Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy

Rhinitis Clinical Trial

— MG56  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654223
• Other study ID #: MG56-SIT-012
• Secondary ID: 2014-005471-88
• Status: Completed
• Phase: Phase 2
• Start date: December 30, 2015
• Est. completion date: November 2021

Study information

• Verified date: January 2022
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Hypersensitivity
• Rhinitis
• Rhinitis, Allergic, Seasonal
• Rhinoconjunctivitis

Intervention

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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Subcutaneous placebo
Comparison between placebo and active group
• Sublingual placebo
Comparison between placebo and active group

Locations

Country	Name	City	State
Spain	Clínica Atlas	Aranjuez	Madrid
Spain	Hospital Nisa Aljarafe	Castilleja De La Cuesta	Sevilla
Spain	Hospital San Agustín	Dos Hermanas	Sevilla
Spain	CLÍNICA Dr. SUBIZA	Madrid
Spain	Clínica Ojeda	Madrid
Spain	HOSPITAL UNIVERSITARIO 12 de OCTUBRE	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Viamed Santa Angola de la Cruz	Sevilla
Spain	Hospital Universitario Infanta Elena	Valdemoro	Madrid
Spain	Clínica Alianza Médica	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration required to elicit a positive response after nasal provocation test (NPT)	Change in the threshold concentration of grass 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	Dose finding skin prick test	Comparison between the beginning and end of the trial and among active groups and placebo	4 months
Secondary	Cytokine production by T cells specific allergen	Comparison between the beginning and end of the trial and among active groups and placebo	4 months
Secondary	Immunoglobulin production by B cells specific allergen	Comparison between the beginning and end of the trial and among active groups and placebo	4 months
Secondary	Phenotypic and functional analysis of dendritic cells	Will be analyzed changes in the frequency of plasmacytoid dendritic cells, myeloid dendritic cell and Treg cells in peripheral blood, between the beginning and end of the trial and among active groups and placebo; The frequencies of peripheral blood mononuclear cells in each of the above populations is determined before and after treatment with mannosylated polymers by flow cytometry after staining with specific antibodies.	4 months
Secondary	Number of participants with treatment-related adverse events as assessed by MG56-SIT-012	Comparison between the beginning and end of the trial and among active groups and placebo	4 months