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    Summary
    EudraCT Number:2007-006741-40
    Sponsor's Protocol Code Number:CNIC002A2201
    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:2008-04-10
    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 ConcernedGermany - PEI
    A.2EudraCT number2007-006741-40
    A.3Full title of the trial
    A double blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety, tolerability and immunogenicity of repeated s.c administrations of 100µg NIC002 vaccine in cigarette smokers who are motivated to quit smoking
    A.4.1Sponsor's protocol code numberCNIC002A2201
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountryUnited Kingdom
    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.3.2Product code NIC002
    D.3.4Pharmaceutical form Powder for 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 codeNIC002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    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
    Smokers
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that treatment with NIC002 increases the 4-week rate of continuous abstinence from smoking between weeks 8 and 12 inclusive compared with placebo
    E.2.2Secondary objectives of the trial
    •To further evaluate clinical efficacy of NIC002 in smokers willing to quit, as determined by:
    -the rate of continuous abstinence from smoking for weeks 8 through 26, weeks 26 though 52 and weeks 8 through 52
    -the point-prevalence of abstinence assessed at week 12, 26, 39 and 52, based on self-reported smoking status
    •To evaluate safety and tolerability (local and systemic) of s.c. NIC002 in healthy smokers by monitoring of clinical signs and symptoms
    •To determine immunogenicity of s.c. NIC002 by determination of titers and titer profiles of specific anti-nicotine antibodies (Ab) in serum
    •To investigate the relationship between specific anti-nicotine antibodies titers in serum and clinical efficacy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Healthy male and female smoking subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, spirometry and laboratory tests at screening. Subjects with medically managed hypertension or hypercholesterolemia may be included in the study.
    2.Subjects must be smoking 10 or more cigarettes per day during the past 12 month prior to the week 0, with no period of abstinence longer than 7 days in the last 3 months prior to week 0.
    3.The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening.
    4.The Fagerström Test for Nicotine Dependence (FTND) should indicate at least a moderate level of nicotine dependence which is a score of 5 or above at screening.
    5.Subjects must agree to quit smoking by TQD.
    6.At screening vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three (3) minutes, Investigators can be guided by the following ranges:
    systolic blood pressure, 90-140 mm Hg
    diastolic blood pressure, 50-90 mm Hg
    pulse rate, 45 - 100 bpm
    7.Female subjects must be postmenopausal with no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening.
    OR
    Female subjects must have been surgically sterilized at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than six (6) months prior to first dosing.
    8.Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three (3) months following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
    9.Subjects must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
    10.Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1.Attempted to quit smoking in the three (3) months prior to week 0.
    2.Use of smoking cessation aid, i.e. nicotine replacement therapy (NRT), bupropion, clonidine, nortryptiline or varenicline in the previous 3 months. Use of any other nicotine vaccine prior to the study. Use of NRT products during the study which are available OTC must be discouraged. Subjects using NRT can stay in the study. Use of NRT will be specifically checked by the investigator and documented on the NRT eCRF page.
    3.Use of any other vaccine based on the Qbeta virus like particle.
    4.Any surgical or medical condition which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
    •History of autoimmune or immunological disorders, immune deficiency. ANA at screening with a titer in the abnormal range for the lab (generally > 1:40).
    •History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
    •Significant cardiovascular disease including but not limited to angina pectoris, congestive heart failure, uncontrolled arterial hypertension, clinically significant heart murmurs, clinical significant arrhythmia or previous angioplasty or coronary artery bypass surgery
    •Significant hepatic disease.
    •Significant renal disease, i.e. history or laboratory findings indicating renal impairment.
    •Significant hematological disorder.
    •Significant pulmonary disease.
    •History of malignancy (excluding non-melanoma skin cancer and cured cervical cancer).
    •Organic neurological disorder or significant psychiatric disorder, especially presence of symptoms of depression or history of clinically significant depressive episodes during the last 10 years, and only if medical treatment for more than one month was required.
    •Women who are of child bearing potential, pregnant or breast feeding.
    •Individuals with high occupational aluminium exposure for example during aluminium manufacturing.
    •Donation or loss of 400 ml or more of blood within four (4) weeks prior to initial dosing, or longer if required by local regulation.
    •Significant acute illness or surgery within two (2) weeks prior to initial dosing.
    5.Concomitant medications for acute conditions at the time of screening are excluded – the inclusion of a subject into the study must be deferred until the condition is resolved and the acute medication terminated. Use of any concomitant medication which contains aluminium for example antacids, some aspirin preparations are not permitted. Any other medication that has been received in a stable manner will be allowed and must be documented in the CRF (e.g. anti-hypertensives and cholesterol lowering medication).
    6.Use of psychoactive drug (excluding sleeping pills) within one month before enrolment
    7.Any planned surgical intervention during the study period (excluding surgical intervention for minor procedures and only if ambulatory).
    8.Participation in any clinical investigation within eight (8) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    9.History of a positive HIV (ELISA and Western blot) Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
    10.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
    E.5 End points
    E.5.1Primary end point(s)
    4-week rate of continuous abstinence between weeks 8 and 12
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    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
    Last visit of last subject in study
    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 months4
    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 months4
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    None
    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 Decision2008-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-29
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