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NCT04435665 · ClinicalTrials.gov registry record · Phase 2
NFX-179 Topical Gel Treatment in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
A Phase 2 study, sponsored by NFlection Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT04435665: Completed Phase 2 study, sponsored by NFlection Therapeutics.
NCT04435665 is a Phase 2 study that has completed, run by NFlection Therapeutics. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04435665, a Phase 2 study, has completed, sponsored by NFlection Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
Pharmacodynamic activity (biochemical and physiologic effects of drugs) of NFX-179 Gel as defined by suppression of phospho-ERK (p-ERK) levels in Target cNF Tumors in each NFX-179 Gel group compared with the Vehicle Gel group after 28 days of once-daily (QD) application will be measured at Week 4
Interventions
- DRUG Vehicle Gel
- DRUG NFX-179 Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2021-04-14 |
| Phase | Phase 2 |
What the finished NCT04435665 record still lists
NCT04435665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Gel is the first listed.
NCT04435665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04435665 about?
NCT04435665 is a clinical study titled "NFX-179 Topical Gel Treatment in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)". 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 treatme...
What is the current status of trial NCT04435665?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-08-21. Estimated completion is 2021-04-14.
What interventions are being tested in trial NCT04435665?
The interventions under investigation include: Vehicle Gel (DRUG), NFX-179 Gel (DRUG).
Who is sponsoring clinical trial NCT04435665?
This trial is sponsored by NFlection Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04435665's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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