Etiological treatment of mild to moderate controlled intermittent or persistent allergic asthma and intermittent or persistent allergic rhinitis / rhinoconjunctivitis MedDRA version: 20.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870 MedDRA version: 21.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rh
Conditions
Interventions
Product Name: MM09 allergoid-mannan conjugates SC (3.000)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: MM09 allergoid-mannan conjugates
Other descriptive
Sponsors
Inmunotek, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ß-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to evaluate the clinical efficacy of allergoid-mannan conjugates administered subcutaneously and sublingually, comparing with placebo in subjects with intermittent or persistent (mild-moderate) controlled asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, by means of the combined score of symptoms and medication consumption related to the study pathologies for each trial subject;Secondary Objective: To assess the safety & indirect efficacy of allergoid-mannan conjugates administered subcutaneously and sublingually, by comparisons between active groups & placebo, on the secondary variables: -Free-Symptom & Free-medication days for asthma&rhinitis/Rhinoconjunctivitis -Lung function:FEV1&PEF test -Time to first asthma exacerbation; number, length & severity -Time to appearance of clinical benefit -Immunological parameters: total IgE, specific IgE&IgG4, specific IgE/total IgE index & anti-Saccharomyces cerevisiae (ASCA) IgA&IgG - Asthma Quality of Life Questionnaire (AQLQ) - Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Asthma Control Questionnaire (ACQ) -Visual Analogue Scale -Consumption of health resources -Adverse event global rate, severity & relation to the IMP per administration & participant -Evaluation of reactions at the site of administration, systemic reactions & of any medications administered for the treatment of AA;Primary end point(s): Combined score of symptoms and medication consumption throughout the trial, for both asthma and rhinitis/rhinoconjunctivitis.;Timepoint(s) of evaluation of this end point: Beginning and end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A quantitative comparison will be made both at the beginning and at the end of the trial for each subject and between the different groups of active treatment and placebo. The following parameters will be analyzed: - Symptom score and asthma medication intake. - Symptom score and rhinitis medication consumption. - In asthma: Free-Symptom days and Free-Medication days - In rhinitis/Rhinoconjunctivitis: Free-Symptom days and Free-medication days - Lung function:FEV1 & PEF test - Time to first asthma exacerbation; number, length & severity -Time to appearance of clinical benefit - Immunological parameters: 1. Total IgE 2. Specific IgE & IgG4 3. Specific IgE / total IgE index 4. Anti-Saccharomyces cerevisiae (ASCA) IgA&IgG - Asthma Quality of Life Questionnaire (AQLQ) - Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Asthma Control Questionnaire (ACQ) - Visual Analogue Scale (VAS) - Consumption of health resources - Security parameters: 1. Adverse event global rate, severity & relation to the IMP per administration & participant 2. Evaluation of reactions at the site of administration, systemic reactions & of any medications administered for the treatment of AA;Timepoint(s) of evaluation of this end point: Beginning and end of the trial | — |
Countries
Spain
Contacts
Public ContactMedical Department
Inmunotek, S.L.
Outcome results
None listed