Small study tests drug for rare, Life-Threatening skin condition
NCT ID NCT02987257
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a drug called etanercept against a placebo for people with severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). Only 2 adults took part. The goal was to see if the drug speeds up skin healing and to learn more about the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- etanercept
- What this could lead to
- If it works, this could point toward a better treatment for severe skin reactions like Stevens-Johnson syndrome.
- What could go wrong
- This trial was very small (only 2 participants) and completed, so results may not apply widely. Etanercept can increase infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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2 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>18 years 2. Subject and/or legally authorized representative must be able to understand and provide informed consent. 3. 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 4. At least two of the following: 1. Mucous membrane involvement 2. Prodromal symptoms including fever, myalgia, and headache 3. Evidence of disease progression with an increasing number of skin lesions 5. History of a newly used medication within the last 2 months that has not been tolerated for longer than 12 weeks in the past 6. Females of childbearing potential must have a negative pregnancy test prior to randomization. Exclusion Criteria: 1. Subject or legally authorized representative is not willing to provide informed consent. 2. 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). 3. 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. 4. Patients who have received etanercept in the last 6 months. 5. 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. 6. End-stage liver disease (Child Pugh A, B or C or severe liver dysfunction). 7. Grade 2 or higher liver dysfunction (alanine aminotransferase \>3 fold or bilirubin \>3 fold the upper limit of normal). 8. Any organ transplant. 9. Pre-existing Class III/IV Heart Failure (New York Heart Association Functional Classification). 10. Multiple Sclerosis or other demyelinating diseases. 11. Pregnancy or breastfeeding. 12. Current or past history of immune checkpoint inhibitor therapy for cancer. 13. Absolute need for a drug that interacts with cyclosporine without an appropriate substitution. 14. 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). 15. Use of surgical debridement and/or xenograft. 16. 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. 17. Clinical or radiographic evidence of active tuberculosis or endemic mycoses. 18. 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. 19. Known hypersensitivity to Enbrel® (etanercept). 20. Receipt of a live attenuated vaccine within 30 days of enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University at Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Loyola University Medical Center
Maywood, Illinois, 60153, United States
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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University of California, Davis Medical Center
Sacramento, California, 95817, United States
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University of Florida Health Burn Center
Gainesville, Florida, 32610, United States
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University of Miami, Ryder Trauma Center
Miami, Florida, 33136, United States
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University of Tennessee Health Sciences Center
Memphis, Tennessee, 38103, United States
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University of Texas Medical Branch
Galveston, Texas, 77555, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Washington, Harborview Medical Center
Seattle, Washington, 98104, United States
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Valleywise Health Medical Center
Phoenix, Arizona, 85008, United States
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Vanderblt University Medical Center
Nashville, Tennessee, 37232, United States
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Wayne State University
Detroit, Michigan, 48201, United States
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