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NCT02987257 · ClinicalTrials.gov registry record · Phase 3
NATIENS: Optimal Management and Mechanisms of SJS/TEN
A Phase 3 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT02987257: Completed Phase 3 study, sponsored by Vanderbilt University Medical Center.
NCT02987257 is a Phase 3 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02987257, a Phase 3 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study Summary
The North American Therapeutics in Epidermal Necrolysis Syndrome (NATIENS) study is a multicenter double-blind randomized controlled assessment of two arms - one of systemic immunomodulatory therapy (etanercept) and one of supportive care deemed to be the current standard of care. We will leverage the opportunity of this controlled design to collect multiples samples with an aim to discover new genetic and biological markers for prevention and early diagnosis and define cellular and molecular mechanisms to facilitate discovery of promising treatment strategies. This study has been preceded by a planning phase to ensure testing and development of harmonized supportive care infrastructure and operating procedures across sites.
Primary Outcome
Patients will be assessed by two independent raters (burn surgeons, dermatologists, wound care experts) to determine the day of full re-epithelialization. For disagreements on the day of re-epithelialization the case with supporting photographs will be referred to an independent adjudication committee comprised of a minimum of three experts (a burn surgeon, dermatologist, wound care expert). In the instance of death will be the maximum period of re-epithelialization (21 days + 1)
Interventions
- DRUG Harmonized supportive care
- DRUG Etanercept 50 mg sc day 1 and day 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2023-03-21 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 3 |
What the finished NCT02987257 record still lists
NCT02987257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Harmonized supportive care is the first listed.
NCT02987257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02987257 about?
NCT02987257 is a clinical study titled "NATIENS: Optimal Management and Mechanisms of SJS/TEN". The North American Therapeutics in Epidermal Necrolysis Syndrome (NATIENS) study is a multicenter double-blind randomized controlled assessment of two arms - one of systemic immunomodulatory therapy (etanercept) and one of supportive care deemed to be the current standard of care. We will leverage t...
What is the current status of trial NCT02987257?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2023-03-21. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT02987257?
The interventions under investigation include: Harmonized supportive care (DRUG), Etanercept 50 mg sc day 1 and day 4 (DRUG).
Who is sponsoring clinical trial NCT02987257?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02987257's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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