E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
rhinoconjunctivitis allergic to ragweed pollen |
rinocongiuntivite allergica al polline di ambrosia |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to ragweed pollen |
Allergia al polline di ambrosia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054928 |
E.1.2 | Term | Allergy to plants |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to assess the efficacy and safety of treatment with sublingual specific immunotherapy (antiallergic vaccination) with allergoid monomeric ragweed (Ambrosia LAIS) in three different doses in patients with rhinoconjunctivitis to ragweed pollen |
valutazione dell’efficacia e della sicurezza di un trattamento di immunoterapia specifica (vaccino antiallergico)sublinguale con allergoide monomerico di ambrosia (LAIS Ambrosia) in tre diversi dosaggi in pazienti affetti da rinocongiuntivite allergica da polline di ambrosia. |
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E.2.2 | Secondary objectives of the trial |
to document the safety of treatment with LAIS Ambrosia (incidence of adverse events) |
documentare la sicurezza del trattamento con i LAIS Ambrosia compresse(incidenza di eventi avversi) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Signed Informed Consent -Male or female patients aged between 18 and 75 years with a documented history of at least two years of rhinitis and / or moderate to severe allergic rhinoconjunctivitis to ragweed pollen seasonal allergic asthma with or without controlled. -clinically relevant sensitization to ragweed pollen -Positive clinical history to ragweed pollen -Availability to attend the study visits requested by the protocol during the study participation -Negative Pregnancy Urinary test (if female in fertile age) -If woman is of fertile age, she has been using a highly efficacious method of birth control for at least one month before the study enrolment and agrees to continue the use for the entire duration of the study. -Capable to fully understand the protocol and be compliant to the instructions reported in the protocol itself. -Positive response to the TPN test. |
- Consenso informato firmato e datato. - Maschi e femmine di età fra 18 e 75 anni con una storia documentata di almeno due anni di rinite e/o rinocongiuntivite allergica moderata-grave da polline di ambrosia con o senza asma allergica stagionale controllata. - Sensibilizzazione clinicamente rilevante a polline di ambrosia. - Storia clinica positiva per polline di ambrosia. - Disponibilità a presentarsi alle visite previste dal protocollo per tutta la durata dello studio. - Test urinario di gravidanza negativo (se donne in età fertile). - Se donne in età fertile, che stiano utilizzando un metodo altamente efficace di controllo delle nascite, da almeno un mese prima dell’arruolamento e che acconsentano a continuare ad utilizzarlo per tutta la durata dello studio. - In grado di comprendere pienamente il protocollo e di aderire alle istruzioni in esso presenti. - Risposta positiva al test di provocazione nasale TPN. |
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E.4 | Principal exclusion criteria |
- Concomitant participation in other interventional clinical trials - Previous immunotherapy with ragweed allergen in the last 3 years. - Ongoing immunotherapy. - clinically relevant sensitization to other stagional aereous allergens such as Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, and/or to perennial allergens like house dust mites, cats and dogs dander. - Patients being in any relationship or dependence with the sponsor and/or investigator - Other reasons contra-indicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions) - Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection - Predominant perennial allergic rhinitis - Partly controlled or uncontrolled asthma - Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value - Galactose-intolerance or malabsorption syndrome - Active tuberculosis - Generally inflammatory as well severe acute and chronic inflammatory diseases - Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis) - Immune deficiency (for example induced by immunosuppressive drugs) - Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism - Malignancy - Alcohol abuse. |
- Partecipazione contemporanea ad altri studi clinici interventistici. - Precedente immunoterapia con allergeni di ambrosia negli ultimi 3 anni. - Immunoterapia specifica in corso. - Sensibilizzazione clinicamente rilevante ad altri allergeni aerei stagionali quali Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, e/o perenni quali cane, gatto (se in casa) o acari. - Pazienti con qualunque rapporto o dipendenza dallo sponsor e/o dallo Sperimentatore. - Altre ragioni che sconsiglino l’inclusione nello studio clinico secondo la valutazione dello Sperimentatore (ad esempio, scarsa compliance, incapacità del paziente di comprendere i documenti e le istruzioni di studio). - Gravidanza in essere o prevista, allattamento e/o mancanza di protezione contraccettiva adeguata. - Rinite allergica perenne predominante. - Asma parzialmente controllata o incontrollata. - Asma cronica o enfisema, in particolare con un FEV < 70% del valore previsto misurato tramite spirometria. - Intolleranza al lattosio o sindrome da malassorbimento. - Tubercolosi attiva. - Malattie infiammatorie generali, nonché malattie infiammatorie gravi acute e croniche. - Disordini secondari irreversibili all’organo bersaglio (enfisema, bronchiectasia). - Immunodeficienza (ad esempio indotta da farmaci immunosoppressivi). - Malattie diagnosticate da un medico ai reni, alla milza, al sistema nervoso, nonché malattie reumatiche basate su un meccanismo autoimmune. - Tumore maligno. - Abuso di alcol. - Controindicazioni per l’uso di adrenalina (ad esempio malattia coronaria sintomatica acuta o cronica, ipertensione grave, ipertiroidismo). - Trattamento in corso o pregresso con anticorpi anti-IgE. - Sinusite cronica o rinite medicamentosa. - Allergia all’Artemisia (IgE specifiche per Artemisia vulgaris >2,5 kU/L dosate con metodo enzimatico (CAP-test). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The efficacy of immunotherapy with sublingual tablets allergoid LAIS Ambrosia will be assessed through the measurement of individual variation in specific nasal provocation test (NPT) performed with Ambrosia Allerkin |
L’efficacia dell’immunoterapia sublinguale con compresse di allergoide LAIS Ambrosia verrà valutata attraverso la misura della variazione individuale al test di provocazione nasale specifico (TPN) effettuato con Ambrosia Allerkin Test |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- basal assesment before the randomization (same day of the first IMP administration) |
- Rilevazione basale prima della randomizzazione (stesso giorno dell'assunzione della prima compressa); - Rilevazione finale a fine trattamento, ovvero dopo 120 +/- 7gg |
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E.5.2 | Secondary end point(s) |
Incidence of Adverse Events |
Incidenza degli eventi avversi |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Randomizzation visit (basal, pre-treatment),V2 after 30 +/- 2 dd since V1, V3 after 90 +/- 7 dd since V1 and V4 after 120 +/- 7 dd since V1. |
Visita di randomizzazione (basale, pre-trattamento),V2 dopo 30 +/- 2gg da V1, V3 dopo 90 +/- 7gg da V1 e V4 dopo 120 +/- 7gg da V1. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 25 |