NATIENS: A Phase III Randomized Double-Blinded Placebo Controlled Study to Determine the Optimal Management and Mechanisms of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
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.
• Age \>18 years
• Subject and/or legally authorized representative must be able to understand and provide informed consent.
• Erythematous to dusky macules that show evidence of coalescing and/or denuding skin or blistering in a predominantly truncal distribution (Nikolsky sign = sloughing with direct lateral pressure on non-blistered but involved skin should be considered as a supportive feature
• At least two of the following:
‣ Mucous membrane involvement
⁃ Prodromal symptoms including fever, myalgia, and headache
⁃ Evidence of disease progression with an increasing number of skin lesions
• History of a newly used medication within the last 2 months that has not been tolerated for longer than 12 weeks in the past
• Females of childbearing potential must have a negative pregnancy test prior to randomization.