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

NCT ID: NCT02654223

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-30
• Study Completion Date: 2021-11-30

Brief Summary

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

Detailed Description

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

Conditions

Rhinitis; Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

MG56 Mannosylated 500 subcutaneous

500 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 500 subcutaneous

Intervention Type: BIOLOGICAL

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

Sublingual placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 1000 subcutaneous

1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 1000 subcutaneous

Intervention Type: BIOLOGICAL

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

Sublingual placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 3000 subcutaneous

3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 3000 subcutaneous

Intervention Type: BIOLOGICAL

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

Sublingual placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 5000 subcutaneous

5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 5000 subcutaneous

Intervention Type: BIOLOGICAL

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

Sublingual placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 500 sublingual

500 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 500 sublingual

Intervention Type: BIOLOGICAL

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

Subcutaneous placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 1000 sublingual

1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 1000 sublingual

Intervention Type: BIOLOGICAL

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

Subcutaneous placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 3000 sublingual

3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 3000 sublingual

Intervention Type: BIOLOGICAL

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

Subcutaneous placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

MG56 Mannosylated 5000 sublingual

5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.

Group Type: EXPERIMENTAL

MG56 Mannosylated 5000 sublingual

Intervention Type: BIOLOGICAL

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

Subcutaneous placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

Placebo Sublingual Placebo subcutaneous

Sublingual and subcutaneous placebo.

Group Type: PLACEBO_COMPARATOR

Subcutaneous placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

Sublingual placebo

Intervention Type: BIOLOGICAL

Comparison between placebo and active group

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Subcutaneous placebo

Comparison between placebo and active group

Intervention Type: BIOLOGICAL

Sublingual placebo

Comparison between placebo and active group

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inmunotek S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Subiza, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Subliza

Carmen Diéguez, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Pedro Ojeda, PhD; MD

Role: STUDY_DIRECTOR

Clínica Ojeda

Javier Ruiz Hornillos, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Infanta Elena

Matilde Domínguez, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro

Emilio Solano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Antonio Moreno

Role: PRINCIPAL_INVESTIGATOR

Clínica Atlas

Pedro Guardia

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Agustín Orovigt

Role: PRINCIPAL_INVESTIGATOR

Hospital Viamed Santa Ángela de la Cruz

Alberto Caso

Role: PRINCIPAL_INVESTIGATOR

Hospital San Agustín

Alicia Alonso

Role: PRINCIPAL_INVESTIGATOR

Clínica Alianza Médica

Amparo Conde

Role: PRINCIPAL_INVESTIGATOR

Hospital Nisa Sevilla Aljarafe

Locations

Clínica Atlas

Aranjuez, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario Infanta Elena

Valdemoro, 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 Ramón y Cajal

Madrid, , Spain

HOSPITAL UNIVERSITARIO 12 de OCTUBRE

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Viamed Santa Angola de la Cruz

Seville, , Spain

Clínica Alianza Médica

Valladolid, , Spain

Countries

Spain

References

Ojeda P, Barjau MC, Subiza J, Moreno A, Ojeda I, Solano E, Alonso A, Caballero R, Del Pozo S, Gomez-Perosanz M, Sanchez-Trincado JL, Benito-Villalvilla C, Angelina A, Soria I, Reche PA, Palomares O, Subiza JL, Casanovas M. Grass pollen allergoids conjugated with mannan for subcutaneous and sublingual immunotherapy: a dose-finding study. Front Immunol. 2024 Jun 26;15:1431351. doi: 10.3389/fimmu.2024.1431351. eCollection 2024.

Reference Type: DERIVED

PMID: 38989287 (View on PubMed)

Other Identifiers

2014-005471-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MG56-SIT-012

Identifier Type: -

Identifier Source: org_study_id