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    Summary
    EudraCT Number:2007-003516-62
    Sponsor's Protocol Code Number:CYT003-QbG10 08
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-10
    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 ConcernedEstonia - SAM
    A.2EudraCT number2007-003516-62
    A.3Full title of the trial
    Double-blind, Placebo-controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients with Perennial Allergic Rhinoconjunctivitis.
    A.4.1Sponsor's protocol code numberCYT003-QbG10 08
    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 nameCYT003-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 microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 900
    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 perennial allergic rhinoconjunctivitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039097
    E.1.2Term Rhinoconjunctivitis
    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 II trial is the proof of concept for CYT003-QbG10 (QbG10) as monotherapy in patients with perennial allergic rhinoconjunctivitis due to house dust mite and/or cat allergy. An active treatment arm will be compared to a placebo arm using conjunctival allergen challenge as efficacy readout parameter.
    E.2.2Secondary objectives of the trial
    Furthermore, safety and tolerability of the treatment will be assessed
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •18 to 65 years of age
    • Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens as evident from:
    - history of ≥ 2 years, and
    - positive skin prick test to house dust mite and/or cat allergen extract and
    - (CPT) score ≥8 at 5,000 (S)BE/mL and ≥2 at 500 (S)BE/mL of the ten-fold dilution series of house dust mite allergen solution ; if allergic to both house dust mites and cat, CPT should be performed with the allergen extract that caused the bigger wheal in the screening SPT
    • Patient did not perform an environmental intervention such as house dust mite remediation and/or cat removal to physically avoid the allergens he/she is allergic to within 2 months prior to his/her screening visit and patient does not plan to perform such an environmental intervention during study participation
    • Female participants must meet one of the following criteria:
    - No reproductive potential due to menopause, 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
    • Patient gave written informed consent
    • Patient is willing and able to comply with all trial requirements.
    E.4Principal exclusion criteria
    • Clinically relevant seasonal allergy/-ies which is/are expected to interfere with the patient’s study treatment schedule and/or assessments as judged by the investigator
    • Clinically relevant perennial allergy/-ies other than house dust mites or cat allergy
    • Contraindication for Conjunctival Provocation Test and/or Skin Prick Test
    • Use of any concomitant medication that could affect the patient’s study treatment response and/or allergic sensitivity or assessment results during the trial or that represents a contraindication for any study assessment as judged by the investigator
    • Any other specific immunotherapy (SIT) planned during the whole study period or any former specific immunotherapy (SIT) within the last five years
    • History of anaphylaxis
    • Contraindication for adrenaline/epinephrine as allergic shock rescue medication
    • Current diagnosis of asthma that requires permanent treatment with corticosteroids, or severe asthma according to guidelines
    • Any vaccination planned during study treatment period
    • Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator
    • Completed or ongoing treatment with tranquilizers or other psychoactive drugs for treatment of a psychiatric disease/condition
    • Presence of active infectious disease as judged by the investigator
    • History of recurrent invasive streptococcal or staphylococcal infections, or known IRAK 4 deficiency
    • Confirmed or suspected current infection with HIV, HBV, or HCV
    • Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
    • Pregnancy or lactation
    • Female planning to become pregnant during the study period
    • History of or present abuse of alcohol or other recreational drugs as judged by the investigator
    • Use of an 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)
    Efficacy

    Allergen challenge parameters:
    • Conjunctival provocation test (CPT) scores using a HDM-/cat-specific allergen dilution series.
    • Skin Prick Test (SPT) results using a HDM-/cat-specific allergen.
    Immunologic pharmacodynamic parameters:
    • anti-HDM/-cat IgG (total and subtypes IgG1, IgG2, IgG3 and IgG4).
    • anti-HDM/-cat IgE.
    • IgE (total).
    • Anti-Qb antibodies.
    Clinical parameters:
    • Disease scores and rescue medication use will be recorded by the patients in allergy diaries.
    • Quality of life (QoL) scores will be recorded in the CRF.


    Safety and tolerability

    • Adverse events and concomitant medications are recorded throughout the study.
    • Vital signs (blood pressure, heart rate, body temperature), are recorded at each visit.
    • ECG and physical examination are performed at screening and at study end.
    • Routine laboratory tests (hematology, blood chemistry, urinalysis) and test for CRP are performed at screening and at study end and during follow-up.
    • Antinuclear antibodies (ANA) tests are performed at visit 1 and at study end and during follow-up.
    • Injection sites will be inspected at each injection day, at the study end and at the follow-up visit 9 by the investigator; furthermore, the patients record local reactions at the injection site in a diary during the week following each injection.
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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 Decision2007-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-28
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