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    Summary
    EudraCT Number:2017-004616-19
    Sponsor's Protocol Code Number:ABT-gpCPT001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-04
    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 number2017-004616-19
    A.3Full title of the trial
    A dose-ranging clinical study to determine the range of grass pollen allergen (gpCPT+) concentrations to be used in a conjunctival provocation test to grade moderate to severe grass pollen allergic rhinoconjunctivitis patients.
    Eine Dosisfindungsstudie zur Bestimmung des Konzentrationsbereichs von gpCPT+ Gräserpollen zur konjunktivalen Provokationstestung bei Patienten mit mäßig stark bis stark ausgeprägter, durch Gräserpollen induzierter allergischer Rhinokonjunktivitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dose-ranging clinical study to determine the range of grass pollen allergen (gpCPT+) concentrations to be used in a conjunctival provocation test to grade moderate to severe hay fever in patients suffering from allergic inflammation of the conjunctiva which is caused by grass pollen allergens.
    A.4.1Sponsor's protocol code numberABT-gpCPT001
    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 organisationCRI - Clinical Research International Ltd.
    B.5.2Functional name of contact pointContract Research Organization
    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 number+4902217161330
    B.5.5Fax number+49022171613329
    B.5.6E-mailinfo@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 namegpCPT+
    D.3.4Pharmaceutical form Solution for provocation test
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular 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 Yes
    D.3.11.13.1Other medicinal product typegpCPT+ is not a diagnostic tool for seasonal allergic rhinoconjunctivitis (SAR). It is a standardized tool to measure the degree of grass pollen reactivity in SAR patients before and after AIT.
    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
    This clinical trial aims to evaluate a conjunctival provocation test (CPT) with the IMP gpCPT+ for the assessment and grading of grass pollen allergic rhinoconjunctivitis. Thus, a diagnostic solution will be tested and not medical condition or disease.
    Patients will be included in this trial who are suffering from grass pollen allergic rhinoconjunctivitis.
    E.1.1.1Medical condition in easily understood language
    This clinical trial aims to evaluate a conjunctival provocation test (CPT) using gpCPT+ for the assessment and grading of ARC. Thus, a diagnostic solution will be tested and not medical disease.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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 study is to determine in patients with moderate to severe grass pollen allergic rhinoconjunctivitis (ARC) the concentrations of grass pollen allergen at which cumulatively 50% +/- 10% of patients respond after local application in a conjunctival provocation test (CPT).
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are:
    • Assessment of safety and local tolerability of the conjunctival provocation test solutions
    • Determination of two concentrations of grass pollen allergens to which cumulatively 50%±10% of the patients respond in a CPT after administration of 50 µl
    • Determination of three concentrations of grass pollen allergens to which cumulatively 95% of the patients respond in a CPT after administration of 50 µl
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all subjects and patients:
    • Signed and dated Informed Consent Form by a legally competent patient
    • Female or male subjects aged 18–64 years
    • Being in good physical and mental health
    • For females: non-pregnant, non-lactating with adequate contraception as defined in the trial protocol in section 3.4.2 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))

    For non-allergic healthy subjects only (not for ARC patients):
    • Having no grass pollen induced allergy based on the following criteria:
    o No medical history of moderate to severe persistent allergic rhinoconjunctivitis (ARC) for the grass pollen season
    o A negative skin prick test (SPT - wheal diameter < 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm
    o Specific IgE against grass pollen mixture < 0.7 kU/L

    For ARC patients only (not for non-allergic, healthy subjects):
    • Having the diagnosis of grass pollen induced allergy based on all the following criteria:
    - A medical history of moderate to severe persistent seasonal ARC for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al, 2016))
    - Patients treated with documented use of anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
    - A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm
    - Specific Immunoglobulin E (IgE) against grass pollen mixture ≥ 0.7 kU/L

    • For patients with co-sensitization to ragweed or mugwort pollen allergens, the result of the SPT to ragweed or mugwort pollen has to be less (in mm wheal diameter) than the result to grass pollen
    E.4Principal exclusion criteria
    • Simultaneous participation in another clinical study or previous participation within 30 days before inclusion
    • Previous fully accomplished immunotherapy of 2 years or more with grass allergens within the last 5 years
    • Ongoing immunotherapy
    • Subjects being in any relationship or dependence with the Sponsor, clinical research organization and/or Investigator
    • Subjects for whom the Investigator believes he/she will not be able to comply with the study requirements, e.g. unreliable subjects, subjects with known alcoholism or drug abuse or with a history of a severe psychiatric disorder
    • Subjects symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
    • Subjects symptomatic to ragweed or mugwort pollen allergens or expected to develop allergic symptoms to mugwort or ragweed pollen allergens during the study period
    • Subjects with a documented history of IgE dependent anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
    • Subjects with partly controlled or uncontrolled asthma according to Global Initiative For Asthma (GINA) guidelines (GINA steps 3-5, 2017) and/or with asthma or Chronic Obstructive Pulmonary Disease (COPD) with confirmed forced expiratory volume in 1 second (FEV1) < 70% of the predicted value (ECSC) or with a peak expiratory flow (PEF) <70% of the individual optimum value
    • Subjects requiring any treatment with biologics, anti-IgE antibodies, mast cell stabilizers, anti-leukotriene agents
    • Subjects suspected of having allergies to the drugs used during CPT (e.g. topical antihistamines or eye drops containing benzalkonium)
    • Subjects with any contraindication for the use of adrenaline (in accordance with SmPC and including hyperthyroidism, uncontrolled hypertension) and/or requiring concomitant beta-blocking, angiotensin receptor blocker or angiotensin-converting-enzyme (ACE inhibitor) treatment
    • Subjects with (repeated) laboratory abnormalities greater than CTCAE grade 2 or more at screening or known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
    • Concomitant ongoing treatment with H1 anti-histaminic drugs or corticosteroids (oral, topical or nasal) except for skin ointments for mild conditions as eczema
    • Subjects with signs and symptoms of allergic conjunctivitis
    • Subjects with any known eye diseases except for anomalies of refraction
    • Subjects with any known ocular surface disease where IgE-mediated hypersensitivity is not involved (sicca syndrome, blepharitis, blepharo-conjunctivitis, urban eye syndrome, giant papillary conjunctivitis following intolerance to contact lenses or foreign bodies)
    • Subjects with any surgery to the eye within 6 months prior to CPT
    • Clinically relevant abnormalities in the 12-lead electrocardiogram (ECG)

    • Subjects with ongoing malignant disease
    • Subjects with an autoimmune disease and/or who are immunocompromised by medication or illness, or have received a vaccine or immunosuppressive medications within 30 days before study screening
    • Subjects with any severe systemic pathology, or chronic disease which may impair the subject’s ability to participate in the study (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.) including history of significant renal disease or chronic hepatic disease
    • Diagnosis of mastocytosis
    • Subjects requiring ongoing treatment with drugs with potent H1-antihistamine properties i.e. antipsychotic drugs and tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the cumulative percentage of CPT responders in concentrations used in a CPT solution at V2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit V2
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • Cumulative percentage of CPT responders at V3 to one of two concentrations selected according to the median (50% +/- 10%) reactivity observed at V2 and 1/9 of this concentration
    • Cumulative percentage of CPT responders at V3 to one of three concentrations selected according to the median (50% +/- 10%) reactivity observed at V2, 1/9 of this concentration and 9x of this concentration

    Further secondary endpoints are:
    • Number of patients responding at each dilution according to Riechelmann H et al, 2003 response staging
    • Number of patients in each response staging according to Riechelmann H et al, 2003

    Safety/Tolerability endpoints are:
    • Frequency of Adverse events (AEs) concerning, seriousness, intensity and relationship to the CPT procedure
    • Frequency and grading of local reactions and systemic reactions
    • Blood pressure, pulse rate, body temperature, and breathing frequency and change thereof
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for efficacy endpoints: V3
    Timepoint for further secondary endpoints: V2, V3
    Timepoint for Safety/Tolerability endpoints: V1, V2, V3
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 months3
    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: 76
    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 Yes
    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 state76
    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)
    None
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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