E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects who are allergic to Ragweed. |
Soggetti allergici ad Ambrosia. |
|
E.1.1.1 | Medical condition in easily understood language |
Ragweed allergic subjects. |
Allergici ad 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 | 14.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021428 |
E.1.2 | Term | Immune system disorders |
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 |
Evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually vs oral-vestibular;
Assess the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually at a dose doubled 400 STU/dose vaccine compared to the commonly used marketing 200 STU/dose. |
Valutare la percentuale di cellule CD14-PDL-1-IL10+ circolanti allergene-specifiche in pazienti allergici all'ambrosia sottoposti a ciclo pre-costagionale di SLIT somministrata per via sublinguale vs orale-vestibolare;
Valutare la percentuale di cellule CD14-PDL-1-IL10+ circolanti allergene-specifiche in pazienti allergici all'ambrosia sottoposti a ciclo pre-costagionale di SLIT somministrata per via sublinguale a una dose raddoppiata 400 STU/dose rispetto al vaccino comunemente in uso in commercio 200 STU/dose. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually;
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose;
Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually;
Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose. |
Valutazione della efficacia clinica nel gruppo di pazienti trattati con vaccino sublinguale per via vestibolare rispetto a quelli trattati per via sublinguale.
Valutazione dell'efficacia clinica nel gruppo di pazienti trattati con vaccino sublinguale a dosaggio doppio rispetto a quelli con dosaggio standard.
Valutazione della sicurezza e della tollerabilità nel gruppo di pazienti trattati con vaccino sublinguale per via vestibolare rispetto a quelli trattati per via sublinguale.
Valutazione della sicurezza e della tollerabilità nel gruppo di pazienti trattati con vaccino sublinguale a dosaggio raddoppiato rispetto a quelli trattati con dosaggio standard. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults aged 18-55 years, known allergy to ragweed pollen, no immunotherapy or in progress prior to enrollement, symptoms of rhino/conjunctivitis with or without asthma. |
Adulti di età compresa tra i 18 e i 55 anni, allergia accertata all'Ambrosia, nessuna immunoterapia in corso o precedente l'arruolamento, sintomi di rino-congiuntivite con o senza asma. |
|
E.4 | Principal exclusion criteria |
Allergic to perennial allergens (moulds, mites and animal when exposed to the animal), patients with chronic diseases (infectious, autoimmune cancer, heart or kidney), pregnancy, chronic drug treatment with steroids and/or immunosuppressive drugs, oral diseases. |
Pazienti allergici ad allergeni perenni, pazienti affetti da malattie croniche, gravidanza in atto, trattamenti farmacologici cronici con steroidi o immunosoppressori, malattie del cavo orale. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The end of the study will detect a difference between groups with respect to the primary objective, the percentage of CD14-PDL-1-IL10 + outstanding of at least 25 percentile points. |
Alla fine dello studio si rileverà una differenza tra i gruppi di percentuale di cellule CD14-PDL-1-IL10+ circolanti pari almeno a 25 punti percentili. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At study termination (3 months). |
Al termine dello studio (3 mesi). |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable. |
Non applicabile. |
|
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 | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 |
altra via di somministrazione. - Stesso farmaco ad altro dosaggio |
other mode of administration. - 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |