Title

Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    mg56 ...
  • Study Participants

    180
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
Study Started
Dec 30
2015
Primary Completion
Nov 30
2021
Study Completion
Nov 30
2021
Last Update
Jan 27
2022

Biological MG56 Mannosylated 500 subcutaneous

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological MG56 Mannosylated 1000 subcutaneous

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological MG56 Mannosylated 3000 subcutaneous

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological MG56 Mannosylated 5000 subcutaneous

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological MG56 Mannosylated 500 sublingual

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual

Biological MG56 Mannosylated 1000 sublingual

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual

Biological MG56 Mannosylated 3000 sublingual

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual

Biological MG56 Mannosylated 5000 sublingual

Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual

Biological Subcutaneous placebo

Comparison between placebo and active group

Biological Sublingual placebo

Comparison between placebo and active group

MG56 Mannosylated 500 subcutaneous Experimental

500 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

MG56 Mannosylated 1000 subcutaneous Experimental

1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

MG56 Mannosylated 3000 subcutaneous Experimental

3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

MG56 Mannosylated 5000 subcutaneous Experimental

5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

MG56 Mannosylated 500 sublingual Experimental

500 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

MG56 Mannosylated 1000 sublingual Experimental

1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

MG56 Mannosylated 3000 sublingual Experimental

3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

MG56 Mannosylated 5000 sublingual Experimental

5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

Placebo Sublingual Placebo subcutaneous Placebo Comparator

Sublingual and subcutaneous placebo.

Criteria

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 grass pollen allergy
Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) Specific immunoglobulin E (IgE, CAP >3) to grass pollen
Age between 14 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 and or mites, cats or dogs, 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 grass pollen 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 pollen of grasses.
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.
No Results Posted