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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04571216




Registration number
NCT04571216
Ethics application status
Date submitted
15/09/2020
Date registered
30/09/2020
Date last updated
24/10/2023

Titles & IDs
Public title
Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
Scientific title
Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
Secondary ID [1] 0 0
V10.1
Universal Trial Number (UTN)
Trial acronym
CESTO2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Nicotine Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NFL-101 dose 1
Treatment: Drugs - NFL-101 dose 2
Treatment: Drugs - Placebo

Experimental: NFL-101 Dose 1 - 50 µg per injection (in each arm), two injections at day 1, two injections at day 8, optional injections later on

Experimental: NFL-101 Dose 2 - 100 µg per injection (in each arm), two injections at day 1, two injections at day 8, optional injections later on

Placebo Comparator: Placebo - The placebo will consist of two syringes containing 1 mL of dilution solution, two injections at day 1, two injections at day 8, optional injections later on


Treatment: Drugs: NFL-101 dose 1
Subcutaneous injections

Treatment: Drugs: NFL-101 dose 2
Subcutaneous injections

Treatment: Drugs: Placebo
Subcutaneous injections
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of participants achieving 4-week continuous abstinence
Timepoint [1] 0 0
4-week
Primary outcome [2] 0 0
Rate of participants achieving 6-month continuous abstinence
Timepoint [2] 0 0
6-month
Secondary outcome [1] 0 0
Rate of participants achieving 12-month continuous abstinence
Timepoint [1] 0 0
12-month
Secondary outcome [2] 0 0
Rate of participants achieving 3-month continuous abstinence
Timepoint [2] 0 0
3-month
Secondary outcome [3] 0 0
Rate of participants achieving 3-month continuous abstinence End of Treatment
Timepoint [3] 0 0
3-month
Secondary outcome [4] 0 0
Rate of participants achieving 6-month continuous abstinence End of Treatment
Timepoint [4] 0 0
6-month
Secondary outcome [5] 0 0
Rate of participants achieving 3-month continuous abstinence End of Study
Timepoint [5] 0 0
3-month

Eligibility
Key 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 =
3 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 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, vasectomised partner or
sexual abstinence for the duration of the trial; (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 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;

- Normal ECG recording on a 12-lead ECG at the screening visit:

- 120 < PR < 210 ms,

- QRS < 120 ms,

- QTcf = 430 ms for male and < 450 ms for female,

- No sign of any trouble of sinusal automatism,

- Or considered NCs by investigators;

- Negative prick test at screening visit for the whole study product (extract of Tobacco
leaf and NaCL), and positive for histamine;

- 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnancy and breastfeeding;

- Concomitant participation to another clinical trial;

- Concomitant active infectious diseases;

- Concomitant use of treatment known to interfere with immune response (not including
desensitization therapies);

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
318
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Clermont-Ferrand
Country [2] 0 0
France
State/province [2] 0 0
Dijon
Country [3] 0 0
France
State/province [3] 0 0
Gières
Country [4] 0 0
France
State/province [4] 0 0
Lorient
Country [5] 0 0
France
State/province [5] 0 0
Marseille
Country [6] 0 0
France
State/province [6] 0 0
Montpellier
Country [7] 0 0
France
State/province [7] 0 0
Pessac
Country [8] 0 0
France
State/province [8] 0 0
Poitiers
Country [9] 0 0
France
State/province [9] 0 0
Rennes

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
NFL Biosciences SAS
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind,
placebo-controlled Phase II clinical trial.

The main objectives are to select the most efficient dose and to assess long-term efficacy of
NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04571216
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Yves Donazzolo, MD
Address 0 0
Optimed Eurofins
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bruno Lafont, MS
Address 0 0
Country 0 0
Phone 0 0
+33603063266
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04571216