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    Summary
    EudraCT Number:2018-004472-35
    Sponsor's Protocol Code Number:DE_LODRO_GR19
    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:2018-12-13
    Trial results View 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 number2018-004472-35
    A.3Full title of the trial
    A single arm, open label, dose-escalation study of carbamylated monomeric grass pollen drops in patients with a history of allergic rhinoconjunctivitis
    Studio in aperto, singolo braccio, di incremento di dose, di gocce di allergoide monomerico carbamilato di polline di graminacee in pazienti con storia di rinocongiuntivite allergica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study conducted without a control (placebo or other drug) with the aim to establish the maximum tolerated dose of IMP in patient with grass pollen allergic rhinoconjunctivitis
    Studio senza utilizzo di un controllo (es. placebo o altro farmaco), in cui si cerca di stabilire la massima dose tollerata di un allergoide in pazienti che soffrono di rinocongiuntivite causata dal polline delle graminacee
    A.4.1Sponsor's protocol code numberDE_LODRO_GR19
    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 SponsorLofarma S.p.A.
    B.1.3.4CountryItaly
    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 supportLofarma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCD Pharma Srl
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressPiazza De Angeli, 7
    B.5.3.2Town/ cityMilano
    B.5.3.4CountryItaly
    B.5.4Telephone number0390289051076
    B.5.5Fax number0390289051088
    B.5.6E-mailinfo@cdpharma.it
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameLais® Graminacee
    D.3.4Pharmaceutical form Sublingual spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Graminacee pollen induced allergic rhinoconjunctivitis
    Rinocongiuntivite allergica indotta da pollini delle graminacee
    E.1.1.1Medical condition in easily understood language
    Graminacee pollen induced allergic rhinoconjunctivitis
    Rinocongiuntivite allergica indotta da pollini delle graminacee
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001738
    E.1.2Term Allergy
    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 is to assess the safety and clinical tolerability of Lais® Graminacee sublingual drops in patients with grass pollen-induced allergic rhinoconjunctivitis.
    L’obbiettivo primario di questo studio è quello di valutare la sicurezza e la tollerabilità di gocce sublinguali di Lais® Graminacee in pazienti con rinocongiuntivite allergica indotta dal polline delle graminacee
    E.2.2Secondary objectives of the trial
    Not applicable
    NA
    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
    • Being in good physical and mental health
    • Confirmed normal renal and liver function (including non-clinically significant deviations as defined per laboratory ranges)
    • For females: non-pregnant, non-lactating with adequate contraception or unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
    • Having the diagnosis of allergy based on all the following criteria:
    o A medical history of moderate to severe allergic rhinoconjunctivitis for grass pollen allergens for at least 2 years (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 allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal <2 mm
    o Specific IgE against grass pollen allergens =0.7 kU/L
    • For asthmatic patients: confirmed diagnosis of controlled, intermittent asthma according to Global Initiative for Asthma (GINA) guidelines with the following treatment (step 1): asthma symptoms are rare, there is no night waking due to asthma, no exacerbations in the last year and normal FEV1, use of short acting beta2-agonists as reliever medication as-needed, without the use of controller medication). If pulmonary function is tested by Peak Expiratory Flow, the patient has to achieve a PEF value =80% of the patient’s reference value.
    • Consenso Informato datato e firmato da parte del soggetto legalmente capace
    • Uomini o donne di età compresa tra 18–64 anni
    • Essere in buono stato di salute fisico e mentale
    • Avere una conferma di normale funzionalità renale ed epatica (compresa la assenza di deviazioni non-clinicamente significative rispetto ai range di laboratorio)
    • Per le donne: non essere in stato di gravidanza o allattamento, seguire una adeguata terapia anticoncezionale o non essere in grado di avere figli (es. sterilizzazione tubarica, isterectomia o post-menopausa (definita come un minimo di un anno dall’ultima mestruazione))
    • Avere una diagnosi di allergia sulla base dei seguenti criteri:
    o Una storia clinica di rinocongiuntivite allergica moderata o severa agli allergeni dei pollini delle graminacee da almeno 2 anni (definizione di severità dell’allergia secondo ARIA (Bousquet et al., 2001))
    o Un prick test cutaneo positivo (SPT, diametro del pomfo =3 mm) agli allergeni dei pollini delle graminacee, controllo positivo (istamina) pomfo =3 mm, controllo negativo (NaCl) pomfo <2 mm
    o IgE specifiche verso gli allergeni dei pollini delle graminacee =0.7 kU/L
    • Per i pazienti asmatici: diagnosi confermata di asma controllato, intermittente secondo le linee guida del Global Initiative for Asthma (GINA) con i seguenti trattamenti (step 1): sintomi dell’asma sono rari, assenza di risvegli notturni dovuti all’asma, assenza di esacerbazioni nell’ultimo anno e FEV1 normale, uso di beta2-agonisti a breve durata di azione come farmaci di sollievo al bisogno senza l’utilizzo di terapie di controllo). Se la funzionalità polmonare è valutata con il Picco di Flusso Espiratorio, il soggetto deve raggiungere un valore di PEF =80% dei valori di riferimento del paziente
    E.4Principal exclusion criteria
    • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
    • Previous immunotherapy with grass pollen allergens within the last 5 years
    • Ongoing immunotherapy with grass pollen allergens or any other allergens
    • Being in any relationship with or dependence on the Sponsor, CRO and/or Investigator
    • Inability to understand instructions/study documents
    • History of severe systemic reactions and/or anaphylaxis to food (e.g. peanut, seafood), Hymenoptera venom (e.g. bee, wasp stings), medication (e.g. penicillin), etc.
    • History of hypersensitivity to the excipients of the investigational product
    • Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
    • Chronic asthma or emphysema, i.e. FEV1 <80% of the patient’s reference value or PEF <80% of the patients´ individual optimal value
    • Respiratory tract infection or exacerbation of asthma within 4 weeks before the screening
    • Patients symptomatic to any seasonal inhaled allergens circulating during the study period (e.g. birch, hazel, parietaria) confirmed by medical history and SPT
    • Patients symptomatic to any perennial inhaled allergens (e.g. cat, dog, mites), to which the patients are regularly exposed during the study period, confirmed by medical history and SPT
    • Infections in the oral cavity with severe symptoms
    • Oral inflammation or wounds
    • History of significant renal disease or chronic hepatic disease
    • Malignant active disease (ongoing or within the five past years)
    • Severe autoimmune disease
    • Immune defects including immunosuppression, immunopathies
    • Vaccination, use of systemic immunosuppressive medications (e.g. methotrexate or cyclosporine A) or a blood transfusion one month before screening
    • Contemporanea partecipazione ad altri studi clinici o partecipazione nei 30 giorni precedenti l’inclusione
    • Precedente immunoterapia con allergeni di polline di graminacee negli ultimi 5 anni
    • Terapia in corso con allergeni di polline di graminacee o con altri allergeni
    • Avere una relazione di qualsiasi genere con lo Sponsor o il medico sperimentatore
    • Incapacità di comprendere le istruzioni e i documenti di studio
    • Storia clinica di reazioni sistemiche severe e/o anafilassi da cibo, da veleno di Imenotteri (e.g. punture di api e vespe), da farmaci (e.g. penicillina), etc.
    • Storia di ipersensibilità agli eccipienti del farmaco sperimentale e/o del placebo
    • Asma persistente da lieve a severo, parzialmente controllato o non controllato secondo le linee guida GINA (GINA 2014)
    • Asma cronico o enfisema, con FEV1 <80% del valore di riferimento del paziente o PEF <80% del valore ottimale del paziente
    • Infezioni del tratto respiratorio o esacerbazioni asmatiche nelle 4 settimane precedenti lo screening
    • Soggetti sintomatici a qualsiasi allergene stagionale presente nel periodo dello studio (es. betulla, nocciolo, parietaria) confermato dalla storia clinica e dal SPT
    • Soggetti sintomatici a qualsiasi allergene inalato perenne (es. cane, gatto, acaro), a cui il soggetto è regolarmente esposto durante il periodo di studio, confermato dalla storia clinica e dal SPT
    • Infezioni del cavo orale con sintomi severi
    • Infiammazioni o lesioni orali
    • Storia clinica di patologie renali ed epatiche significative
    • Patologie maligne attive (in corso o nei cinque anni precedenti)
    • Patologie autoimmuni severe
    • Difetti immunitari compresa immunosoppressione e immunopatie
    • Vaccinazione, utilizzo di farmaci immunosoppressivi sistemici (es. metotrexato di ciclosporina A) o trasfusione di sangue nel mese precedente lo screening
    E.5 End points
    E.5.1Primary end point(s)
    Safety and clinical tolerability will be assessed by:
    • Solicited adverse events including local reactions at the administration site (oropharyngeal and gastrointestinal symptoms) and systemic allergic reactions after investigational medicinal product administration
    La sicurezza e la tollerabilità verranno valutate attraverso:
    • Comparsa di eventi avversi incluse reazioni locali al sito di somministrazione (sintomi orofaringei e gastrointestinali) e reazioni allergiche sistemiche dopo la somministrazione del farmaco in studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    49 days
    49 giorni
    E.5.2Secondary end point(s)
    Safety and clinical tolerability will also be assessed by:
    • Unsolicited adverse events
    • Proportion of patients who reached the maximum dose
    • Use of rescue medication during treatment phase
    • Physical examinations and vital signs
    • Laboratory tests (blood count, renal and liver function parameters)
    • Pulmonary function for asthmatic patients
    La sicurezza e la tollerabilità verranno valutate anche attraverso:
    • Eventi avversi non sollecitati
    • Numero di pazienti che raggiungono la dose massima
    • Utilizzo di terapie di supporto durante la fase di trattamento
    • Esame fisico e segni vitali
    • Esami di laboratorio (emocromo, parametri di funzionalità renale ed epatica)
    • Funzionalità polmonare nei pazienti asmatici
    E.5.2.1Timepoint(s) of evaluation of this end point
    49 days
    49 giorni
    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 No
    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 No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.7Trial 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
    LPLV
    LPLV
    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 months6
    E.8.9.1In the Member State concerned 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: 30
    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 state30
    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)
    will be trated according to the normal clinical practice
    Saranno seguiti in accordo alla normale pratica clinica
    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 Decision2019-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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