Tobacco addiction MedDRA version: 20.0 Level: HLT Classification code 10043905 Term: Tobacco use System Organ Class: 100000004869
Conditions
Interventions
Product Code: NFL-101
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
NFL BIOSCIENCES SAS
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess efficacy of NFL-101 in helping smoking subjects to reduce their consumption during a quit attempt period compared to a placebo.;Secondary Objective: - 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.;Primary 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).;Timepoint(s) of evaluation of this end point: Screening. From D11 to D39 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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.;Timepoint(s) of evaluation of this end point: Screening, from D11 to D95. | — |
Countries
France
Contacts
Public ContactDominique GARIN
EUROFINS OPTIMED
Outcome results
None listed