Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
MG56
Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
2 other identifiers
interventional
180
1 country
12
Brief Summary
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2015
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2015
CompletedStudy Start
First participant enrolled
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJanuary 27, 2022
January 1, 2022
5.8 years
December 22, 2015
January 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Dose finding skin prick test
4 months
Cytokine production by T cells specific allergen
4 months
Immunoglobulin production by B cells specific allergen
4 months
Phenotypic and functional analysis of dendritic cells
4 months
Number of participants with treatment-related adverse events as assessed by MG56-SIT-012
4 months
Study Arms (9)
MG56 Mannosylated 500 subcutaneous
EXPERIMENTAL500 mTU/mL of subcutaneous immunotherapy and sublingual placebo.
MG56 Mannosylated 1000 subcutaneous
EXPERIMENTAL1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.
MG56 Mannosylated 3000 subcutaneous
EXPERIMENTAL3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.
MG56 Mannosylated 5000 subcutaneous
EXPERIMENTAL5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo.
MG56 Mannosylated 500 sublingual
EXPERIMENTAL500 mTU/mL of sublingual immunotherapy and subcutaneous placebo.
MG56 Mannosylated 1000 sublingual
EXPERIMENTAL1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.
MG56 Mannosylated 3000 sublingual
EXPERIMENTAL3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.
MG56 Mannosylated 5000 sublingual
EXPERIMENTAL5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo.
Placebo Sublingual Placebo subcutaneous
PLACEBO COMPARATORSublingual and subcutaneous placebo.
Interventions
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Comparison between placebo and active group
Comparison between placebo and active group
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 that have previously submitted a serious secondary reaction during the skin prick test
- Subjects in treatment with beta blockers.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inmunotek S.L.lead
Study Sites (12)
Clínica Atlas
Aranjuez, Madrid, 28300, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28342, Spain
Hospital Nisa Aljarafe
Castilleja de la Cuesta, Sevilla, 41950, Spain
Hospital San Agustín
Dos Hermanas, Sevilla, 41703, Spain
CLÍNICA Dr. SUBIZA
Madrid, 28006, Spain
Clínica Ojeda
Madrid, 28006, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
HOSPITAL UNIVERSITARIO 12 de OCTUBRE
Madrid, 28041, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Viamed Santa Angola de la Cruz
Seville, 41013, Spain
Clínica Alianza Médica
Valladolid, 47001, Spain
Related Publications (1)
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.
PMID: 38989287DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Subiza, PhD; MD
Clinica Subliza
- PRINCIPAL INVESTIGATOR
Carmen Diéguez, PhD; MD
Hospital Universitario 12 de Octubre
- STUDY DIRECTOR
Pedro Ojeda, PhD; MD
Clínica Ojeda
- PRINCIPAL INVESTIGATOR
Javier Ruiz Hornillos, PhD; MD
Hospital Universitario Infanta Elena
- PRINCIPAL INVESTIGATOR
Matilde Domínguez, PhD; MD
Hospital Universitario Puerta de Hierro
- PRINCIPAL INVESTIGATOR
Emilio Solano, MD
Hospital Universitario Ramón y Cajal
- PRINCIPAL INVESTIGATOR
Antonio Moreno
Clínica Atlas
- PRINCIPAL INVESTIGATOR
Pedro Guardia
Hospital Universitario Virgen Macarena
- PRINCIPAL INVESTIGATOR
Agustín Orovigt
Hospital Viamed Santa Ángela de la Cruz
- PRINCIPAL INVESTIGATOR
Alberto Caso
Hospital San Agustín
- PRINCIPAL INVESTIGATOR
Alicia Alonso
Clínica Alianza Médica
- PRINCIPAL INVESTIGATOR
Amparo Conde
Hospital Nisa Sevilla Aljarafe
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
January 13, 2016
Study Start
December 30, 2015
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
January 27, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share