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Small study tests drug for rare, Life-Threatening skin condition

NCT ID NCT02987257

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2 people

The number who actually took part.

Started

Mar 2023

Finished

Oct 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Drug-Related Side Effects and Adverse Reactions Stevens-Johnson syndrome toxic epidermal necrolysis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory University at Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • University of California, Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Florida Health Burn Center

    Gainesville, Florida, 32610, United States

  • University of Miami, Ryder Trauma Center

    Miami, Florida, 33136, United States

  • University of Tennessee Health Sciences Center

    Memphis, Tennessee, 38103, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Washington, Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008, United States

  • Vanderblt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.