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

Sponsor

Inmunotek S.L. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02661854

Collaborator

(none)

186

Enrollment

Locations

Arms

48.3

Anticipated Duration (Months)

13.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rhinitis Rhinoconjunctivitis	Biological: MM09 Mannosylated 5.000 subcutaneous Biological: MM09 Mannosylated 10.000 subcutaneous Biological: MM09 Mannosylated 30.000 subcutaneous Biological: MM09 Mannosylated 50.000 subcutaneous Biological: MM09 Mannosylated 5.000 sublingual Biological: MM09 Mannosylated 10.000 sublingual Biological: MM09 Mannosylated 30.000 sublingual Biological: MM09 Mannosylated 50.000 sublingual Biological: Subcutaneous placebo Biological: Sublingual placebo	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jun 21, 2016

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Concentration required to elicit a positive response after nasal provocation test (NPT) [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Universitario de Elche	Elche	Alicante	Spain	03203
2	Hospital Del Vinalopo	Elche	Alicante	Spain	03293
3	Hospital General Universitario de Elda-Virgen de La Salud	Elda	Alicante	Spain	03600
4	Hospital Vega Baja Orihuela	Orihuela	Alicante	Spain	03314
5	Hospital Universitari de Castelló	Castellón de la Plana	Castellón	Spain	12004
6	Hospital de La Plana	Vila-real	Castellón	Spain	12540
7	Hospital de Manises	Manises	Valencia	Spain	46940
8	Hospital Lluis Alcanyis de Xátiva	Xátiva	Valencia	Spain	46800
9	Hospital General Universitario de Alicante	Alicante		Spain	03010
10	Hospital Vithas Internacional Medimar	Alicante		Spain	03016
11	Hospital Arnau de Vilanova	Valencia		Spain	46015
12	Hospital Universitario Doctor Peset	Valencia		Spain	46017
13	HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults	Valencia		Spain	46026
14	HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child	Valencia		Spain	46026