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    Summary
    EudraCT Number:2017-002897-38
    Sponsor's Protocol Code Number:CESTOII
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002897-38
    A.3Full title of the trial
    Phase II Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
    A.4.1Sponsor's protocol code numberCESTOII
    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 SponsorNFL BIOSCIENCES SAS
    B.1.3.4CountryFrance
    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 supportNFL BIOSCIENCES SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEUROFINS OPTIMED
    B.5.2Functional name of contact pointDominique GARIN
    B.5.3 Address:
    B.5.3.1Street Address1 rue des Essarts
    B.5.3.2Town/ cityGières
    B.5.3.3Post code38610
    B.5.3.4CountryFrance
    B.5.4Telephone number+330438 37 27 40
    B.5.5Fax number+330438 37 27 41
    B.5.6E-maildominiquegarin@eurofins.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.3.2Product code NFL-101
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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
    Tobacco addiction
    E.1.1.1Medical condition in easily understood language
    Tobacco addiction
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10043905
    E.1.2Term Tobacco use
    E.1.2System Organ Class 100000004869
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess efficacy of NFL-101 in helping smoking subjects to reduce their consumption during a quit attempt period compared to a placebo.
    E.2.2Secondary objectives of the trial
    - To assess efficacy in improving smoking cessation, smoking reduction, quit attempts; to assess effect, safety and immunogenicity of NFL-101 in smoking subjects compared to a placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subject ≥ 18 and ≤ 70-year-old;
    - With ECOG/WHO performance status 0-1 (Appendix 1);
    - Subject currently smoking at least 11 cigarettes per day and with a dependency level ≥ 5 according to Fagerström Test for Nicotine Dependence scoring (see Appendix 2) [1];
    - Subject willing to quit smoking;
    - Good general health (i.e. no uncontrolled medical condition, or no medical condition that could interfere with the conduct and the outcomes of the study, according to the investigator);
    - Good mental health (i.e. no alcohol or drug abuse in the past year, no psychiatric history– adequately treated depression is accepted);
    - For women of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for at least 28 days after the second injection;
    (Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months)) ;
    - Negative pregnancy test at screening baseline;
    - Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator;
    - Normal ECG recording on a 12-lead ECG at the screening visit:
    o 120 < or equal PR < 210 ms,
    o QRS < 120 ms,
    o QTcf < or equal 430 ms for male and < or equal 450 ms for female,
    o No sign of any trouble of sinusal automatism,
    o Or considered NCs by investigators;
    - French speaking subject;
    - Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
    - Subject having signed the informed consent agreement.
    E.4Principal exclusion criteria
    - Pregnancy and breastfeeding;
    - Concomitant participation to another clinical trial;
    - Concomitant active infectious diseases;
    - Concomitant desensitization therapy;
    - History of asthma or immune disorders;
    - History of any allergy including to nicotine or any components of study product;
    - Uncontrolled diabetes;
    - Prior exposure to a nicotine vaccine or to any other vaccine within 30 days before study product administration;
    - Concomitant use (and within previous 60 days) of any smoking cessation therapy (including electronic cigarettes and alternative methods such as hypnosis or acupuncture);
    - Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the informed consent or to terminate the study.
    - Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study
    - Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy in helping smoking subjects to reduce their consumption during a quit attempt period will be assessed by the rate of subjects who will achieve at least a 50% continuous reduction in smoking between the day of screening and a 4 week period from the day of the 2nd injection (from D11 to D39).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening. From D11 to D39
    E.5.2Secondary end point(s)
    The efficacy in improving smoking cessation and reduction will be assessed by:
    - Rate of subjects who will achieve continuous abstinence from D11 to D95, from D25 to D95, from D39 to D95;
    - Rate of subjects who will achieve 7-day point prevalence abstinence at stated time points, i.e. abstinence during the 7 days prior to D11, D25, D39 and D95;
    - Rate of subjects who will achieve x-day point prevalence abstinence (x been equal to 7, 6, 5, 4, 3, 2, or 1), i.e. abstinence during x consecutive days, between D1 and D11, between D1 and D25, between D1 and D39, between D1 and D95;
    - Rate of subjects who will achieve a 50% continuous reduction in smoking between the day of screening and D11, D25, D39 and D95;
    - Rate of subjects who will achieve a 50% continuous reduction in smoking between the day of screening and D11 to D25, between the day of screening and D11 to D95 between the day of screening and D25 to D39, between the day of screening and D25 to D95, between the day of screening and D39 to D95;
    - Reduction in smoking at D11, D25, D39 and D95;
    - Cigarette consumption at D11, D25, D39 and D95;
    - Number of days without smoking from D1 to D11, from D1 to D25;
    - Evolution in motivation to stop smoking at each visit assessed by the single-item Motivation To Stop Scale (MTSS).
    The perceived effect of the treatment will be assessed by MNWS and FTCQ-12 questionnaires at each visit.
    The safety of NFL-101 will be assessed via the description of adverse events (AEs).
    Immunogenicity will be assessed by measures of anti-NFL-101 IgG, the relationship between antibody-titre levels and clinical efficacy will be explored.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, from D11 to D95.
    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 No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state100
    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 Decision2017-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-12
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