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    Summary
    EudraCT Number:2013-000056-18
    Sponsor's Protocol Code Number:BTT-gpASIT007
    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:2013-02-04
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-000056-18
    A.3Full title of the trial
    Safety, clinical tolerability and immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to hay fever patients. A Phase IIa dose-escalation study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, clinical tolerability and immune activity of increasing doses of the investigational medicinal product gpASIT+TM administered under the skin to patients suffering from hay fever.
    A.4.1Sponsor's protocol code numberBTT-gpASIT007
    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 S.A.
    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 organisationInstitut für Medizinische Statistik, Informatik und Epidemiologie
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressLindenburger Allee 42
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50931
    B.5.3.4CountryGermany
    B.5.4Telephone number+492214783456
    B.5.5Fax number+492214783465
    B.5.6E-mailinformatik@imsie.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 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.3.11 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 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
    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.
    E.1.1.1Medical condition in easily understood language
    Treatment of patients who suffer from hay fever to grass pollen
    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 15.1
    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 in patients suffering from hay fever is the assessment of the safety and clinical tolerability of increasing doses of gpASIT+TM when administered by subcutaneous injections, in order to determine the maximal tolerated dose.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are the assessment of the immunogenicity of increasing doses of gpASIT+TM administered subcutaneously and the comparison of the reaction to Conjunctival Provocation Test (CPT) performed before and after treatment as well as at Visit V5
    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 18–70 years
    • The patients are in good physical and mental health according to his/her medical history and vital signs
    • Non-pregnant, non-lactating females with adequate contraception (see Annex XX.3)
    • Females unable to bear children must have signed the form for adequate contraceptive protection (see Annex XX.3) (i.e. tubule 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 (SAR) for the grass pollen season during at least the two previous years
    o A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction ≤ 2 mm
    o Specific IgE against grass pollen (IgE > 0.7 kU/l)
    o Patients treated with anti-allergic medication for at least 2 years prior to enrolment
    • In asthmatic patients:
    o Confirmed diagnosis of controlled asthma according to GINA-guidelines (GINA 2006)
    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
    • Patients being in any relationship or dependence with the Sponsor and/ or Investigator
    • Inability to understand instructions/ study documents
    • Patients with a history of hypersensitivity to the excipients of investigational products
    • Patients with partly controlled or uncontrolled asthma
    • Chronic asthma or emphysema, particularly with a FEV 1 <80% of the predicted value (ECSC)
    • Patients symptomatic to perennial inhalant allergens to which the subjects are regularly exposed.
    • Patients with a history of renal disease or chronic hepatic disease
    • Patients with malignant disease,
    • Patients with a know severe autoimmune disease and patients with a positive test to ANA, ANCA or ASCA
    • Patients with any chronic disease which may impair the patient’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
    • Patients requiring beta-blockers/ACE-inhibitors medication
    • Patients with any contraindication for the use of adrenaline
    • Patients with febrile illness (> 37.5°C, oral)
    • Patients with a known positive serology for HIV-1/2, HBV or HCV
    • 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 (see Annex XX.3)
    • Consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 3 weeks preceding the trial (screening visit)
    • Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007)
    • 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
    E.5 End points
    E.5.1Primary end point(s)
    The possible adverse reactions will be investigated by the systematic recording at predetermined time points of
    - general physical status, vital signs
    - solicited local adverse events, unsolicited adverse events, serious adverse events
    - haematological parameters
    - routine blood chemistry parameters
    - immunological analysis
    - inflammatory parameters
    - urinanalysis
    E.5.1.1Timepoint(s) of evaluation of this end point
    - general physical status, vital signs (visit 1 to 8)
    - solicited local adverse events, unsolicited adverse events, serious adverse events (visit 2 to 8)
    - haematological parameters (visit 1 and 8)
    - routine blood chemistry parameters (visit 1 and 8)
    - immunological analysis (visit 1 and 8)
    - inflammatory parameters (visit 1 and 8)
    - urinanalysis (visit 1 and 8)
    E.5.2Secondary end point(s)
    The secondary objectives of this trial are the assessment of the immunogenicity of increasing doses of gpASIT+TM administered subcutaneously and the comparison of the reaction to Conjunctival Provocation Test (CPT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Theses will be performed before and after treatment as well as at visit 6
    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 Yes
    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
    immunogenicity
    Immunogenität
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years0
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days42
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    No
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-09
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