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    Summary
    EudraCT Number:2008-006927-29
    Sponsor's Protocol Code Number:CYT003-QbG10 11
    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:2008-12-15
    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 number2008-006927-29
    A.3Full title of the trial
    A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients with Persistent Allergic Asthma Bronchiale
    A.4.1Sponsor's protocol code numberCYT003-QbG10 11
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 name900 mcg QbG10
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeQbG10
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Adult Patients with Persistent Allergic Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this clinical Phase IIa trial is to assess the pharmacodynamic and clinical efficacy of QbG10 as disease modifying drug administered to patients with persistent allergic asthma.
    Furthermore, safety, tolerability and immunogenicity of QbG10 will be assessed.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Able and willing to provide written informed consent
    • Able and willing to complete all protocol requirements
    • 18 to 65 years of age
    • History of persistent asthma according to GINA 2007 guidelines whose symptoms requiring long-term treatment with ICS
    • Positive skin prick test to at least one aero-allergen and anamnestically confirmed to cause asthma symptoms. In case of doubt the allergic nature of the asthma must be confirmed by nasal provocation with the suspected allergen.
    • FEV1 >60% of predicted value
    • FEV1 improvement >=12% after inhaled beta2-agonist (400 µg salbutamol) at screening
    • Airway responsiveness to methacholine (PC20 <8 mg/mL) at screening (prior to run-in phase)
    • On stable therapy with ICS equivalent to a dose of ≥500 µg BDP daily (short-acting beta2-agonists (salbutamol) as needed may be used throughout the whole study)
    • Clinically stable asthma or sufficiently controlled asthma at screening and prior to treatment phase as indicated by <1.5 mean points in the Asthma Control Questionnaire (ACQ)
    • Female participants must meet one of the following criteria:
    - No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >30 U/mL and estradiol must be <54.7pg/mL), hysterectomy, bilateral oophorectomy, or tubal ligation
    - Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional month after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
    E.4Principal exclusion criteria
    • Use of oral corticosteroids within past 3 months
    • Hospitalization for asthma exacerbation within past 6 months
    • Uncontrolled asthma defined by ACQ ≥1.5 points at screening or prior to treatment phase
    • Intermittent or seasonal asthma not requiring ICS treatment
    • Regular use of long-acting beta2-agonists (LABA). All LABAs should be discontinued after informed consent and at least 48h prior to the screening procedure to ensure appropriate washout.
    • Smokers or quitters with a smoking history of >10 packyears (one package per day for 10 years)
    •Major surgery within 4 weeks prior to enrollment
    • Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, dermatological (in particular psoriasis), neurological and psychiatric (in particular depression) and ocular disease (in particular keratitis) as judged by the investigator. For psoriasis, family history should also be clean.
    • Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
    • Confirmed or suspected current infection with HIV, HBV, or HCV
    • Presence of active infectious disease as judged by the investigator
    • History of recurrent invasive streptococcal or staphylococcal infections, or known interleukin-1 receptor-associated kinase 4 (IRAK 4) deficiency
    • Active autoimmune diseases
    • Pregnancy (based on positive urine test at screening visit) or lactation
    • Female planning to become pregnant during the study period
    • Blood donation or loss of > 400 mL within 8 weeks prior to inclusion
    • Vaccination planned during study treatment period
    • History of abuse of alcohol or other recreational drugs
    • Lactose intolerance
    • Any specific immunotherapy (SIT) planned during the whole study period or any former SIT within the last three years.
    • Treatment with anti-IgE antibodies within past 6 months
    • Use of any investigational drug within 30 days before enrolment, or planned use during the whole study period
    • Previous participation in a clinical trial with a Qb-based vaccine
    • Possible dependency of the patient on sponsor and/or investigator
    E.5 End points
    E.5.1Primary end point(s)
    Inflammatory parameters (NO in exhaled air;Eosinophils in peripheral blood) and
    Clinical parameters (Methacholine test; Asthma questionnaire;
    Daytime/nighttime symptoms; Morning PEF; Use of rescue medication; Tolerance of ICS dose reduction; Skin prick test) serve as endpoints.
    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) 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.8.3 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 No
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2009-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-09
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