Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy (MM09)

March 10, 2020 updated by: Inmunotek S.L.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Sublingual Placebo subcutaneous
Sublingual and subcutaneous placebo.
Biological: Sublingual placebo
Comparison between placebo and active group
Biological: Subcutaneous placebo
Comparison between placebo and active group
Experimental: MM09 Mannosylated 5.000 subcutaneous
5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: Sublingual placebo
Comparison between placebo and active group
Biological: 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
Other Names:
  • Manano
Experimental: MM09 Mannosylated 10.000 subcutaneous
10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: Sublingual placebo
Comparison between placebo and active group
Biological: 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
Experimental: MM09 Mannosylated 30.000 subcutaneous
30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: Sublingual placebo
Comparison between placebo and active group
Biological: 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
Experimental: MM09 Mannosylated 50.000 subcutaneous
50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: Sublingual placebo
Comparison between placebo and active group
Biological: 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
Experimental: MM09 Mannosylated 5.000 sublingual
5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: Subcutaneous placebo
Comparison between placebo and active group
Biological: 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
Experimental: MM09 Mannosylated 10.000 sublingual
10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: Subcutaneous placebo
Comparison between placebo and active group
Biological: 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
Experimental: MM09 Mannosylated 30.000 sublingual
30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: Subcutaneous placebo
Comparison between placebo and active group
Biological: 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
Experimental: MM09 Mannosylated 50.000 sublingual
50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: Subcutaneous placebo
Comparison between placebo and active group
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration required to elicit a positive response after nasal provocation test (NPT)
Time Frame: 4 months

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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inmunotek S.L.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2016

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM09-SIT-013
  • 2015-000820-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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