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    Summary
    EudraCT Number:2015-002105-11
    Sponsor's Protocol Code Number:BTT-gpASIT009
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002105-11
    A.3Full title of the trial
    A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis.
    Studio internazionale multicentrico, randomizzato in doppio cieco, controllato verso placebo, finalizzato alla dimostrazione dell'efficacia clinica e della sicurezza di un'immunoterapia sottocutanea con gpASIT+™ in pazienti con rinocongiuntivite indotta da allergia al polline di graminacee.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study where patients will receive either a new medication (grass pollen -ASIT+TM of gpASIT+TM) either placebo (an inert substance) to treat patients with grass pollen-induced allergic rhinoconjunctivitis. Both products will administered in a subcutaneous way.
    Uno studio clinico in cui i pazienti riceverà o un nuovo farmaco (polline di graminacee-ASIT+ di gpASIT+) o placebo (sostanza inerte) per il trattamento di pazienti con rinocongiuntivite indotta da allergia al polline di graminacee. Entrambi i prodotti saranno somministrati in maniera sottocutanea.
    A.3.2Name or abbreviated title of the trial where available
    BTT-gpASIT009_Phase III
    BTT-gpASIT009_Fase III
    A.4.1Sponsor's protocol code numberBTT-gpASIT009
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIOTECH TOOLS SA
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBioTech Tools S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioTech Tools S.A.
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressAv. Ariane 5
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322 264 03 95
    B.5.5Fax number+322 264 03 99
    B.5.6E-mailsabine.pirotton@biotech.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namegpASIT+TM
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgpASIT+TM
    D.3.9.2Current sponsor codegpASIT+TM
    D.3.9.3Other descriptive namePollen peptides
    D.3.9.4EV Substance CodeSUB168148
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of seasonal grass pollen rhinoconjunctivitis
    Trattamento della rinocongiuntivite stagionale indotta da allergia al polline di graminacee.
    E.1.1.1Medical condition in easily understood language
    Treatment of hay fever
    Trattamento della febbre da fieno
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10019170
    E.1.2Term Hay fever
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this clinical trial is to demonstrate the clinical efficacy of gpASIT+TM during the peak of the grass pollen season following subcutaneous administration to patients suffering from hay fever.
    Il obiettivo primario del presente studio clinico è quello di dimostrare l’efficacia clinica di gpASIT+TM durante il picco della stagione pollinica delle graminacee, in seguito a somministrazione sottocutanea in pazienti affetti da rinite allergica.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To assess individual symptom and medication scores over the peak and entire pollen season after treatment with gpASIT+TM compared to placebo,
    - To assess changes in allergic reactivity to Conjunctival Provocation Test (CPT) after treatment with gpASIT+TM compared to placebo,
    - To assess the Quality-of-Life of patients and health economic aspects after treatment with gpASIT+TM compared to placebo,
    - To assess the safety and clinical tolerability of gpASIT+TM treatment.
    Gli obiettivi secondari sono:
    - Valutare i punteggi individuali dei sintomi e del trattamento nel periodo di picco e durante l’intera stagione pollinica dopo il trattamento con gpASIT+TM rispetto al placebo;
    - Valutare i cambiamenti nella reattività allergica al test di provocazione congiuntivale (CPT) dopo il trattamento con gpASIT+TM rispetto al placebo;
    - Valutare la Qualità della vita dei pazienti e gli aspetti farmacoeconomici dopo il trattamento con gpASIT+TM rispetto al placebo;
    - Valutare la sicurezza e la tollerabilità clinica di gpASIT+TM dopo il trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed and dated Informed Consent Form by a legally competent patient
    - Female or male patients aged 18–64 years
    - The patients are in good physical and mental health according to his/her medical history and vital signs
    - For Females: non-pregnant, non-lactating females with adequate contraception or females unable to bear children (i.e. tubul ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
    - Allergy diagnosis:
    o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
    o A positive skin prick test (SPT - wheal diameter = 3 mm) to grass pollen mixture, histamine wheal = 3 mm, NaCl control reaction < 2 mm
    o Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L.
    o Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens
    - Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
    - For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)
    - For patients with co-sensitisation to birch and parietaria pollen allergens, all of the following criteria must be fulfilled:
    o The result of the SPT to birch and parietaria pollen has to be less than the result to grass pollen
    o The specific-IgE level to birch and parietaria pollen allergens has to be less than the specific-IgE level to grass (the CAP RAST class for birch and parietaria has to be at least 1 CAP RAST class less than the CAP RAST class for grass)
    I pazienti devono soddisfare i seguenti criteri di inclusione per poter partecipare allo studio:
    - Modulo di consenso informato firmato e datato da un paziente nel pieno delle proprie facoltà dal punto di vista giuridico
    - Pazienti di sesso maschile o femminile di età compresa tra 18 e 64 anni
    - Pazienti in buona salute fisica e mentale in base alla loro anamnesi e ai loro parametri vitali
    - Per le donne: non devono essere in stato di gravidanza, non devono allattare al seno e devono utilizzare un metodo contraccettivo adeguato, oppure non devono essere fisicamente in grado di iniziare una gravidanza (ad es. legatura delle tube, isterectomia o post-menopausa [definita come un minimo di un anno dall’ultimo periodo mestruale])
    - Diagnosi di allergia:
    o Una storia clinica di rinocongiuntivite stagionale allergica (SARC) da moderata a grave per la stagione pollinica delle graminacee, che sia durata per almeno le due precedenti stagioni (definizione della gravità dell’allergia secondo i criteri ARIA (Bousquet et al 2001))
    o Un prick test cutaneo positivo (SPT - diametro della reazione = 3 mm) a una miscela di pollini di graminacee, reazione all’istamina = 3 mm, reazione al controllo NaCl < 2 mm
    o IgE specifiche contro il polline delle graminacee (con allergeni ricombinanti - g213) > 0,7 kU/l.
    o Risposta positiva al CPT con almeno 10.000 SQ-E/ml di allergeni di graminacee
    - Pazienti trattati con medicinali antiallergici per almeno 2 stagioni polliniche delle graminacee prima del reclutamento
    - Per i pazienti asmatici: diagnosi confermata di asma controllata secondo le linee guida GINA (Global Initiative for Asthma) (fasi 1-3, GINA 2014)
    - Per i pazienti con sensibilizzazione concomitante agli allergeni dei pollini di betulla e parietaria, devono essere rispettati tutti i seguenti criteri:
    o Il risultato del SPT al polline di betulla e parietaria deve essere inferiore al risultato per il polline delle graminacee
    o Il livello di IgE specifiche per gli allergeni dei pollini di betulla e parietaria deve essere inferiore al livello di IgE specifiche per le graminacee (la classe CAP RAST per la betulla e la parietaria deve essere di almeno 1 classe CAP RAST inferiore rispetto alla classe CAP RAST per le graminacee)
    E.4Principal exclusion criteria
    - Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
    - Previous immunotherapy with grass allergens within the last 5 years
    - Ongoing immunotherapy with grass allergens or any other allergens
    - Patients being in any relationship or dependence with the Sponsor, CRO and/or Investigator
    - Inability to understand instructions/study documents
    - Patients with a history of anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
    - Patients with a history of hypersensitivity to the excipients of the investigational product (gpASIT+TM or placebo)
    - Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014).
    - Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
    - Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
    - Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
    - Patients with a history of significant renal disease or chronic hepatic disease
    - Patients with malignant disease
    - Patients with a known severe autoimmune disease
    - Patients with any chronic disease which may impair the patient’s ability to participate in the trial (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.)
    - Patients requiring beta-blockers/acetylcholinesterase inhibitors medication
    - Patients requiring antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
    - Patients requiring anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
    - Patients with any contraindication for the use of adrenaline
    - Patients with a known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
    - Patients who are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
    - Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
    - Consumption of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in Chapter VIII.6 of the protocol
    - Patients with laboratory values greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit *
    - Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol

    *Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit will require a retest and only if normalising, the patient will be eligible.
    - Partecipazione simultanea a un altro studio clinico o precedente partecipazione a un altro studio clinico entro 30 giorni prima dell’inclusione
    - Precedente immunoterapia con allergeni di pollini delle graminacee negli ultimi 5 anni
    - Immunoterapia in corso con allergeni di pollini delle graminacee o qualsiasi altro allergene
    - Pazienti che intrattengono qualsiasi tipo di rapporto o dipendenza con lo Sponsor, la CRO e/o lo sperimentatore
    - Incapacità di comprendere le istruzioni/i documenti dello studio
    - Pazienti con una storia clinica di anafilassi, causata da alimenti (ad es. arachidi, animali marini), veleno di imenotteri (ad es. puntura di ape o vespa) o medicinali (ad es. penicillina)
    - Pazienti con una storia di ipersensibilità agli eccipienti del medicinale sperimentale (gpASIT+TM o placebo)
    - Pazienti con asma non controllata o parzialmente controllata secondo le linee guida GINA (GINA 2014).
    - Pazienti con asma cronica o enfisema, in particolare con un volume espiratorio forzato in 1 secondo (FEV1) < 80% del valore previsto (ECSC) o con un picco di flusso espiratorio (PEF) < 70% del valore individuale ottimale
    - Pazienti sintomatici agli allergeni inalati circolanti durante la stagione pollinica delle graminacee (specifica per ogni paese: ad es. betulla, nocciolo, artemisia, ambrosia, olivo, Alternaria alternata)
    - Pazienti sintomatici ad allergeni perenni inalati (acari della polvere della casa, cane, gatto) ai quali i pazienti sono regolarmente esposti
    - Pazienti con significativa nefropatia o epatopatia cronica nell’anamnesi
    - Pazienti con patologia maligna
    - Pazienti con nota patologia autoimmune grave
    - Pazienti con qualsiasi malattia cronica che possa compromettere la capacità del paziente di prendere parte allo studio (ad es. insufficienza cardiaca congestizia, ulcera gastrica attiva, malattia infiammatoria intestinale, diabete mellito non controllato, ecc.)
    - Pazienti che necessitano di trattamenti a base di beta-bloccanti/inibitori dell’acetilcolinesterasi
    - Pazienti che necessitano di medicinali antidepressivi con potenti proprietà antistaminiche, ad es. antidepressivi triciclici (ad es. doxepina, amitriptilina, desipramina, imipramina, ecc.)
    - Pazienti che necessitano di anticorpi anti-IgE, stabilizzatori dei mastociti o antileucotrienici
    - Pazienti con qualsiasi controindicazione all’uso dell’adrenalina
    - Pazienti con una nota sierologia positiva per il virus dell’immunodeficienza umana 1/2, virus dell’epatite B o virus dell’epatite C
    - I pazienti immunocompromessi a seguito di trattamento farmacologico o di patologia sono stati trattati con un vaccino, corticosteroidi o immunosoppressori 1 mese prima dell'ammissione alla sperimentazione
    - Donne incinte, che allattano al seno, potenzialmente fertili e non protette dalla gravidanza con un metodo sufficientemente affidabile
    - Consumo di farmaci corticosteroidi (orali, topici o nasali) o antistaminici nel periodo antecedente allo studio (visita di screening), come definito nel Capitolo VIII.6 del protocollo
    - Pazienti che alla visita di screening presentano valori di laboratorio superiori al grado 2 secondo le linee guida della FDA per l’industria relative agli studi con vaccini preventivi (FDA 2007) *
    - Pazienti non affidabili, inclusi pazienti non aderenti, pazienti con noto alcolismo o abuso di sostanze o con una storia di grave disturbo psichiatrico, oltre ai pazienti che non forniscono il consenso informato o che non accettano di rispettare i requisiti del protocollo.

    *I pazienti che alla visita di screening presentano valori di laboratorio superiori al grado 1 secondo le linee guida della FDA per l’industria relative agli studi con vaccini preventivi (FDA 2007) dovranno essere sottoposti a nuove analisi; solo se i loro valori saranno in via di normalizzazione saranno considerati eleggibili.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the reduction - in the treated group compared to the placebo group - of the Combined Symptom and Medication Score (CSMS) taking into account the daily Rhinoconjunctivitis Total Symptom Score (RTSS) and the daily Rescue Medication Score (RMS) over the peak of grass pollen season subsequent to treatment.
    L’endpoint primario sarà la riduzione - nel gruppo sperimentale rispetto al gruppo trattato con placebo - del punteggio combinato sintomi-farmaci (CSMS), prendendo in considerazione il punteggio giornaliero totale dei sintomi della rinocongiuntivite (RTSS) e il punteggio giornaliero del farmaco di soccorso (RMS) durante il picco della stagione pollinica successiva al trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Reduction of the Combined Symptom and Medication Score (CSMS) during the peak of the grass pollen season.
    Riduzione del punteggio combinato sintomi-farmaci (CSMS) durante il picco della stagione pollinica.
    E.5.2Secondary end point(s)
    Combined Symptom and Medication Score (CSMS) over the entire grass pollen season; Rhinoconjunctivitis Total Symptom Score (RTSS) over the peak period and the pollen season; Rescue Medication Score (RMS) over the peak period and the pollen season; Symptom sub-scores (Eyes, Nose) over the peak period and the pollen season; Well days over the peak period and the pollen season; In asthmatic patients: lung symptoms over the peak period and the pollen season; In asthmatic patients: Total Symptom Score (TSS; the sum of the nose, eye and lung scores) over the peak period and the pollen season; In asthmatic patients: Use of rescue medication to relief asthma symptoms over the peak period and the pollen season; Conjunctival Provocation Test (CPT) outcomes
    ; Quality-of-Life Questionnaires:
    - Standardised Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ(S)) and Nocturnal Rhinoconjunctivitis Quality-of-Life Questionnaire (NRQLQ) in all patients
    - Standardised Asthma Quality-of-Life Questionnaire (AQLQ(S)) in asthmatic patients
    ; Health economic endpoints:
    - Number of working days lost due to grass pollen-induced allergy symptoms
    - Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS); Responder analysis on reactivity to CPT: one patient will be considered as a responder if the reactivity to CPT decreases between V1 and V6.; Responder analysis on CSMS over the peak pollen period and entire pollen season: one patient will be considered as a responder if the score is lower of at least 20% with respect to the median score observed in the placebo group; Safety and clinical tolerability endpoints will include:
    - Solicited adverse events:
    - Local reactions at the injection site (swelling and redness) after investigational product administration
    - Allergic systemic reactions after investigational product administration; Safety and clinical tolerability endpoints will include:
    - Unsolicited adverse events and serious adverse events; Safety and clinical tolerability endpoints will include:
    - Physical examinations and vital signs; Safety and clinical tolerability endpoints will include:
    - Laboratory investigations (haematology, clinical biochemistry, immunological parameters); Safety and clinical tolerability endpoints will include:
    - Use of rescue mediction during treatment phase
    CSMS durante l’intera stagione pollinica delle graminacee; RTSS nel periodo di picco e durante la stagione pollinica; RMS nel periodo di picco e durante la stagione pollinica; Sotto-punteggi dei sintomi (occhi, naso) nel periodo di picco e durante la stagione pollinica; “Giornate di benessere” (ovvero giorni senza assunzione di farmaci al bisogno) nel periodo di picco e durante la stagione pollinica; Nei pazienti asmatici: Sintomi polmonari nel periodo di picco e durante la stagione pollinica; Nei pazienti asmatici: Punteggio totale dei sintomi (TSS; la somma dei punteggi relativi a naso, occhi e polmoni) nel periodo di picco e durante la stagione pollinica; Nei pazienti asmatici: Uso di farmaci di soccorso per il sollievo dei sintomi dell’asma nel periodo di picco e durante la stagione pollinica; Risultati del test di provocazione congiuntivale (CPT); Questionari sulla Qualità della vita:
    - Questionario standardizzato sulla Qualità della vita nei pazienti affetti da rinocongiuntivite (RQLQ(S)) e Questionario sulla Qualità della vita notturna nei pazienti affetti da rinocongiuntivite (NRQLQ), in tutti i pazienti
    - Questionario standardizzato sulla qualità della vita (AQLQ(S)) nei pazienti asmatici; Endpoint farmacoeconomici:
    - Numero di giornate lavorative perse a causa dei sintomi indotti dall’allergia ai pollini delle graminacee
    - Perdita di produttività sul posto di lavoro dovuta ai sintomi indotti dall’allergia ai pollini delle graminacee, usando una scala analogica visiva (VAS); Analisi dei responder su reattività al CPT: un paziente sarà considerato responder se la reattività al CPT diminuisce tra la V1 e la V6; Analisi dei responder su CSMS nel picco del periodo pollinico e durante l’intera stagione pollinica: un paziente sarà considerato responder se il punteggio è inferiore di almeno il 20% rispetto al punteggio mediano osservato nel gruppo trattato con placebo; Gli endpoint relativi alla sicurezza e alla tollerabilità clinica includeranno:
    - Eventi avversi sollecitati
    - Reazioni locali al sito di iniezione (rigonfiamento e rossore) dopo la somministrazione del medicinale sperimentale
    - Reazioni allergiche sistemiche dopo la somministrazione del medicinale sperimentale; Gli endpoint relativi alla sicurezza e alla tollerabilità clinica includeranno:
    - Eventi avversi non sollecitati ed eventi avversi gravi; Gli endpoint relativi alla sicurezza e alla tollerabilità clinica includeranno:
    - Esame obiettivo e parametri vitali; Gli endpoint relativi alla sicurezza e alla tollerabilità clinica includeranno:
    - Esami di laboratorio (ematologia, biochimica clinica, parametri immunologici); Gli endpoint relativi alla sicurezza e alla tollerabilità clinica includeranno:
    - Utilizzo del farmaco di soccorso durante la fase di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the entire pollen season; during the peak and entire pollen season; during the peak and entire pollen season; during the peak and entire pollen season; during the peak and entire pollen season; during the peak and entire pollen season; during the peak period and the pollen season; during the peak period and the pollen season; at visit 1 and 6; at visit 6, 7 and 8; at visit 6, 7 and 8; at visit 6; during the peak and entire pollen season; at visit 2, 3, 4 and 5; visit 2 to visit 8; visit 1 to visit 8; visit 1, 6 and 8; visit 2, 3, 4 and 5
    durante l’intera stagione pollinica delle graminacee; nel periodo di picco e durante la stagione pollinica; nel periodo di picco e durante la stagione pollinica; nel periodo di picco e durante la stagione pollinica; nel periodo di picco e durante la stagione pollinica; nel periodo di picco e durante la stagione pollinica; nel periodo di picco e durante la stagione pollinica; nel periodo di picco e durante la stagione pollinica; alla visita 1 e 6; alla visita 6, 7 and 8; alla visita 6, 7 and 8; alla visita 6; nel periodo di picco e durante la stagione pollinica; alla visita 2, 3, 4 and 5; visita 2 a visita 8; visita 1 a visita 8; visita 1, 6 e 8; visita 2, 3, 4 e 5
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 654
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 654
    F.4.2.2In the whole clinical trial 654
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
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