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Immunosuppressant
Etanercept vs Cyclosporine for Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (NATIENS Trial)
Phase 3
Recruiting
Led By Elizabeth J Phillips, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of disease progression with an increasing number of skin lesions
Mucous membrane involvement
Must not have
Known hypersensitivity to Sandimmune® (cyclosporine) and/or Cremophor® EL (polyoxyethylated castor oil).
Receipt of a live attenuated vaccine within 30 days of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Pivotal Trial
Summary
This trial is testing whether two therapeutic interventions (etanercept vs cyclosporine) are better than supportive care alone for treating Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Who is the study for?
Adults over 18 with Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, showing skin and mucous membrane symptoms, fever, muscle pain, headache, and a recent history of medication intolerance. Pregnant or breastfeeding women and those with certain medical conditions or treatments are excluded.
What is being tested?
The NATIENS study is testing whether cyclosporine (for 14 days) or etanercept (two doses) alongside standard care improves recovery from SJS/TEN compared to standard care alone. It's a phase III trial involving multiple U.S. centers where patients are randomly assigned to one of the three groups in a blinded manner.
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk, possible liver and kidney issues due to cyclosporine, injection site reactions from etanercept, allergic reactions if sensitive to either drug's components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin cancer is getting worse with more lesions.
Select...
My condition affects the moist tissues of my body.
Select...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to Sandimmune or Cremophor EL.
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I have not received a live vaccine in the last 30 days.
Select...
I have taken etanercept or cyclosporine in the past 6 months.
Select...
I am on dialysis.
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I have had an organ transplant.
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I have Multiple Sclerosis or a similar condition.
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I haven't taken strong immune system affecting drugs that could interfere with the treatment.
Select...
I have had surgery to remove damaged tissue or used a graft from another species.
Select...
I do not have active tuberculosis or fungal infections.
Select...
I have chronic kidney disease with an eGFR less than 30.
Select...
I must take a medication that interacts with cyclosporine and cannot be replaced.
Select...
I have severe heart failure.
Select...
I have received immune therapy for my cancer.
Select...
I have received IV immune treatment or more than 2 high-dose steroid treatments for my SJS/TEN.
Select...
My liver is severely damaged.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to complete re-epithelialization
Secondary study objectives
Hospital length of stay
Infections
Mortality
+3 moreOther study objectives
Granulysin, IL-15 and other cytokine measurements
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Etanercept 50mg sc day 1 and day 4Active Control2 Interventions
Harmonized supportive care with placebo days 1 and 4
Group II: Harmonized supportive carePlacebo Group1 Intervention
Harmonized supportive care with etanercept placebo days 1 and 4
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,351 Total Patients Enrolled
University of OttawaOTHER
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269,499 Total Patients Enrolled
University of TorontoOTHER
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1,042,402 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion means that the participant needs to meet at least two of the following conditions.You have a severe reaction to a drug, or a skin condition that is not related to a drug reaction.If more than 5 days have passed since you first noticed skin or mouth problems.I am allergic to Sandimmune or Cremophor EL.You are allergic to Enbrel® (etanercept).I have not received a live vaccine in the last 30 days.I have had symptoms like fever, muscle pain, and headaches recently.My skin cancer is getting worse with more lesions.I have taken etanercept or cyclosporine in the past 6 months.I am on dialysis.I haven't taken strong immune system affecting drugs that could interfere with the treatment.I have had surgery to remove damaged tissue or used a graft from another species.I do not have active tuberculosis or fungal infections.I have red to dark spots on my trunk that may be merging or causing skin peeling.You have tested positive for COVID-19 within the last 10 days, or within 5 days of admission, or have symptoms of COVID-19 at the time of screening. If you have symptoms and a positive test beyond 10 days, a special monitor will check your situation.I have had an organ transplant.I have Multiple Sclerosis or a similar condition.I recently started a new medication that I couldn't tolerate for more than 12 weeks.I have chronic kidney disease with an eGFR less than 30.I must take a medication that interacts with cyclosporine and cannot be replaced.I have severe heart failure.I am of childbearing age and have a negative pregnancy test.I have received immune therapy for my cancer.My condition affects the moist tissues of my body.I have received IV immune treatment or more than 2 high-dose steroid treatments for my SJS/TEN.You have moderate to severe liver problems, as indicated by specific blood test results.I am older than 18 years.My liver is severely damaged.
Research Study Groups:
This trial has the following groups:- Group 1: Etanercept 50mg sc day 1 and day 4
- Group 2: Harmonized supportive care
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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