Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis
NCT ID: NCT05400811
Last Updated: 2022-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2022-12-31
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.
Neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
Study Groups
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Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo
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.
MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration.
Placebo sublingual
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo
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.
MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration.
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo
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.
MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration.
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Group IV: Placebo
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
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Placebo sublingual
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Interventions
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MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration.
MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration.
MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration.
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Placebo sublingual
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
60 Years
ALL
No
Sponsors
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BioClever 2005 S.L.
OTHER
NTS hub S.L
UNKNOWN
Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Ana Isabel Tabar Purroy, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital of Navarra
Locations
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Hospital Universitario de Elche
Elche, Alicante, Spain
Policlínica Nuestra Sra del Rosario
Ibiza Town, Balearic Islands, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Hospital de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Centro Médico Quiron Salud Alicante
Alicante, , Spain
Hopital Quirón Salud Málaga
Málaga, , Spain
Clinica del Dr.Pérez Estrada Cornejo
Málaga, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Clínica RUSADIR
Melilla, , Spain
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, , Spain
Hospital Univeristario y Politécnico La Fe
Valencia, , Spain
Hospital Universitario de la Plana
Vila-real, , Spain
Countries
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Central Contacts
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Facility Contacts
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Silvia Martínez Blanco, MD, PhD
Role: primary
Adriana Machinena, MD. PhD
Role: primary
Marta Viñas, MD. PhD
Role: primary
Ana Isabel Tabar Purroy, MD. PhD
Role: primary
Inmaculada Sánchez Machin, MD, PhD
Role: primary
Antonio Parra Arrondo, MD, PhD
Role: primary
Luis Moral, MD, PhD
Role: primary
Angel Ferrer, MD, PhD
Role: primary
Leticia Herrero Lifona, MD, PhD
Role: primary
Manuel Pérez Estrada Cornejo, MD. PhD
Role: primary
Carmén Rondón, MD, PhD
Role: primary
Oliver Alexis Muñoz Daga, MD, PhD
Role: primary
Francisco David El-Qutob López, MD. PhD
Role: primary
References
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Benito-Villalvilla C, Soria I, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to mannan. Allergo J Int. 2018;27(8):256-262. doi: 10.1007/s40629-018-0069-8. Epub 2018 May 18.
Sirvent S, Soria I, Cirauqui C, Cases B, Manzano AI, Diez-Rivero CM, Reche PA, Lopez-Relano J, Martinez-Naves E, Canada FJ, Jimenez-Barbero J, Subiza J, Casanovas M, Fernandez-Caldas E, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to nonoxidized mannan enhance allergen uptake and induce functional regulatory T cells through programmed death ligand 1. J Allergy Clin Immunol. 2016 Aug;138(2):558-567.e11. doi: 10.1016/j.jaci.2016.02.029. Epub 2016 Apr 13.
Manzano AI, Javier Canada F, Cases B, Sirvent S, Soria I, Palomares O, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Subiza JL. Structural studies of novel glycoconjugates from polymerized allergens (allergoids) and mannans as allergy vaccines. Glycoconj J. 2016 Feb;33(1):93-101. doi: 10.1007/s10719-015-9640-4. Epub 2015 Nov 25.
Soria I, Lopez-Relano J, Vinuela M, Tudela JI, Angelina A, Benito-Villalvilla C, Diez-Rivero CM, Cases B, Manzano AI, Fernandez-Caldas E, Casanovas M, Palomares O, Subiza JL. Oral myeloid cells uptake allergoids coupled to mannan driving Th1/Treg responses upon sublingual delivery in mice. Allergy. 2018 Apr;73(4):875-884. doi: 10.1111/all.13396. Epub 2018 Jan 31.
Soria I, Alvarez J, Manzano AI, Lopez-Relano J, Cases B, Mas-Fontao A, Canada FJ, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Palomares O, Vinals-Florez LM, Subiza JL. Mite allergoids coupled to nonoxidized mannan from Saccharomyces cerevisae efficiently target canine dendritic cells for novel allergy immunotherapy in veterinary medicine. Vet Immunol Immunopathol. 2017 Aug;190:65-72. doi: 10.1016/j.vetimm.2017.07.004. Epub 2017 Jul 23.
Gonzalez JL, Zalve V, Fernandez-Caldas E, Cases B, Subiza JL, Casanovas M. A pilot study of immunotherapy in dogs with atopic dermatitis using a mannan-Dermatophagoides farinae allergoid targeting dendritic cells. Vet Dermatol. 2018 Oct;29(5):449-e152. doi: 10.1111/vde.12679.
Other Identifiers
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MM09-SIT-040
Identifier Type: -
Identifier Source: org_study_id
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