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    Summary
    EudraCT Number:2017-003063-34
    Sponsor's Protocol Code Number:GSDL_DE_17
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-01
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-003063-34
    A.3Full title of the trial
    A double-blind, placebo-controlled dose-escalation study of carbamylated monomeric tree pollen drops in patients with a history of allergic rhinoconjunctivitis.
    Eine doppelblinde, placebo-kontrollierte Dosis-Eskalation-Studie mit carbamylierten momomeren Baum-Pollen Tropfen bei Patienten mit einer allergischen Rhinokonjunktivitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled study with increasing doses of chemically modified tree pollen drops in patients suffering from allergic
    inflammation of the conjunctiva and rhinitis which are caused by tree pollen allergens.
    A.4.1Sponsor's protocol code numberGSDL_DE_17
    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 organisationCRI - Clinical Research International Ltd.
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressGenter Str. 7
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50672
    B.5.3.4CountryGermany
    B.5.4Telephone number00491722056230
    B.5.5Fax number00490221 71613329
    B.5.6E-mailmanagement@cri-ltd.de
    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 nameLais Frühblüher sublingual Drops
    D.3.2Product code Lais Frühblüher sublingual Drops
    D.3.4Pharmaceutical form Oromucosal drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOromucosal drops
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of tree pollen-induced allergic rhinoconjunctivitis
    E.1.1.1Medical condition in easily understood language
    Treatment of Patients who suffer from rhinoconjunctivitis due to tree pollen allergy
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    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 trial is to assess the safety and clinical tolerability of Lais® Frühblüher sublingual drops in patients with birch pollen-induced allergic rhinoconjunctivitis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to assess
    •the impact on the immunological status by comparing actively treated and placebo patients
    •the clinical impact with regard to conjunctival reactivity by comparing actively treated and placebo patients based on the reduction of conjunctival tissue reactivity following Conjunctival Provocation Test (CPT)
    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 signifcant 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:
    • A medical history of moderate to severe allergic rhinoconjunctivitis for birch pollen allergens for at least 2 years (definition of allergy severity according to ARIA (Bousquet et al., 2001))
    • A positive skin prick test (SPT, wheal diameter ≥3 mm) to birch pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm
    • Specific IgE against birch pollen allergens (Bet v1) ≥0.7 kU/L
    • Positive response to conjunctival provocation test with at least a 1/10 dilution from a birch allergen provocation test stock solution
    • Being treated with anti-allergic medication for at least 2 seasons prior to enrolment
    • 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.
    E.4Principal exclusion criteria
    • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
    • Previous immunotherapy with birch pollen allergens within the last 5 years
    • Ongoing immunotherapy with birch 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 or placebo
    • 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.hazel) 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
    • Moderate to severe oral allergy syndrome caused by tree pollen-food cross-reactivity
    • 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
    • General inflammatory, severe, acute or chronic inflammatory diseases
    • Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
    • Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
    • Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
    • Use of systemic beta-blockers
    • Active tuberculosis
    • Contraindication for the use of adrenaline (including hyperthyroidism)
    • Contraindication for CPT (eye diseases except for anomalies of refraction, active allergic conjunctivitis, contact lenses, antiallergic therapy)
    • Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
    • Females who are pregnant, lactating, or of child-bearing potential and not using adequate contraceptives
    • Use of corticosteroids (oral, topic or nasal) or anti-histaminic drugs before screening visit. Exception made for routine medication for asthma control in asthmatic patients
    • Planned vaccination during the study (e.g. against flu, pneumococae, etc.)
    • Clinically relevant laboratory values, i.e. grade ≥2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007)
    • Patients, who the Investigator believes will not comply with the study protocol (patients with alcohol/drug abuse, history of serious psychiatric disorder, or who unwilling to give informed consent or to abide by the requirements of the protocol)
    E.5 End points
    E.5.1Primary end point(s)
    Safety and clinical tolerability of Lais tree pollen sublingual drops treatment will be assessed by:
    •Solicited adverse events including local reactions at the administration site (oropharyngeal and gastrointestinal symptoms) and systemic allergic reactions after investigational product administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Solicited adverse events including local reactions at the administration site (oropharyngeal and gastrointestinal symptoms) and systemic allergic reactions as well as unsolicited adverse events will be evaluated after investigational product administration over the time frame of the entire treatment period between V2 and V6.
    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

    Clinical immunogenicity endpoints will include:
    •Production of Bet v1 specific IgE, IgA and IgG4

    Clinical impact endpoints will include:
    •Conjunctival provocation test
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportion of patients who reached the maximum dose and the use of rescue medication will be evaluated over the time frame of the entire treatment period between V2 and V6.
    Physical examinations and vital signs will be evaluated over all visits (V1 - V6/V6b).
    Pulmonary function in asthmatic patients right before the intake of IMP will be evaluated over the time frame of the entire treatment period betwenn V2 and V6.
    Evaluation of blood count, renal and liver function-related parameters will be done at visits V1 and V6.
    Birch pollen specific Ige, IgA and IgG4 will be measured at visits V1 and V6.
    Conjunctival provocation testing will be evaluated at visits V1 and V6 or V6b.
    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 Yes
    E.6.13.1Other scope of the trial description
    clinical tolerability
    clinical impact of the therapy
    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 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 Yes
    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) Yes
    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 concerned6
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 48
    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 state48
    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)
    Patients with ongoing symptoms due to tree pollen-induced rhinoconjunctivitis will be treated following this trial by their physician according to the guidelines.
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
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