspension for injection at 10,000 TU/mL, given in a 0.5 mL dose.[1]

The trial compares this active treatment with a placebo, which is a look-alike treatment without active ingredients.[1]

This kind of comparison helps researchers see whether improvements are due to the study treatment and not to chance or expectations alone.[1]

Trial phase and status

This is a Phase 3 study.[1]

Phase 3 trials are later-stage studies that usually include more people and focus on how well a treatment works while continuing to collect safety data.[1]

The trial status is Authorised, and the planned enrollment is 120 participants.[1]

Outcomes being measured

The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS).[1]

This score combines allergy symptoms and medication use, so it gives a fuller picture of how the treatment affects daily life.[1]

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

What the results may mean

If the active treatment performs better than placebo on the main outcome, it may suggest that the study treatment helps reduce allergy symptoms and medication needs in this patient group.[1]

Because the trial includes people with both rhinitis/rhinoconjunctivitis and some with controlled asthma, the results may be relevant to patients who have more than one allergy-related condition.[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 join trials of BLOMIA TROPICALIS POLYMERIZED EXTRACT? The trial data describe people aged 12 to 65 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis. Some participants may also have mild-to-moderate controlled allergic asthma.
  • What condition is being studied? The trial is studying aetiological treatment, which means treatment aimed at the cause of the allergy, for dust mite and Blomia tropicalis allergy. The main condition is persistent allergic rhinitis/rhinoconjunctivitis, with or without asthma.
  • What phase is the trial? This study is a Phase 3 trial. Phase 3 trials usually test how well a treatment works and continue to monitor safety in a larger group of people.
  • What is the trial comparing? The active treatment is compared with placebo, which is a look-alike treatment without active ingredients. This helps researchers see whether the study treatment gives better results than no active treatment.
  • What outcome is the trial measuring? The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score, or RCSMS. This score looks at both allergy symptoms and the need for medication over 4 weeks after one year of treatment.

Igangværende kliniske forsøg for ALLERGEN EXTRACTS

  • Allergivaccination med Dermatophagoides farinae, Dermatophagoides pteronyssinus og Blomia tropicalis til patienter med allergisk rhinitis/rhinokonjunktivitis med eller uden mild til moderat astma

    Rekrutterer endnu ikke

    1 1
    Undersøgte lægemidler:
    Spanien

Ordliste

  • Allergic rhinitis: A long-lasting nose allergy that can cause sneezing, a runny nose, and blocked nose.
  • Rhinoconjunctivitis: Allergy symptoms that affect both the nose and the eyes.
  • Asthma: A condition that makes the airways in the lungs narrow and can cause wheezing, cough, and shortness of breath.
  • Controlled asthma: Asthma that is kept stable and does not cause major problems most of the time.
  • Moderate-to-severe: A level of illness that is more than mild and can cause clear daily symptoms or discomfort.
  • Phase 3: A later stage of clinical research where a treatment is tested in a larger group to learn more about how well it works and how safe it is.
  • Placebo: A treatment that looks like the study medicine but does not contain the active ingredients.
  • Subcutaneous: Given by injection under the skin.
  • Primary outcome: The main result the researchers plan to measure to see if the trial works.
  • RCSMS: Short for Rhinoconjunctivitis Combined Symptom and Medication Score. It combines allergy symptoms and medication use into one score.
  • Participant diary: A record kept by the study participant to note symptoms, medication use, or other trial information.

Referencer

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