drugset / Trial / NCT04435665

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

NCT04435665 ↗

Phase 2 Completed 48 enrolled NFlection Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-08-21
Primary completion
2021-04-08
Completion
2021-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject NEDOMETINIB Small molecule — Topical