Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis

Inmunotek

Status and phase: Not yet enrolling; Phase 3

Conditions: Perennial Allergic Rhinitis; House Dust Mite Allergy; Allergic Asthma; Allergic Rhinoconjunctivitis

Treatments: Biological: MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL); Biological: MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL); Biological: Placebo sublingual; Biological: MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL); Biological: Placebo subcutaneous

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05400811

MM09-SIT-040

Details and patient eligibility

About

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Full description

Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

The primary efficacy endpoint will be the symptom score and medication consumption required for the control of asthma and rhinitis/rhinoconjunctivitis symptoms.

The study design consists of 3 active treatment groups and one placebo group. The trial population will include 400 subjects between the age of 12 and 60 years that will receive the treatment during 12 months.

Enrollment: 400 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed and dated Informed Consent Form (ICF).
2. Female or male aged 12 to 60 years, both included.
3. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
4. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
5. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
6. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
7. Women of childbearing age must commit to using an adequate contraception method.
8. Capable of complying with dosage regimen.
9. Owning a smartphone to register symptoms and medication consumption.
10. A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance.

Exclusion criteria

1. Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
2. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
3. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
4. Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
5. Intake of β-blockers.
6. Use of immunosuppressive or biological drug.
7. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
8. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
9. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
10. Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
11. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
12. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
13. Known allergy to any of the ingredients of the study medication except for mites.
14. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
15. Breast-feeding or pregnant women.
16. Being immediate family of the investigator.
17. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
18. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

400 participants in 4 patient groups, including a placebo group

Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo

Experimental group

Description:

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3,000 UTm/mL subcutaneous immunotherapy + sublingual placebo. Subcutaneous active treatment will be administered once a month for 12 months. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months.

Treatment:

Biological: Placebo sublingual

Biological: MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)

Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo

Experimental group

Description:

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 3.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months.

Treatment:

Biological: MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)

Biological: Placebo subcutaneous

Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo

Experimental group

Description:

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 9.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months.

Treatment:

Biological: MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)

Biological: Placebo subcutaneous

Group IV: Placebo

Placebo Comparator group

Description:

Mixture of sublingual placebo + subcutaneous placebo. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months

Treatment:

Biological: Placebo sublingual

Biological: Placebo subcutaneous