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    Summary
    EudraCT Number:2007-005843-93
    Sponsor's Protocol Code Number:CYT006-AngQb 02
    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:2007-11-16
    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 number2007-005843-93
    A.3Full title of the trial
    A Double Blind, Randomized, Placebo Controlled, Parallel Group Phase IIa Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients with Mild to Moderate Essential Hypertension.
    A.4.1Sponsor's protocol code numberCYT006-AngQb 02
    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 nameCYT006-AngQb
    D.3.4Pharmaceutical form Suspension 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 codeCYT006-AngQb
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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 placeboSuspension 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
    Mild to moderate essential hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade I and II).
    • To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin- angiotensin system (RAS) biomarkers.
    • To explore the effect on blood pressure using ABPM.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140–179 mmHg and/or mean sitting office DBP = 90 –109 mmHg on 2 consecutive visits (screening and V1).
    • Daytime blood pressure above threshold for definition of hypertension in the screening ABPM measurement (SBP >130 mmHg and/or DBP >85 mmHg).
    • Stable baseline blood pressure confirmed on 2 consecutive visits (screening and V1). (Changes <20mmHg for sitting office SBP and <10mmHg for mean sitting office DPB).
    • Patients without current antihypertensive therapy. For patients on previous antihypertensive therapy, who can safely stop their medication, the screening period will be prolonged for a wash-out phase, not shorter than 2 weeks. The “screening” office blood pressure and ABPM should be assessed at the end of the wash-out period to confirm the inclusion criteria.
    • 18 to 69 years of age.
    • Male patients, or female patients without childbearing potential (postmenopausal - one year without menses, in case of doubts serum FSH should be determined and must be >30 U/mL) or surgically sterilized, documented).
    • Written informed consent must be signed before any study related procedure is performed including start of a wash-out from previous antihypertensive treatment.
    • Patient is willing and able to comply with all trial requirements and procedures.
    E.4Principal exclusion criteria
    • Patients with “very high added risk” according to ESH/ESC 2007 Guidelines for the Management of Arterial Hypertension, i.e. those with:
    - grade III hypertension (mean sitting office SBP ≥180mmHg and/or mean sitting DBP≥110mmHg)
    - history or presence of established cardiovascular or renal disease:
    - Ischemic stroke, cerebral hemorrhage, transient ischemic attack
    - Myocardial infarction, angina pectoris, coronary re-vascularization, heart failure
    - Clinically relevant left ventricular dysfunction (NYHA class II-IV)
    - Peripheral artery disease
    - Diabetic nephropathy
    • Electrocardiographic confirmed left ventricular hypertrophy (Sokolow-Lyon=sum of
    SV1+RV5 or V6>38 mm [3.8mV]
    • Increased plasma creatinin (M >115µmol/l, W >107 µmol/l).
    • Albumin/creatinine ratio in spot urine (M  22mg/g, W  31mg/g).
    • Diabetes mellitus type I, history, presence or new diagnosis of diabetes mellitus type II.
    • Fasting plasma glucose > 5.9 mmol/l
    • Body mass index (BMI) > 32
    • LDL cholesterol > 4.9 mmol/l
    • Triglycerides > 3.4 mmol/l
    • Postural hypotension at screening (fall of SBP from sitting to standing position >20 mmHg or DBP >10 mmHg) or clinical signs of orthostatic hypotension.
    • Patient requiring long-term usage of not allowed concomitant medication. For details, please refer to Section “Concomitant medication”.
    • Arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.
    • Known autoimmune disease.
    • Severe allergy.
    • Pregnancy or breastfeeding.
    • Women in childbearing age that are not surgically sterilized.
    • Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
    • Current diagnosis or history of malignancy.
    • Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
    • Drug or alcohol abuse within the past 2 years.
    • Presence or history of relevant cardiovascular, renal, hepatic, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator.
    • Any current or past disease or conditions (physical or mental) that would, in the opinion of the investigator, interfere with the study procedures or interpretation of the study data (e.g. workers in the night shift).
    • Previous participation in a clinical trial with a Qb based vaccine (CYT006-AngQb, CYT001-DerQb, CYT002-NicQb, CYT003-QbG10, CYT005-AllQbG10, CYT007-TNFQb and CYT009-GhrQb).
    • Use of an investigational drug within 3 months before enrolment, or planned use during the whole study period.
    • Possible dependency of the patient on sponsor and/or investigator.
    • Planned active immunization 2 weeks before or 2 weeks after any study medication vaccination.
    • Donation or loss ≥400 mL of blood within 8 weeks prior to dosing or major surgery within past 2 months.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical Endpoints
    •Ambulatory blood pressure monitoring (ABPM) For a primary analysis of ABPM, daytime will be defined as the time period between 06:00 a.m. and 22:00 p.m.
    • Standard office sitting and standing blood pressure readings .

    Pharmacodynamic Endpoints
    • Immune response: IgG titers of antibodies specific for either angiotensin II or Qb VLP
    • RAS biomarkers: Immunoreactive renin, angiotensin II, andaldosterone
    • Excretion of aldosterone and electrolytes (Na+, K+), creatinine Pharmacogenetic Evaluation

    Pharmacogenetic Evaluation
    • Pharmacogenetic analyses

    Safety Evaluations
    • Adverse events
    • Body temperature
    • 12 lead ECG
    • Body weight
    • Standard clinical laboratory evaluations (hematology, blood chemistry and urinalysis)
    • Calculated glomerular filtration from serum creatinine, calculated microalbuminuria from a spot urine sample
    • Inspection of Injection sites
    • Immune complexes and ANA (antinuclear antibodies)
    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 Yes
    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 concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) Yes
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    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 Decision2008-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-23
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