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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04571216
Registration number
NCT04571216
Ethics application status
Date submitted
15/09/2020
Date registered
30/09/2020
Date last updated
19/06/2025
Titles & IDs
Public title
Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
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Scientific title
Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
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Secondary ID [1]
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V10.1
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Universal Trial Number (UTN)
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Trial acronym
CESTO2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
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Nicotine Dependence
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Condition category
Condition code
Mental Health
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Addiction
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of participants achieving 4-week continuous abstinence
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Assessment method [1]
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4-weekcontinuous abstinence measured from D15 to D43
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Timepoint [1]
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4-week
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Primary outcome [2]
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Rate of participants achieving 6-month continuous abstinence
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Assessment method [2]
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6-month continuous abstinence measured from D15 to M6
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Timepoint [2]
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6-month
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Secondary outcome [1]
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Rate of participants achieving 12-month continuous abstinence
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Assessment method [1]
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12-month continuous abstinence measured from D15 to M12
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Timepoint [1]
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12-month
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Secondary outcome [2]
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Rate of participants achieving 3-month continuous abstinence
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Assessment method [2]
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3-month continuous abstinence measured from D15 to M3
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Timepoint [2]
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3-month
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Secondary outcome [3]
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Rate of participants achieving 3-month continuous abstinence End of Treatment
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Assessment method [3]
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continuous abstinence measured during 3-month after end of treatment
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Timepoint [3]
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3-month
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Secondary outcome [4]
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Rate of participants achieving 6-month continuous abstinence End of Treatment
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Assessment method [4]
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continuous abstinence measured during 6-month after end of treatment
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Timepoint [4]
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6-month
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Secondary outcome [5]
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Rate of participants achieving 3-month continuous abstinence End of Study
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Assessment method [5]
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continuous abstinence measured from M9 to M12
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Timepoint [5]
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3-month
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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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/04/2024
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Sample size
Target
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Accrual to date
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Final
318
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Clermont-Ferrand
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Country [2]
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France
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State/province [2]
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Dijon
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Country [3]
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France
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State/province [3]
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Gières
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Country [4]
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France
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State/province [4]
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Lorient
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Country [5]
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France
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State/province [5]
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Marseille
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Country [6]
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France
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State/province [6]
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Montpellier
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Country [7]
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France
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State/province [7]
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Pessac
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Country [8]
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France
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State/province [8]
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Poitiers
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Country [9]
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France
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State/province [9]
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Rennes
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
NFL Biosciences SAS
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04571216
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Trial related presentations / publications
Lafay-Chebassier C, Girodet PO, Laine F, Allain JS, Pickering G, Latreille M, Demina A, Chevassus H, Ingrand I, Tartour E, Benhamouda N, Fraisse ML, Chamitava L, Pletan Y, Balland J, Donazzolo Y, Lafont B. Efficacy and Safety of NFL-101 as a Smoking Cessation Therapy: A Randomized Phase II Clinical Trial CESTO2. Nicotine Tob Res. 2025 Aug 30:ntaf181. doi: 10.1093/ntr/ntaf181. Online ahead of print.
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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
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Contacts
Principal investigator
Name
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Yves Donazzolo, MD
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Address
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Optimed Eurofins
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Bruno Lafont, MS
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Address
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Country
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Phone
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+33603063266
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04571216
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