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    Summary
    EudraCT Number:2022-002492-11
    Sponsor's Protocol Code Number:PRECESTO
    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:2022-07-11
    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 number2022-002492-11
    A.3Full title of the trial
    Phase II Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes
    Étude de phase II pour évaluer l'efficacité et la sécurité de NFL-101 sur la réduction des propriétés de renforcement des cigarettes
    A.4.1Sponsor's protocol code numberPRECESTO
    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 SA
    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 SA
    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 pointFélix Collet
    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-mailaecoptimed@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 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 23.0
    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 reducing the positive reinforcing properties of cigarettes compared to placebo measured by the mCEQ "Smoking Satisfaction" (items 1, 2, and 12) subscale.
    E.2.2Secondary objectives of the trial
    To assess efficacy of NFL-101 in reducing the reinforcing properties of cigarettes compared to a placebo and safety after one administration of NFL-101.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • • Male or female subject ≥ 18 and ≤ 70-year-old at the time of consent;
    • Internet connection;
    • Subject currently smoking at least 10 cigarettes per day;
    • Exhaled CO ≥ 9 ppm;
    • Subject with a mCEQ Satisfaction subscale score ≥ 4
    • Subject not wanting to stop smoking (MTSS score ≤ 2)
    • Subject not under tobacco cessation therapy since at least 30 days;
    • Considered as healthy for the study after a comprehensive clinical assessment (detailed medical history and complete physical examination);
    • For women of childbearing potential: commitment to consistently and correctly use of a highly effective contraceptive measure: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence for the duration of the trial;
    • Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months);
    • Negative pregnancy test at screening visit;
    • 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;
    • Negative prick test at screening visit for the whole study product (extract of Tobacco leaf and NaCL), and positive for histamine;
    • 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;
    • 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 (for subjects in France only);
    • 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 primary endpoint is the mCEQ "Smoking Satisfaction" subscale measured at D4.
    E.5.2Secondary end point(s)
    • mCEQ "Smoking Satisfaction" (items 1, 2, and 12) subscale measured at D7, D14, D21 and D28
    • mCEQ "Psychological Reward" (items 4 through 8); "Aversion" (items 9 and 10); "Enjoyment of Respiratory Tract Sensations" (item 3); and "Craving Reduction“ (item 11) subcales, measured at D4, D7, D14, D21 and D28
    • Question “Have you found your urges to smoke stronger or weaker than usual in the last 24 hours?” (with response options of “much stronger,” “slightly stronger,” “same as before,” “slightly weaker,” and “much weaker”) at D4, D7, D14, D21 and D28
    • Question “Have you found cigarettes more or less enjoyable than usual in the last 24 hours?” (with response options of “much more enjoyable,” “slightly more enjoyable,” “same as before,” “slightly less enjoyable,” and “much less enjoyable”) at D4, D7, D14, D21 and D28
    • Change in MTSS from screening to D28
    • Change in number of cigarettes smoked from screening to D28
    • Preference question at EOS visit: “Is there one of the two administrations that made you want to quit smoking or reduce your cigarette consumption more than the other?”
    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 No
    E.8.1.6Cross over Yes
    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.8.5.1Number of sites anticipated in the EEA1
    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 No
    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 months12
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state34
    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 Decision2022-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-10
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