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NFX-179 Gel Low for Neurofibroma

Phase 2
Waitlist Available
Research Sponsored by NFlection Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 8
Awards & highlights

Study Summary

This trial 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.

Eligible Conditions
  • Neurofibroma
  • Neurofibromatosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Adverse Events
Phospho-erk (p-ERK) Levels of Target cNF Tumors in NFX-179 Gel Group and Vehicle Gel Group After 28 Days of Once-daily (QD) Application
Safety and Tolerability of NFX-179 Gel Measured by Local Tolerability Assessment
Secondary outcome measures
Change in Physician Assessment of Tumor Severity Score
Change in Subject Self-Assessment of Tumor Severity Score
Percent Change in cNF Tumor Volume (Cubic Millimeters)
+1 more

Side effects data

From 2021 Phase 2 trial • 48 Patients • NCT04435665
8%
Anxiety
8%
Basal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Arm (Placebo)
NFX-179 Gel Low (0.05%)
NFX-179 Gel Mid (0.15%)
NFX-179 Gel High (0.50%)

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NFX-179 Gel MidExperimental Treatment1 Intervention
NFX-179 Gel for topical administration, once daily for 28 days
Group II: NFX-179 Gel LowExperimental Treatment1 Intervention
NFX-179 Gel for topical administration, once daily for 28 days
Group III: NFX-179 Gel HighExperimental Treatment1 Intervention
NFX-179 Gel for topical administration, once daily for 28 days
Group IV: Vehicle ArmPlacebo Group1 Intervention
Vehicle Gel, for topical administration, once daily for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NFX-179 Gel
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

NFlection Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
199 Total Patients Enrolled
1 Trials studying Neurofibroma
199 Patients Enrolled for Neurofibroma
Guy Webster, MD, PhDStudy DirectorNFlection Therapeutics
~10 spots leftby Jun 2025
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