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    Summary
    EudraCT Number:2011-004486-33
    Sponsor's Protocol Code Number:BTT-gpASIT006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-10-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-004486-33
    A.3Full title of the trial
    Safety, clinical tolerability and immunogenicity of gpASIT+TM administered subcutaneously to hay fever patients either alone or in presence of DnaK immunoregulating adjuvant.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study with a new medication (grass pollen - ASIT+TM or gpASIT+TM) administered subcutaneously with or without the new immunoregulating agent (DnaK) for the treatment of hay fever.
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberBTT-gpASIT006
    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
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Sigma
    B.5.2Functional name of contact pointMarc Thomson
    B.5.3 Address:
    B.5.3.1Street AddressRue du Béguignage 24
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number322217 43 99
    B.5.5Fax number322217 43 99
    B.5.6E-mailmt@medicalsigma.com
    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+™
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive namepollen peptides (400 µg/mL)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    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+™/DnaK
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive namepollen peptides + bacterial heat shock protein (400 µg/mL each)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    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 hay fever
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019170
    E.1.2Term Hay fever
    E.1.2System Organ Class 10021428 - Immune system disorders
    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 gpASIT+™ when administered by subcutaneous injection alone or with DnaK, an immunoregulating adjuvant, until the end of the grass pollen season (Visit 10, July 2012).
    E.2.2Secondary objectives of the trial
    • The secondary objective of this trial are:
    - the assessment of the immunogenicity of gpASIT+™ administered subcutaneously alone or in the presence of DnaK as adjuvant.
    - the assessment of the adjuvant effect of DnaK on reduction of symptom scores and rescue medication intake and on improvement of the quality of life of the subjects during the subsequent grass pollen season.
    - the evolution of immunological, inflammatory and grass pollen- and DnaK-specific immunoglobulins during a 12-month follow-up period (from baseline to Visit 11, January 2013)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject has given written informed consent
    • Age between 18 and 50 years
    • The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
    • Male or non-pregnant, non-lactating female
    • Females unable to bear children must have documentation of such in the CRF (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) during 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
    o Specific IgE against grass pollen (IgE > 0.7 kU/l) [using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213)]
    • Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011)
    E.4Principal exclusion criteria
    • Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years
    • Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months
    • A history of hypersensitivity to the excipients of investigational products
    • Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week)
    • Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment
    • Subjects with a VC < 80% and a FEV1 < 70% of predicted value at the screening visit.
    • Subjects symptomatic to perennial inhalant allergens who should need antihistamine drug or systemic corticoids to relieve allergic symptoms during the treatment period.
    • Subjects with documented evidence of chronic sinusitis (as determined by Investigator)
    • Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
    • Subjects with a history of renal disease or chronic hepatic disease
    • Subject with malignant disease, autoimmune disease
    • Any chronic disease, which may impair the subject’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
    • Subjects requiring beta-blockers medication
    • Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
    • Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial (screening visit)
    • Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial (screening visit)
    • Subject with febrile illness (> 37.5°C, oral)
    • A known positive serology for HIV-1/2, HBV or HCV
    • Subjects that are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
    • Receipt of blood or a blood derivative in the past 6 months preceding trial entry
    • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (e.g. OCs, IUD, V-rings and contraceptive implants, condoms…)
    • Any condition which could be incompatible with protocol understanding and compliance
    • Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
    • Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
    • Subjects without means of contacting the Investigator rapidly in case of emergency, or not able to be contacted rapidly by the Investigator
    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 (heart rate and blood pressure),
    • solicited local adverse events (reactions at the injection site), unsolicited adverse events, serious adverse events,
    • haematological parameters (haemoglobin, haematocrit, Red Blood Cell (RBC), White Blood Cells (WBC) including differential counts and platelets),
    • routine blood biochemistry parameters,
    • DnaK-specific immunoglobulins analysis,
    • immunological analysis (total IgE and IgG levels, anti-nuclear antibodies (ANA) and Rheumatoid Factor (RF)),
    • inflammatory parameters (C-Reactive protein (CRP)),
    • DnaK-specific IgG.
    • urinalysis,
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Physical status, vital sign : Visit 1 to 10; - Solicited local adverse events : all visits during treatment (Visit 2 to 6); - Unsolicited adverse events: from Visit 2 to 10; - Serious adverse events : from Visit 2 to 11; - Blood analysis for safety assessment (haematology, routine biochemistry) at screening Visit (Visit 1), after treatment (Visit 7) and at the end of the study (Visit 8 and Visit 10)
    - Urinalysis : screening Visit (Visit 1), after treatment (Visit 7) and at the end of the study (Visit 10); - Immunological analysis (total IgE and IgG levels, anti-nuclear antibodies (ANA) and Rheumatoid Factor (RF)): Visit 1, 7, 10 and 11
    - inflammatory parameters (C-Reactive protein (CRP)): Visit 1, 7, 10 and 11
    - DnaK-specific IgG: Visit 1, 7, 10 and 11

    E.5.2Secondary end point(s)
    The secondary objective of the trial are:
    • The monitoring of the changes in grass pollen allergen-specific IgE, IgG, IgG4, IgA antibody concentrations in gpASIT+TM treated and gpASIT+TM / DnaK treated subjects. This will be analyzed first from baseline to the end of the grass pollen season. A second analysis will cover a 12-month reporting period.
    • The adjuvant effect of DnaK on the reduction of symptom scores and the rescue medication intake and on the improvement of the quality of life of the subjects assessed by recording on diary cards, the daily allergic symptom score, the daily rescue medication intake during the pollen season following treatment and by answering a validated rhinoconjunctivitis quality-of-life questionnaire (RQLQ).
    • As exploratory endpoints, the production of DnaK-specific IgE, IgA and IgM and the characterization of the different isotypes of DnaK-specific IgG (IgG1 to IgG4). The production of blocking antibodies will as well be assessed in the serum of the gpASIT+TM / DnaK treated subjects in comparison with gpASIT+TM treated subjects.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1, Visit 7, Visit 8 and at Visit 10 in a first analysis: determination of grass pollen specific IgE, IgG, IgG4, IgA and blocking antibodies and the production of DnaK-specific IgE, IgA and IgM and the characterization of the different isotypes of DnaK-specific IgG (IgG1 to IgG4) (exploratory).
    Visit 1, Visit 7, Visit 8, Visit 10 and Visit 11 in a second analysis: same determination as described in the first analysis.

    During (V9) and after the pollen season (V10):Symptom/
    Rescue Medication Diary cards + Quality-of-Life Questionnaire
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    Effect of DnaK on symptoms, rescue medication intake and Quality of Life
    immunogeniciteit
    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 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) Yes
    E.8.2.2Placebo No
    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 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 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
    The end of the trial will be when the last subject has performed his/her last visit according to the trial protocol
    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 months12
    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: 24
    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 state24
    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
    Neen
    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 Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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