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    Summary
    EudraCT Number:2012-003070-39
    Sponsor's Protocol Code Number:CYT003-QbG1012
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-01
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-003070-39
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients with Moderate to Severe Allergic Asthma not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIb study to identify the best dose of test drug CYT003-QbG10 versus placebo, in patients with moderate to severe allergic asthma not sufficiently controlled on current standard treatment.
    A.3.2Name or abbreviated title of the trial where available
    CYT003-QbG1012
    A.4.1Sponsor's protocol code numberCYT003-QbG1012
    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 SponsorCytos Biotechnology AG
    B.1.3.4CountrySwitzerland
    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 supportCytos Biotechnology AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytos Biotechnology AG
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street AddressWagistrasse 25
    B.5.3.2Town/ cityCH-8952 Schlieren
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041447334747
    B.5.5Fax number0041447334740
    B.5.6E-mailinfo@cytos.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 nameCYT003-QbG10
    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.3.9.2Current sponsor codeCYT003-QbG10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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 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.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.3.2Product code CYT003-QbG10
    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.3.9.2Current sponsor codeCYT003-QbG10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 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.IMP: 3
    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.3.2Product code CYT003-QbG10
    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.3.9.2Current sponsor codeCYT003-QbG10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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 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
    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
    Allergic Asthma
    E.1.1.1Medical condition in easily understood language
    Allergic Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 study is to assess the therapeutic potential and safety/tolerability of QbG10 at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard inhaled corticosteroids (ICS) with or without long-acting β2 agonist (±LABA) therapy (Global Initiative for Asthma [GINA] steps 3 and 4)
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study. Note: All potential patients will sign an informed consent form (ICF) (Visit Scr/R1) before performing any study procedures.

    1. Able and willing to provide written informed consent
    2. Able and willing to complete all protocol requirements
    3. Between 18 to 65 years of age
    4. Persistent asthma with all of the following:

    • Present for at least 6 months according to GINA 2011 guidelines at Step 3 or 4 of treatment
    • Stable doses of controller therapy for at least 4 weeks prior to signing the ICF
    • Symptoms are not sufficiently controlled with medium to high doses of ICS (>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without LABA.
    • Asthma control questionnaire (ACQ) score ≥1.5.
    Note: Use of stable doses of other controller therapies according to GINA Steps 3 and 4 (leukotriene modifiers, sustained-release theophylline) are also acceptable provided doses are stable for 4 weeks prior to signing the ICF. Treatment with anti immunoglobulin E (IgE) antibodies (Xolair®) within the past 6 months will not be allowed (see exclusion criterion 18)

    5. Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits.
    6. Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening visit
    7. Forced expiratory volume in one second (FEV1) ≥40 to ≤90% of predicted value
    8. Reversibility of airway obstruction as demonstrated by:
    • FEV1 improvement of ≥12% , and
    • FEV1 improvement of ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent).

    If a patient does not meet reversibility criteria at the screening visit, reversibility can be retested once prior to run-in visit R2. Reversibility testing should occur after at least 6 hours of short-acting β2-agonist (SABA) withhold and at least 12 hours of LABA withhold. Reversibility can be performed after a longer LABA withhold at the discretion of the principal investigator.

    9. Patients meeting the contraception requirements detailed in the contraception requirements section.

    Contraception Requirements

    Male patients who can father a child & Female patients of childbearing potential must agree to use 2 highly effective methods of contraception with their female partners. Contraception must include at least 1 barrier method
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will be excluded from the study. Note: Any patient who fails during the screening visit may rescreen once with approval of the medical monitor.
    1. Failure to meet at least 80% compliance of use of the patient e-diary/PEF meter (AM3) at baseline visit, after initial instructions at the screening visit and, where necessary, additional training at the R2 run-in visit. The 80% AM3 compliance will be calculated over the 10 days prior to and including the morning session of BL/T1. A scheduled AM3 session will be considered to be compliant if a complete set of answers and at least 1 PEF measurement is available.
    2. Treatment or hospitalization for asthma exacerbation within past 2 months prior to signing the ICF. Patients who have an exacerbation during the screening visit/run-in period will be considered screen failures.
    3. Current use or use of systemic corticosteroids within past 2 months prior to signing the ICF.
    4. Current smokers.
    5. Ex-smokers with a smoking history of >10 pack years (e.g., 1 pack per day for 10 years).
    6. Major surgery within 4 weeks prior to enrollment or anticipated within the 12-week treatment period that might impact study procedures (e.g., spirometry)
    7. Presence or history of clinically relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
    8. Any malignancy within the previous 5 years except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or squamous cell carcinoma
    9. Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
    10. Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
    11. Presence of active infectious disease as judged by the investigator.
    12. Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus, and colitis ulcerosa.
    13. Pregnancy (based on positive urine test at screening visit) or lactation.
    14. Female planning to become pregnant during the study period.
    15. Patients with any history of abuse of alcohol or other recreational drugs.
    16. Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
    17. Use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period.
    18. Use of investigational or approved biologics including IgE antibodies (Xolair®) within the last 6 months.
    19. Previous participation in a clinical study with a virus-like particle (VLP) recombinantly expressed virus capsid shell (Qb)-based vaccine.
    20. Possible dependency of the patient on sponsor and/or investigator.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in ACQ score
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    E.5.2Secondary end point(s)
    • FEV1 (pre- and post-bronchodilator)
    • MiniAQLQ
    • Daytime/nighttime symptoms, use of reliever medication (SABA) and morning and evening PEF as self-reported by patients in e-diaries
    • Number of and time to asthma exacerbations
    • Additional exploratory analyses of the clinical state of patients may use information captured from diaries or eCRF such as:
    • An increase in the use of SABA defined as at least a doubling of the number of puffs from baseline (baseline will be defined as the average puffs per day over the last 10 days prior to the baseline visit [BL/T1]), or as an increase to 8 or more puffs of SABA over a 24 hour period
    • A 30% decrease from baseline (baseline will be defined as the average of best morning PEF values over the last 10 days prior to the baseline visit [BL/T1]) in PEF provided that the decrease persists for 2 or more consecutive days
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    Multicenter
    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 trial4
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Germany
    Hungary
    Israel
    Poland
    Russian Federation
    Ukraine
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial 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: 360
    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 No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 360
    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 Decision2013-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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