NCT04571216

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: NFL Biosciences SAS · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Smoking Cessation
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	NFL-101 dose 1	Subcutaneous injections
DRUG	NFL-101 dose 2	Subcutaneous injections
DRUG	Placebo	Subcutaneous injections

Timeline

• Start date: 2021-04-12
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2020-09-30
• Last updated: 2025-06-19

Locations

9 sites across 1 country: France