drugset / Trial / NCT04571216
Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NFL-101 | Protein / enzyme biologic | 50 ug | Subcutaneous |
| Subject | NFL-101 | Protein / enzyme biologic | 100 ug | Subcutaneous |