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    Summary
    EudraCT Number:2017-002911-33
    Sponsor's Protocol Code Number:ABT-gpASIT011
    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:2018-07-09
    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 number2017-002911-33
    A.3Full title of the trial
    A multicentre, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergy in comparison with a placebo
    A.4.1Sponsor's protocol code numberABT-gpASIT011
    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 organisationASIT biotech S.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Ariane 5
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322264 0390
    B.5.5Fax number+322264 0399
    B.5.6E-mailinfo@biotech.be
    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 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 INNgpASIT+™
    D.3.9.3Other descriptive namePOLLEN PEPTIDES
    D.3.9.4EV Substance CodeSUB168148
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 seasonal grass pollen-induced rhinoconjunctivitis
    E.1.1.1Medical condition in easily understood language
    Treatment of hey 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 20.0
    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
    To demonstrate the clinical efficacy of grass pollen-ASIT+™ (gpASIT+™) following subcutaneous administration to patients suffering from grass pollen-induced allergic rhinoconjunctivitis, as assessed with the combined symptom and medication score (CSMS) during the peak of the 2019 grass pollen season.
    E.2.2Secondary objectives of the trial
    • To confirm the clinical efficacy of gpASIT+™ as assessed with the CSMS during the entire 2019 grass pollen season;
    • To confirm the clinical efficacy of gpASIT+™ as assessed with the Rhinoconjunctivitis Total Symptom Score (RTSS) and subscores, the Rescue Medication Score (RMS) and the rate of “well days”, during the 2019 grass pollen season (both peak and entire season);
    • To confirm the safety and clinical tolerability of gpASIT+™ treatment;
    • To confirm the induction of key immunological effects in serum after treatment with gpASIT+™;
    • To assess patients’ quality of life and the health economics impact of treatment with gpASIT+™ during the pollen season.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Female or male patients aged 18 to 64 years (inclusive);
    2) Signed and dated Informed Consent Form (ICF) by a legally competent patient;
    3) Good physical and mental health according to medical history, physical examination and vital signs;
    4) Female patients who are:
    a. Not of childbearing potential, defined as: amenorrhea or post-menopausal (natural spontaneous amenorrhea for at least 12 months, or at least 6 weeks following surgical menopause), OR
    b. Naturally or surgically sterile (hysterectomy; bilateral salpingectomy or oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study screening), OR
    c. Non-pregnant, non-lactating with negative blood pregnancy test at the Screening visit and using at least one of the following contraceptive methods:
    i. Stable hormonal contraceptive for ≥90 days prior to the study (if <90 days prior to the study, additional use of a double barrier method is required until 90 days are reached) and for ≥3 weeks after the final injection, OR
    ii. Placement of an intrauterine device (IUD) or intrauterine hormone-releasing
    system, OR
    iii. Successful male sterilisation of the sole sexual partner (patient must verbally
    confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided), OR
    iv. True abstinence when in line with the preferred and usual lifestyle of the patient. Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception.
    5) Allergy diagnosis:
    a. A clinical history of moderate to severe grass pollen-induced SARC for at least 2 pollen seasons, requiring treatment with either antihistamines or nasal corticosteroids during the 2017 and 2018 grass pollen seasons and with symptoms interfering with usual daily activities or with sleep, as defined according to Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis (Bousquet et al. 2001; Brozèk et al. 2017, see Chapter VIII.3.2) AND
    b. A positive SPT (wheal diameter ≥3 mm) to grass pollen mixture, histamine wheal ≥3 mm, sodium chloride (NaCl) control reaction <2 mm AND
    c. Specific IgE against grass pollen ≥0.7 kU/L.
    6) For asthmatic patients, confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA; 2018) guidelines (Steps 1 to 3, see Chapter VIII.3.2).
    E.4Principal exclusion criteria
    1) Diagnosis of mastocytosis;
    2) Previous (within the last 5 years) immunotherapy with grass allergens;
    3) Ongoing immunotherapy with grass allergens or any other allergens;
    4) Patients with any history of anaphylaxis due to any cause;
    5) Patients with a history of hypersensitivity to the excipients of the investigational product;
    6) Patients with a forced expiratory volume in 1 second (FEV1) <80% of the predicted value (European Community for Steel and Coal [ECSC]) or with a peak expiratory flow (PEF) <70% of the individual optimum value at the Screening visit
    7) History of being intubated with mechanical ventilator support or in intensive care unit for asthma at any point in the patient’s life;
    8) History of emergency visit or hospital admission for asthma in the previous 12 months;
    9) Clinical history of moderate to severe allergic rhinitis, as defined according to the ARIA classification of rhinitis, due to tree pollen near or overlapping the grass pollen season;
    10) Clinical history of moderate to severe allergic rhinitis as defined according to the ARIA classification of rhinitis caused by an allergen to which the participant is regularly exposed;
    11) Patients with a history of significant renal disease or chronic hepatic disease;
    12) Patients with a malignant disease;
    13) Patients with history of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease or immunodeficiency, or with 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.);
    14) Patients requiring concomitant medications such as beta-blocking, angiotensin receptor antagonist or angiotensin-converting enzyme inhibitor treatment; antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.); anti-IgE antibodies, mast cell stabilisers, anti-leukotriene agents or anti-interleukin treatment (e.g. anti-interleukin 5); corticosteroids (oral, topical or
    nasal); or H1 anti-histaminic drugs;
    15) Patients with any contraindication for the use of adrenaline;
    16) Patients with (repeated) laboratory abnormalities greater than Common Terminology Criteria for Adverse Events Grade 2 or higher at screening;
    17) Patients with known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus;
    18) Patients having received a vaccine, corticoids or immunosuppressive medications with significant systemic effect within 1 month before trial entry;
    19) Patients being in any relationship with or being dependent on the Sponsor, Contract Research Organisation (CRO) and/or Investigator;
    20) Inability to understand instructions, attend planned visits and/or complete study documents or assessments, including unreliable patients such as those with known alcoholism or drug abuse or with a history of a severe psychiatric disorder, as well as patients unwilling to give informed consent or to abide by the requirements of the protocol;
    21) Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion;
    22) Patients who have been committed to an institution by virtue of an order issued by either the judicial or the administrative authorities.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the average daily CSMS collected during the peak of the grass pollen season. The daily CSMS is the sum of the daily symptom score and the daily RMS calculated from the data recorded in the eDiary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the peak of the grass pollen season.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are:
    • CSMS over the entire grass pollen season;
    • RTSS (i.e. the sum of ESS and NSS) over the peak period and the entire grass pollen season; RMS over the peak period and the entire grass pollen season;
    • Symptom subscores (ESS and NSS) over the peak period and the entire grass pollen season;
    • TSS (the sum of the ESS, NSS and lung symptom score) over the peak period and the entire grass pollen season (in asthmatic patients only);
    • Use of rescue medication to relieve asthma symptoms over the peak period and the pollen season;
    • Number (%) of “well days” over the peak period and the entire grass pollen season;
    • RQLQ(S);
    • PGE assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the peak period and the entire pollen season
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 624
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 624
    F.4.2.2In the whole clinical trial 624
    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)
    Standard of care
    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 Decision2018-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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