Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy
NCT ID: NCT02661854
Last Updated: 2020-03-11
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
PHASE2
186 participants
INTERVENTIONAL
2016-06-21
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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MM09 Mannosylated 5.000 subcutaneous
5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 5.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Sublingual placebo
Comparison between placebo and active group
MM09 Mannosylated 10.000 subcutaneous
10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 10.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Sublingual placebo
Comparison between placebo and active group
MM09 Mannosylated 30.000 subcutaneous
30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 30.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Sublingual placebo
Comparison between placebo and active group
MM09 Mannosylated 50.000 subcutaneous
50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 50.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Sublingual placebo
Comparison between placebo and active group
MM09 Mannosylated 5.000 sublingual
5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 5.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Subcutaneous placebo
Comparison between placebo and active group
MM09 Mannosylated 10.000 sublingual
10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 10.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Subcutaneous placebo
Comparison between placebo and active group
MM09 Mannosylated 30.000 sublingual
30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 30.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Subcutaneous placebo
Comparison between placebo and active group
MM09 Mannosylated 50.000 sublingual
50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 50.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Subcutaneous placebo
Comparison between placebo and active group
Placebo Sublingual Placebo subcutaneous
Sublingual and subcutaneous placebo.
Subcutaneous placebo
Comparison between placebo and active group
Sublingual placebo
Comparison between placebo and active group
Interventions
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MM09 Mannosylated 5.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
MM09 Mannosylated 10.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
MM09 Mannosylated 30.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
MM09 Mannosylated 50.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
MM09 Mannosylated 5.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
MM09 Mannosylated 10.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
MM09 Mannosylated 30.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
MM09 Mannosylated 50.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Subcutaneous placebo
Comparison between placebo and active group
Sublingual placebo
Comparison between placebo and active group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae allergy
* Subjects with a positive skin prick-test (wheal sixe \>6 mm diameter)
* Specific immunoglobulin E against house dust mites \>10 kU/L and whose determination does not exceed 6 months prior to the inclusion visit
* Age between 12 and 65 years
* Both genders
* Subjects capable of giving informed consent
* Subjects capable of complying with the dosing regimen
* Subjects that have not received immunotherapy in the last 5 years
* Subjects presenting sensitization to another aeroallergens, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.
Exclusion Criteria
* Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to mites and other allergens in the last 5 years.
* Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
* Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
* Subjects with persistent severe or not controlled asthma , with a forced expiratory volume (FEV) \< 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial.
* Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
* Subjects that have previously submitted a serious secondary reaction during the skin prick test
* Subjects in treatment with beta blockers.
* Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
* Subject with chronic urticaria in the last 2 years or hereditary angioedema.
* Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
* Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney diseases,...).
* Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
* Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
* Subject with known allergy to other components of the vaccine different from mites allergen extract.
* Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
* Direct investigator's relatives.
* Pregnant or women at risk of pregnancy and breastfeeding women.
12 Years
65 Years
ALL
No
Sponsors
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Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Mª Dolores Hernández, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Pilar Alba, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Carmen Pérez, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Javier Montoro, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Antonio de Mateo, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
David El-Qutob, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Javier Fernández, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Vicente Jover, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Isabel Flores, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Mónica Antón, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Carmen Andreu, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Luis Angel Navarro, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Ángel Ferrer
Role: PRINCIPAL_INVESTIGATOR
Antonio Nieto, PhD; MD
Role: STUDY_DIRECTOR
Locations
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Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Del Vinalopo
Elche, Alicante, Spain
Hospital General Universitario de Elda-Virgen de La Salud
Elda, Alicante, Spain
Hospital Vega Baja Orihuela
Orihuela, Alicante, Spain
Hospital Universitari de Castelló
Castellon, Castellón, Spain
Hospital de La Plana
Vila-real, Castellón, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital Lluis Alcanyis de Xátiva
Xátiva, Valencia, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Vithas Internacional Medimar
Alicante, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults
Valencia, , Spain
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child
Valencia, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2015-000820-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MM09-SIT-013
Identifier Type: -
Identifier Source: org_study_id
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