Status unknownNCT02661854MM09Updated Mar 11, 2020

Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy

A Phase 2 interventional study of MM09 Mannosylated 5.000 subcutaneous and MM09 Mannosylated 10.000 subcutaneous in Rhinitis and Rhinoconjunctivitis, sponsored by Inmunotek S.L.. Status unknown at 14 sites in Spain. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by Inmunotek S.L. · Phase 2, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 186
Allocation: Randomized
Ages: 12 Years to 65 Years
Sex: All

Study summary

The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy

Read the detailed description

Double blind placebo-controlled study. The subjects will receive medication during 4 months.

Conditions studied

Rhinitis
Rhinoconjunctivitis

Browse trials for

Keywords

Rhinitis / Rhinoconjunctivitis
Vaccine
Immunotherapy
Mite
Allergy

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 186 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Inmunotek S.L. is the lead sponsor of 23 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Written informed consent
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

Exclusion Criteria:

Subjects outside of the age range.
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.

Study design

Phase: Phase 2
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 186 participants (actual)

Study arms

Experimental
MM09 Mannosylated 5.000 subcutaneous
5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 5.000 subcutaneous · Biological: Sublingual placebo
Experimental
MM09 Mannosylated 10.000 subcutaneous
10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 10.000 subcutaneous · Biological: Sublingual placebo
Experimental
MM09 Mannosylated 30.000 subcutaneous
30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 30.000 subcutaneous · Biological: Sublingual placebo
Experimental
MM09 Mannosylated 50.000 subcutaneous
50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 50.000 subcutaneous · Biological: Sublingual placebo
Experimental
MM09 Mannosylated 5.000 sublingual
5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 5.000 sublingual · Biological: Subcutaneous placebo
Experimental
MM09 Mannosylated 10.000 sublingual
10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 10.000 sublingual · Biological: Subcutaneous placebo
Experimental
MM09 Mannosylated 30.000 sublingual
30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 30.000 sublingual · Biological: Subcutaneous placebo
Experimental
MM09 Mannosylated 50.000 sublingual
50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 50.000 sublingual · Biological: Subcutaneous placebo
Placebo comparator
Placebo Sublingual Placebo subcutaneous
Sublingual and subcutaneous placebo.
Biological: Subcutaneous placebo · Biological: Sublingual placebo

Interventions

BiologicalMM09 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
Also known as: Manano
BiologicalMM09 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
BiologicalMM09 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
BiologicalMM09 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
BiologicalMM09 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
BiologicalMM09 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
BiologicalMM09 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
BiologicalMM09 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
BiologicalSubcutaneous placebo
Comparison between placebo and active group
BiologicalSublingual placebo
Comparison between placebo and active group

What researchers measure

Primary outcomes

Concentration required to elicit a positive response after nasal provocation test (NPT)
Change in the threshold concentration of mite allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry. This will be compared between the beginning and end of the trial and among active groups and placebo.
Time frame: 4 months

Secondary outcomes

Dose finding skin prick test
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 4 months
Number of participants with treatment-related adverse events as assessed by MM09-SIT-013
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 4 months

Study locations

14 sites

Hospital General Universitario de Elche
Elche, Alicante 03203, Spain
Hospital Del Vinalopo
Elche, Alicante 03293, Spain
Hospital General Universitario de Elda-Virgen de La Salud
Elda, Alicante 03600, Spain
Hospital Vega Baja Orihuela
Orihuela, Alicante 03314, Spain
Hospital Universitari de Castelló
Castellón de la Plana, Castellón 12004, Spain
Hospital de La Plana
Vila-real, Castellón 12540, Spain
Hospital de Manises
Manises, Valencia 46940, Spain
Hospital Lluis Alcanyis de Xátiva
Xátiva, Valencia 46800, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Vithas Internacional Medimar
Alicante, 03016, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults
Valencia, 46026, Spain
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child
Valencia, 46026, Spain

References and documents

Publications

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. PubMed 29319882 ↗
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. PubMed 26603537 ↗
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. PubMed 27177779 ↗
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. PubMed 28778325 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02661854
Lead sponsor: Inmunotek S.L.
Responsible party: Sponsor
First posted: Jan 25, 2016
Start date: Jun 21, 2016
Primary completion: Jul 2020 (estimated)
Completion: Jul 2020 (estimated)
Last update: Mar 11, 2020

Study contacts

Mª Dolores Hernández, PhD; MD

principal investigator

Pilar Alba, PhD; MD

principal investigator

Carmen Pérez, PhD; MD

principal investigator

Javier Montoro, PhD; MD

principal investigator

Antonio de Mateo, PhD; MD

principal investigator

David El-Qutob, PhD; MD

principal investigator

Javier Fernández, PhD; MD

principal investigator

Vicente Jover, PhD; MD

principal investigator

Isabel Flores, PhD; MD

principal investigator

Mónica Antón, PhD; MD

principal investigator

Carmen Andreu, PhD; MD

principal investigator

Luis Angel Navarro, PhD; MD

principal investigator

Ángel Ferrer

principal investigator

Antonio Nieto, PhD; MD

study director

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Inmunotek S.L.

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Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy

Study summary

Conditions studied

Browse trials for

Keywords

In context

Rhinitis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria