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Dermatophagoides Pteronyssinus Allergoid, Glutaraldehyde-Modified

This article discusses clinical trials investigating the use of Dermatophagoides Pteronyssinus Allergoid, Glutaraldehyde-Modified, a potential treatment for allergic rhinitis, rhinoconjunctivitis, and mild to moderate asthma caused by dust mite allergies. The trials aim to assess the efficacy and safety of this subcutaneous immunotherapy in patients sensitized to common dust mite species.

Table of Contents

What is Clustoid MM09?

Clustoid MM09 is a new medication being studied for the treatment of dust mite allergies[1]. It is a type of allergen immunotherapy, which means it’s designed to help your immune system become less sensitive to dust mites over time. The active ingredients in Clustoid MM09 are modified versions of proteins from two common species of dust mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae[1].

Medical Conditions Treated

Clustoid MM09 is being investigated to treat several allergy-related conditions[1]:

  • Allergic rhinitis: This is inflammation of the nasal passages due to allergies, often called “hay fever.” It can cause symptoms like sneezing, runny nose, and nasal congestion.
  • Allergic rhinoconjunctivitis: This condition affects both the nose and eyes, causing symptoms like those of allergic rhinitis plus itchy, watery eyes.
  • Allergic asthma: This is a type of asthma triggered by allergens like dust mites. It can cause breathing difficulties, wheezing, and coughing.

The medication is specifically targeted at people with moderate to severe symptoms that occur either intermittently (occasionally) or persistently (frequently)[1].

How Clustoid MM09 Works

Clustoid MM09 contains allergoids, which are modified versions of the allergens that cause dust mite allergies[1]. These allergoids are treated with a substance called glutaraldehyde, which changes their structure. This modification aims to make the allergens less likely to cause severe allergic reactions while still training your immune system to become less sensitive to dust mites over time.

Administration and Dosage

Clustoid MM09 is given as a subcutaneous injection, which means it’s injected just under the skin[1]. The maximum daily dose is 0.5 milliliters, and the treatment period can last up to 12 months[1]. However, the exact dosing schedule may vary depending on individual patient needs and will be determined by a healthcare professional.

Eligibility for Treatment

Not everyone with dust mite allergies may be eligible for treatment with Clustoid MM09. Some key eligibility criteria include[1]:

  • Age between 12 and 65 years
  • Confirmed diagnosis of dust mite allergy
  • Moderate to severe allergy symptoms
  • No severe or uncontrolled asthma
  • No previous severe reactions to allergy tests
  • No autoimmune diseases or immunodeficiencies

A healthcare professional will need to assess your individual situation to determine if this treatment is appropriate for you.

Potential Benefits

The ongoing clinical trial aims to evaluate several potential benefits of Clustoid MM09, including[1]:

  • Reduction in allergy symptoms
  • Decreased need for allergy medications
  • Improvement in quality of life
  • Reduction in asthma exacerbations (for those with allergic asthma)
  • Changes in immune system markers related to allergy

Safety Considerations

As with any medical treatment, there are potential risks and side effects to consider. The clinical trial is closely monitoring the safety of Clustoid MM09, including any adverse events that may occur[1]. Some people may experience reactions at the injection site or systemic reactions (affecting the whole body). It’s important to discuss potential risks with a healthcare professional.

Ongoing Clinical Trial

Clustoid MM09 is currently being studied in a Phase III clinical trial[1]. This is an advanced stage of research where the medication is being tested on a large group of people to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments. The trial is described as:

  • Prospective: It will follow participants forward in time
  • Multicenter: It’s being conducted at multiple medical centers
  • Randomized: Participants are randomly assigned to either receive Clustoid MM09 or a placebo
  • Double-blind: Neither the participants nor the researchers know who is receiving the actual medication
  • Placebo-controlled: The effects of Clustoid MM09 will be compared to those of a placebo (an inactive substance)

The results of this trial will help determine whether Clustoid MM09 is safe and effective for treating dust mite allergies[1].

Aspect Details
Study Type Phase III clinical trial
Design Prospective, multicenter, randomized, double-blind, placebo-controlled
Intervention Subcutaneous immunotherapy with Clustoid MM09 (Dermatophagoides pteronyssinus and Dermatophagoides farinae allergoids)
Target Condition Moderate to severe allergic rhinitis/rhinoconjunctivitis with or without mild to moderate controlled asthma
Age Range 12-65 years
Primary Outcome Combined symptom and medication score for rhinitis/rhinoconjunctivitis and asthma
Key Secondary Outcomes Individual symptom and medication scores, quality of life, immunological parameters, safety assessments
Treatment Duration Up to 12 months
Maximum Daily Dose 0.5 ml

FAQ

  • What is the main purpose of the clinical trial using Dermatophagoides Pteronyssinus Allergoid? The main purpose is to evaluate the clinical efficacy of subcutaneously administered polymerised allergen extracts compared to placebo in subjects with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma.
  • Who can participate in this clinical trial? Participants should be between 12 and 65 years old, have a confirmed clinical history of inhalant allergy caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae, and meet specific criteria for skin prick tests and IgE levels. They should have moderate to severe rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma.
  • How is the medication administered in this trial? The medication, called Clustoid MM09, is administered subcutaneously (under the skin) as a suspension for injection.
  • What are the main outcomes being measured in this trial? The primary outcome is the combined symptom score and medication intake for rhinitis/rhinoconjunctivitis and asthma. Secondary outcomes include individual symptom and medication scores, quality of life, immunological parameters, and safety assessments.
  • Are there any specific exclusion criteria for this trial? Yes, some exclusion criteria include: having received immunotherapy in the past 5 years, having autoimmune diseases or immunodeficiencies, severe or uncontrolled persistent asthma, pregnancy or breastfeeding, and being on β-blocker treatment, among others.

Ongoing Clinical Trials on Dermatophagoides Pteronyssinus Allergoid, Glutaraldehyde-Modified

  • 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

  • Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Lepidoglyphus destructor Immunotherapy for Allergic Rhinitis and Rhinoconjunctivitis in Patients With or Without Mild Asthma

    Not yet recruiting

    3 1
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of CLU-RX-DPT for Patients with Moderate-to-Severe House Dust Mite Allergy

    Not recruiting

    4 1
    Investigated drugs:
    Germany Spain

  • Study on the Effectiveness and Safety of Clustoid MM09 for Patients with Allergic Rhinitis or Rhinoconjunctivitis, with or without Mild to Moderate Asthma

    Not recruiting

    3 1
    Investigated drugs:
    Spain

Glossary

  • Allergoid: A modified form of an allergen that has been chemically altered to reduce its ability to cause allergic reactions while maintaining its ability to stimulate the immune system for therapeutic purposes.
  • Dermatophagoides pteronyssinus: A species of house dust mite that is a common cause of allergies in humans.
  • Rhinitis: Inflammation of the nasal passages, often causing symptoms such as sneezing, runny nose, and nasal congestion.
  • Rhinoconjunctivitis: A condition characterized by inflammation of both the nasal passages and the conjunctiva (the membrane covering the white part of the eye), typically causing symptoms in both areas.
  • Subcutaneous immunotherapy: A form of allergy treatment where small amounts of allergens are injected under the skin to help the body build tolerance to those allergens over time.
  • IgE (Immunoglobulin E): A type of antibody that plays a crucial role in allergic reactions. High levels of specific IgE indicate sensitization to particular allergens.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function used to assess the severity of asthma and other respiratory conditions.
  • ARIA classification: Allergic Rhinitis and its Impact on Asthma, a system used to classify the severity and duration of allergic rhinitis symptoms.
  • GEMA 5.0: Spanish Guidelines for Asthma Management, version 5.0, used to define and classify asthma severity and control.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-clustoid-mm09-for-patients-with-allergic-rhinitis-or-rhinoconjunctivitis-with-or-without-mild-to-moderate-asthma/