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Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy (CESTO2)

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ClinicalTrials.gov Identifier: NCT04571216
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Yves Donazzolo, NFL Biosciences SAS

Study Description
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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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Nicotine Dependence Drug: NFL-101 dose 1 Drug: NFL-101 dose 2 Drug: Placebo Phase 2

Detailed Description:
Long-term smoking cessation or reduction had been observed in thousands of patients when 1 or 2 subcutaneous injections of a desensitization treatment against tobacco allergy were taking place concomitantly with Target Quit Date (TQD). NFL Biosciences SAS developed a tobacco cessation drug candidate (NFL-101) consisting of a nicotine-free extract of tobacco proteins. According to the observations made during CESTO, a Phase I study on 24 smokers, NFL-101 appears to work by reducing cigarette appetence immediately and over a week after each injection.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
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
 Drug: NFL-101 dose 1
Subcutaneous injections
Other Name: Tobacco leaf extract
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
 Drug: NFL-101 dose 2
Subcutaneous injections
Other Name: Tobacco leaf extract
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
 Drug: Placebo
Subcutaneous injections
Other Name: WFI


Outcome Measures
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Primary Outcome Measures :
  1. Rate of participants achieving 4-week continuous abstinence [ Time Frame: 4-week ]
    4-weekcontinuous abstinence measured from D15 to D43

  2. Rate of participants achieving 6-month continuous abstinence [ Time Frame: 6-month ]
    6-month continuous abstinence measured from D15 to M6


Secondary Outcome Measures :
  1. Rate of participants achieving 12-month continuous abstinence [ Time Frame: 12-month ]
    12-month continuous abstinence measured from D15 to M12

  2. Rate of participants achieving 3-month continuous abstinence [ Time Frame: 3-month ]
    3-month continuous abstinence measured from D15 to M3

  3. Rate of participants achieving 3-month continuous abstinence End of Treatment [ Time Frame: 3-month ]
    continuous abstinence measured during 3-month after end of treatment

  4. Rate of participants achieving 6-month continuous abstinence End of Treatment [ Time Frame: 6-month ]
    continuous abstinence measured during 6-month after end of treatment

  5. Rate of participants achieving 3-month continuous abstinence End of Study [ Time Frame: 3-month ]
    continuous abstinence measured from M9 to M12


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ≥ 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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571216


Contacts
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Contact: Bruno Lafont, MS +33603063266 blafont@nflbiosciences.com

Locations
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France
Centre d'Investigation Clinique de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Gisèle Pickering, MD         
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Benoit Trojak, MD         
Eurofins Optimed Recruiting
Gières, France, 38610
Contact: Félix Collet, MSc    +33(0) 4 38 37 27 48    felixcollet@eurofins.com   
Groupe Hospitalier Bretagne Sud Not yet recruiting
Lorient, France, 56322
Contact: Jean Sebastien Allain, MD         
Centre d'Investigation Clinique de Marseille Nord Recruiting
Marseille, France, 13015
Contact: Bertrand Dussol, MD         
Centre d'Investigation Clinique de Montpellier Recruiting
Montpellier, France, 34295
Contact: Florence Galtier, MD         
Centre d'Investigation Clinique de Bordeaux Recruiting
Pessac, France, 33604
Contact: Pierre -Olivier Girodet, MD         
Centre d'Investigation Clinique de Poitiers (CIC 1402) Recruiting
Poitiers, France, 86021
Contact: Claire Lafay-Chebassier, PharmD         
Centre d'Investigation Clinique de Rennes Recruiting
Rennes, France, 35000
Contact: Fabrice Laine, MD         
Sponsors and Collaborators
NFL Biosciences SAS
Investigators
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Principal Investigator: Yves Donazzolo, MD Optimed Eurofins
More Information
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Responsible Party: Yves Donazzolo, Principal Investigator, NFL Biosciences SAS
ClinicalTrials.gov Identifier: NCT04571216    
Other Study ID Numbers: V10.1
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders