Study on the Effectiveness and Safety of Sublingual MM09 for Patients Aged 12-65 with Allergies to House Dust Mites and Rhinitis/Rhinoconjunctivitis with or without Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people who are allergic to house dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. These allergies can cause symptoms like sneezing, runny nose, and itchy eyes, which are known as rhinitis or rhinoconjunctivitis. Some people with these allergies may also have mild to moderate asthma, which can cause breathing difficulties. The treatment being tested is called Sublingual MM09, which is a spray used under the tongue. It contains extracts from the house dust mites and is designed to help the body become less sensitive to these allergens over time.

The purpose of the study is to evaluate how effective and safe the Sublingual MM09 treatment is compared to a placebo, which looks like the treatment but does not contain the active ingredients. Participants in the study will use the spray daily for 12 months. The study will monitor how well the treatment works in reducing allergy symptoms and the need for other allergy medications. Participants will be asked to keep a diary of their symptoms and any medications they take during the study.

This trial is designed to be a double-blind study, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will include people aged 12 to 65 who have been diagnosed with moderate to severe rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, due to house dust mite allergies. The goal is to see if the Sublingual MM09 can help improve their quality of life by reducing allergy symptoms and the need for other treatments.

1 joining the study

Upon joining the study, participants are required to have signed and dated the informed consent form. This confirms understanding and agreement to participate in the trial.

Participants must meet specific criteria, such as being between 12 and 65 years old, having a confirmed allergy to house mites, and not being sensitized to certain other allergens.

2 baseline evaluation period

During this period, participants record symptoms and medication use for at least 10 days. This helps establish a baseline for moderate-to-severe allergic rhinitis or rhinoconjunctivitis.

Participants must own a smartphone to register symptoms and medication consumption.

3 treatment administration

Participants receive either the active treatment, Sublingual MM09, or a placebo. The active treatment contains extracts of house mites, Dermatophagoides pteronyssinus and Dermatophagoides farinae.

The treatment is administered as a sublingual spray solution, with a dosage of 30,000 TU/mL, for a duration of 12 months.

4 main evaluation period

The main evaluation period occurs during the last 4 weeks of treatment. Participants continue to record daily symptoms and medication use in their diary.

The primary focus is on the mean of the daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS).

5 secondary assessments

Secondary assessments include various symptom and medication scores related to rhinitis, rhinoconjunctivitis, and asthma.

Additional evaluations involve immunological parameters in blood samples, quality of life questionnaires, and health status perception through a visual analogue scale.

6 safety monitoring

Throughout the trial, safety parameters are monitored, including the rate and severity of adverse events per administration and per participant.

Reactions at the site of administration and systemic reactions are evaluated, along with any medication administered for the treatment of adverse events.

Who Can Join the Study?

Participants must have signed and dated the Informed Consent Form, which is a document that explains the study and confirms their willingness to participate.
Participants should not be allergic to moulds, cockroach, Blomia tropicalis, or other local mites. This is checked by a skin test or a blood test showing IgE levels less than 0.7 kU/L.
Participants must have a score of 3 or more out of 6 on a symptom scale for at least 10 days during the initial evaluation period, indicating moderate-to-severe allergic rhinitis or rhinoconjunctivitis. Rhinitis is a stuffy or runny nose, and rhinoconjunctivitis includes itchy or watery eyes.
Participants need to have specific IgE levels of 3.5 kU/L or higher against certain dust mites, Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. IgE is a type of antibody that shows allergic reactions.
Participants must be between 12 and 65 years old at the time they sign the consent form.
Participants should have a confirmed history of inhalation allergy with moderate-to-severe rhinitis or rhinoconjunctivitis for at least one year, with or without mild-to-moderate controlled asthma, caused by the specified dust mites.
Participants must have a positive skin test with a wheal (a raised, red, itchy area) of 5 mm or larger to a standardized allergen extract of the specified dust mites.
Women of childbearing age must have a negative urine pregnancy test before joining the study. Childbearing age is the time from the first menstrual period until menopause, which is when periods stop for 12 months without another medical reason.
Women of childbearing age must agree to use a reliable method of birth control during the study.
Participants must be able to follow the study’s dosage schedule.
Participants need to have a smartphone to record their symptoms and medication use.
Participants should not be allergic to any other significant allergens, or if they are, they must meet specific conditions. For example, if allergic to animal dander, they should have only occasional exposure and symptoms. If allergic to local pollen, they should be included in the study outside of the pollen season.

Who Cannot Join the Study?

Patients who have a severe form of asthma that is not well controlled cannot participate. Asthma is a condition where the airways in the lungs become narrow, making it hard to breathe.
Individuals with any other serious health conditions that could interfere with the study results are not eligible.
Pregnant or breastfeeding women are excluded from the study.
Patients who are currently participating in another clinical trial are not allowed to join this study.
Anyone with a known allergy to the study medication or its ingredients cannot take part.
Individuals who have had a severe allergic reaction in the past, known as anaphylaxis, are not eligible. Anaphylaxis is a serious and rapid allergic reaction that can be life-threatening.
Patients who have received certain types of allergy treatments recently may not be eligible.
Anyone with a history of drug or alcohol abuse may be excluded from the study.
Individuals who are unable to comply with the study procedures or follow the instructions given by the study team are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Recruiting	01.08.2024
Spain	Recruiting	01.08.2024

Trial locations

Investigated drugs:

MM09 is a sublingual immunotherapy treatment being tested for its effectiveness in patients with rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. This therapy is specifically designed for individuals who are allergic to dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. The treatment involves placing the medication under the tongue, allowing it to be absorbed directly into the bloodstream. The goal of this therapy is to reduce allergy symptoms by gradually increasing the body’s tolerance to the allergens.

Rhinitis – Rhinitis is a condition characterized by inflammation of the nasal mucous membranes, leading to symptoms such as a runny nose, sneezing, and nasal congestion. It can be caused by allergies, infections, or other factors. Allergic rhinitis is triggered by allergens like pollen, dust mites, or pet dander. The condition can be intermittent or persistent, with symptoms varying in severity. Over time, chronic rhinitis may lead to complications such as sinusitis or ear infections. Management often involves avoiding triggers and using medications to relieve symptoms.

Rhinoconjunctivitis – Rhinoconjunctivitis involves inflammation of both the nasal passages and the conjunctiva of the eyes, often due to allergies. Symptoms include a runny or stuffy nose, sneezing, itchy and watery eyes, and sometimes a sore throat. It is commonly triggered by allergens such as pollen, dust mites, or pet dander. The condition can be seasonal or perennial, depending on the allergens involved. Persistent symptoms can affect daily activities and quality of life. Avoiding allergens and using medications can help manage the symptoms.

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty breathing. Symptoms include wheezing, coughing, shortness of breath, and chest tightness, which can vary in intensity. Asthma can be triggered by allergens, respiratory infections, exercise, or environmental factors. It is often classified as intermittent or persistent, with varying degrees of control. Over time, unmanaged asthma can lead to more frequent and severe episodes. Identifying triggers and using medications can help control symptoms and prevent exacerbations.

Trial ID:

2023-505918-14-00

Protocol code:

MM09-SLG-058

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Sublingual MM09 for Patients Aged 12-65 with Allergies to House Dust Mites and Rhinitis/Rhinoconjunctivitis with or without Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?