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    Summary
    EudraCT Number:2016-000557-13
    Sponsor's Protocol Code Number:ABT-hdmASIT001
    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:2016-04-05
    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 number2016-000557-13
    A.3Full title of the trial
    Assessment of safety and clinical tolerability of hdmASIT+TM administered subcutaneously in house dust mite-induced allergic rhinoconjunctivitis patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of safety and clinical tolerability of increasing doses of the investigational medicinal product hdmASIT+TM injected under the skin of patients suffering from perennial allergic rhinitis
    A.3.2Name or abbreviated title of the trial where available
    ABT-hdmASIT001_Phase IIa
    A.4.1Sponsor's protocol code numberABT-hdmASIT001
    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 SponsorASIT biotech 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 supportASIT biotech 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 und Bioinformatik, Uniklinik Köln
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Str. 62
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number+49221478 82932
    B.5.5Fax number+49221478 82945
    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 namehdmASIT+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 INNhdmASIT+TM
    D.3.9.1CAS number 8000045-20-7
    D.3.9.3Other descriptive nameALLERGENS, HOUSE DUST & MITE
    D.3.9.4EV Substance CodeSUB12784MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    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 house dust mite induced allergic rhinoconjunctivitis
    E.1.1.1Medical condition in easily understood language
    Treatment of house dust mite induced allergic rhinoconjunctivitis
    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 100000014962
    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 hdmASIT+TM treatment administered subcutaneously to patients with house dust mite related allergic rhinoconjunctivitis.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    To assess the impact on the immunological status of the patients and clinical impact of hdmASIT+TM comparing actively treated and placebo patients.
    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
    • Normal hepatic and renal function defined as per laboratory values of blood samplings according to local laboratory ranges
    • For females: non-pregnant, non-lactating with adequate contraception or females unable to bear children (i.e. 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 house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al 2001))
    A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to house dust mite Dermatophagoides pteronyssinus, positive control (histamine) wheal ≥ 3 mm, negative control (NaCl) wheal < 2 mm
    Specific IgE against house dust mite Dermatophagoides pteronyssinus > 0.7 kU/L
    Positive response to CPT with at least 30,000 SQ-E/mL of Dermatophagoides pteronyssinus solution
    • Having been treated with anti-allergic medication for at least 12 months prior to enrollment
    • For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value (ECSC)
    E.4Principal exclusion criteria
    Patients must not meet any of the following non-inclusion criteria in order to participate in this study:
    • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
    • Previous immunotherapy with house dust mite allergens within the last 5 years
    • Ongoing immunotherapy with house dust mite allergens or any other allergens
    • Being in any relationship or dependence with the Sponsor, CRO and/or Investigator
    • Inability to understand instructions/study documents
    • History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
    • History of hypersensitivity to the excipients of the investigational product or placebo
    • Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
    • Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient’s reference value (ECSC)
    • History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
    • Patients symptomatic to any inhaled allergens circulating during the study period (e.g. Mugwort, Ragweed, Alternaria, etc.) documented by history AND sIgE AND SPT
    • Patients symptomatic to any other perennial inhaled allergens (cat, dog) to which are regularly exposed and documented by history AND sIgE AND SPT
    • History of significant renal disease or chronic hepatic disease
    • Malignant active disease (ongoing or in within the past five years)
    • Diagnosed with severe autoimmune disease
    • 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.)
    • Intake of beta-blockers/acetylcholinesterase inhibitors medication
    • Intake of antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
    • Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
    • Having any contraindication for CPT testing
    • Having any contraindication for the use of adrenaline
    • Known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
    • Female who are pregnant, lactating, or of child-bearing potential and not using adequate contraceptive method
    • Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in the protocol with the exception of routine (previously prescribed) controller medication for asthmatic patients
    • Planned vaccination during the entire study period (e.g. against flu, pneumococcal, etc) – refer to the non authorized mediation section
    • No laboratory values clinically relevant greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit *
    • Patients for who the investigator believes will not comply with the study protocol (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)
    Safety and clinical tolerability of hdmASIT+TM treatment assessed by solicited adverse events: local reactions at the injection site (swelling and redness) and allergic systemic reactions after investigational product administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    Local reactions at the injection site (swelling and redness) and allergic systemic reactions after investigational product administration were evaluated after treatment at visit 2 to 9.
    E.5.2Secondary end point(s)
    Safety and clinical tolerability assessment of hdmASIT+TM treatment
    - Unsolicited adverse events and serious adverse events
    - Physical examinations and vital signs
    - Laboratory investigations (blood count, renal and liver function-related parameters, total IgG and total IgE)
    - Pulmonary functions for asthmatic patients

    Clinical Immunogenicity
    - Production of house dust mite specific immunoglobulins IgE, IgG and IgG4
    - Production of blocking antibodies (FAB assay)


    Clinical Impact
    - Conjunctival provocation test
    - Use of rescue medication during treatment phase
    E.5.2.1Timepoint(s) of evaluation of this end point
    Unsolicited adverse events and serious adverse events as well as physical examinations and vital signs will be done at Visit 2 to 11.
    Evaluation of blood count, renal and liver function-related parameters will be done at visit 1 and 10.
    Total IgG and IgE will be measured at visit 1, 10 and 11.
    Pulmonary functions of asthmatic patients will be assessed at visit 1 to 9.

    House dust mite specific IgE, IgG and IgG4 will be measured at visit 1, 8, 10 and 11.
    Blocking antibodies will be measured at visit 1, 8, 10 and 11 (optional).

    Conjunctival provocation testing at visit 1, 8, 10 and 11.
    Use of rescue medication will be documented after administration of study medication at visit 2 to 9.
    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
    Immunogenicity and clinical impact.
    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) 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 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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 40
    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 state40
    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 house dust mite induced allergic symptoms will be treated following this clinical 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 Decision2016-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-23
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