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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005471-88 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG56 Mannosylated 500 subcutaneous | Experimental | 500 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
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| MG56 Mannosylated 1000 subcutaneous | Experimental | 1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
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| MG56 Mannosylated 3000 subcutaneous | Experimental | 3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
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| MG56 Mannosylated 5000 subcutaneous | Experimental | 5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
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| MG56 Mannosylated 500 sublingual | Experimental | 500 mTU/mL of sublingual immunotherapy and subcutaneous placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG56 Mannosylated 500 subcutaneous | Biological | Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose finding skin prick test | Comparison between the beginning and end of the trial and among active groups and placebo | 4 months |
| Cytokine production by T cells specific allergen | Comparison between the beginning and end of the trial and among active groups and placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Subiza, PhD; MD | Clinica Subliza | Principal Investigator |
| Carmen Diéguez, PhD; MD | Hospital Universitario 12 de Octubre | Principal Investigator |
| Pedro Ojeda, PhD; MD | Clínica Ojeda | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Atlas | Aranjuez | Madrid | 28300 | Spain | ||
| Hospital Universitario Puerta de Hierro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38989287 | Derived | 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. |
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| 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. |
|
| MG56 Mannosylated 1000 subcutaneous | Biological | 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 | Biological | 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 | Biological | 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 | Biological | 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 | Biological | 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 | Biological | 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 | 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 | Biological | Comparison between placebo and active group |
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| Sublingual placebo | Biological | Comparison between placebo and active group |
|
| 4 months |
| Immunoglobulin production by B cells specific allergen | Comparison between the beginning and end of the trial and among active groups and placebo | 4 months |
| 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 |
| 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 |
| Alberto Caso |
| Hospital San Agustín |
| Principal Investigator |
| Alicia Alonso | Clínica Alianza Médica | Principal Investigator |
| Amparo Conde | Hospital Nisa Sevilla Aljarafe | Principal Investigator |
| 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 |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007154 | Immune System Diseases |
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