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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Castello
      • Vila-real, Castellón, Spain, 12540
        • Hospital de La Plana
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
      • Xátiva, Valencia, Spain, 46800
        • Hospital Lluis Alcanyís de Xátiva

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inmunotek S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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