Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy
MM09
Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against a Mixture of Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract
2 other identifiers
interventional
186
1 country
14
Brief Summary
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2016
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 25, 2016
CompletedStudy Start
First participant enrolled
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedMarch 11, 2020
March 1, 2020
4 years
January 20, 2016
March 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 months
Secondary Outcomes (2)
Dose finding skin prick test
4 months
Number of participants with treatment-related adverse events as assessed by MM09-SIT-013
4 months
Study Arms (9)
MM09 Mannosylated 5.000 subcutaneous
EXPERIMENTAL5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 10.000 subcutaneous
EXPERIMENTAL10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 30.000 subcutaneous
EXPERIMENTAL30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 50.000 subcutaneous
EXPERIMENTAL50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
MM09 Mannosylated 5.000 sublingual
EXPERIMENTAL5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 10.000 sublingual
EXPERIMENTAL10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 30.000 sublingual
EXPERIMENTAL30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
MM09 Mannosylated 50.000 sublingual
EXPERIMENTAL50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Placebo Sublingual Placebo subcutaneous
PLACEBO COMPARATORSublingual and subcutaneous placebo.
Interventions
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml 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
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml 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
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml 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
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml 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
Comparison between placebo and active group
Comparison between placebo and active group
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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 that have previously submitted a serious secondary reaction during the skin prick test
- Subjects in treatment with beta blockers.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inmunotek S.L.lead
Study Sites (14)
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
Castellon, 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
Related Publications (4)
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.
PMID: 29319882BACKGROUNDManzano 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.
PMID: 26603537BACKGROUNDSirvent 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.
PMID: 27177779BACKGROUNDSoria 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.
PMID: 28778325BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
- STUDY DIRECTOR
Antonio Nieto, PhD; MD
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2016
First Posted
January 25, 2016
Study Start
June 21, 2016
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
March 11, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share