Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites (MM09-SIT-023)

Inmunotek

Status and phase: Enrolling; Phase 3

Conditions: Rhinoconjunctivitis; Asthma, Allergic; Rhinitis, Allergic

Treatments: Biological: 10,000 MM09; Biological: 30,000 MM09; Biological: Placebo subcutaneous

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04435990

2018-004262-34 (EudraCT Number)

MM09-SIT-023

Details and patient eligibility

About

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Full description

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Enrollment: 150 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent.

• Age between 12 and 65, both genders.

• Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.

• Subjects with a positive skin prick-test wheal size >5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.

• Specific immunoglobulin E against house dust mites >3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources

• Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:

  • Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.
  • Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
  • Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.

• Subjects with negative skin test for fungi

• Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.

• Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.

• Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.

• Subjects capable of complying with the dosing regimen.

• Subjects who own an smartphone for symptom registration and medication

Exclusion criteria

• Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
• Subjects in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
• Subjects with persistent severe or uncontrolled asthma, with an FEV1<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.
• Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
• Subjects under treatment with β-blockers.
• Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
• Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
• Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy).
• Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
• Subject whose condition prevents him/her from offering cooperation and/or who has serious mental illness.
• Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.
• Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
• Direct investigator's relatives.
• Pregnant women or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Experimental:10,000 MM09

Experimental group

Description:

10,000 TU/mL of subcutaneous immunotherapy

Treatment:

Biological: 10,000 MM09

Experimental: 30,000 MM09

Experimental group

Description:

30,000 TU/mL of subcutaneous immunotherapy

Treatment:

Biological: 30,000 MM09

Placebo subcutaneous

Placebo Comparator group

Description:

The same solution and presentation as the active treatment, but without any active ingredients.

Treatment:

Biological: Placebo subcutaneous