NATIENS: Optimal Management and Mechanisms of SJS/TEN

Completed · Phase 3 · Has a placebo group

Conditions studied: Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses

In brief

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.

Key facts

Study ID

NCT02987257

Run by

Vanderbilt University Medical Center

People needed

2

Starts

2023-03-21

Expected to finish

2025-10-31

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subject or legally authorized representative is not willing to provide informed consent.
• A serious drug reaction or possible alternative dermatologic diagnosis at the time of initial evaluation not in keeping with drug-induced SJS/TEN (e.g. graft versus host disease).
• If greater than 5 days has elapsed from onset of initial cutaneous or mucosal signs of the disease as obtained by patient history or documentation.
• Patients who have received etanercept in the last 6 months.
• Patients who in time since onset of SJS/TEN illness have received intravenous immune globulin (IVIg) or > 2 doses of pulsed corticosteroid (defined by > 250 mg prednisone equivalent) prior to enrollment in the study.
• End-stage liver disease (Child Pugh A, B or C or severe liver dysfunction).
• Grade 2 or higher liver dysfunction (alanine aminotransferase >3 fold or bilirubin >3 fold the upper limit of normal).
• Any organ transplant.
• Pre-existing Class III/IV Heart Failure (New York Heart Association Functional Classification).
• Multiple Sclerosis or other demyelinating diseases.
• Pregnancy or breastfeeding.
• Current or past history of immune checkpoint inhibitor therapy for cancer.
• Absolute need for a drug that interacts with cyclosporine without an appropriate substitution.
• History of other immunosuppressive or immunomodulatory therapy that could significant impact treatment or interpretation of response to treatment (i.e. azathioprine, methotrexate, mycophenolate mofetil, mycophenolate sodium, rituximab, JAK inhibitors, IL-17 inhibitors, IL-23 inhibitors, other TNF alpha antagonists (see MOP).
• Use of surgical debridement and/or xenograft.
• Known positive SARS-CoV-2 on RT-PCR within 10 days prior to screening or within 5 days of admission or symptomatic COVID-19 infection at screening. Symptomatic patients with a positive SARS-CoV-2 on RT-PCR or comparable assay beyond 10 days must be evaluated by the Independent Protocol Monitor.
• Clinical or radiographic evidence of active tuberculosis or endemic mycoses.
• History or evidence of any other clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study such as known sepsis/systemic infection requiring antibiotic therapy.
• Known hypersensitivity to Enbrel® (etanercept).
• Receipt of a live attenuated vaccine within 30 days of enrollment.

Where it is running

• Valleywise Health Medical Center — Phoenix, Arizona, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida Health Burn Center — Gainesville, Florida, United States
• University of Miami, Ryder Trauma Center — Miami, Florida, United States
• Emory University at Grady Memorial Hospital — Atlanta, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Wayne State University — Detroit, Michigan, United States
• University of Tennessee Health Sciences Center — Memphis, Tennessee, United States
• Vanderblt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Washington, Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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