NCT04435665

NFX-179 Topical Gel Treatment in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Phase 2a Study to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of NFX-179 Gel in Subjects With Cutaneous Neurofibromas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: NFlection Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll and treat subjects with cutaneous neurofibromas with NFX-179, a topical study drug. Eligible subjects will receive treatment for 28 days and be observed by a study doctor for approximately 56 days. Subjects will be randomly assigned to 1 of 4 treatment groups. 3 of the treatment groups will receive a specific dose NFX-179, and 1 group will receive placebo. The subject, study doctor, and NFlection Therapeutics will not know what treatment group each subject is assigned. Study participation requires at least 7 clinic visits, blood, urine, and tissue collection, images of the treated cutaneous neurofibromas, electrocardiograms, and information regarding the subject's medical and disease history.

Conditions

• Neurofibromatosis 1
• Cutaneous Neurofibroma

Interventions

Type	Name	Description
DRUG	NFX-179 Gel	gel for topical administration
DRUG	Vehicle Gel	vehicle gel for topical administration

Timeline

• Start date: 2020-08-21
• Primary completion: 2021-04-08
• Completion: 2021-04-14
• First posted: 2020-06-17
• Last updated: 2022-08-09
• Results posted: 2022-08-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study