drugset / Trial / NCT04571216

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

NCT04571216 ↗

Phase 2 Completed 318 enrolled NFL Biosciences SAS
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-04-12
Primary completion
2024-04-12
Completion
2024-04-12

Outcome

Met primary endpoint

release “CESTO II trial has thus demonstrated that, even with a limited number of patients, NFL-101 is able to meet the efficacy criteria” nflbiosciences.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject NFL-101 Protein / enzyme biologic 50 ug Subcutaneous
Subject NFL-101 Protein / enzyme biologic 100 ug Subcutaneous

Indications