Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
NCT ID: NCT06119490
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2023-07-05
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arocitinib-arm
Evaluation of the efficacy and safety of methylprednisolone combined with abrocitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with Arocitinib 200 mg daily.
Abrocitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
Tofacitinib-arm
Evaluation of the efficacy and safety of methylprednisolone combined with tofacitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with tofacitinib 10 mg daily.
Tofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Interventions
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Abrocitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
Tofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
3. Liver and kidney function is within acceptable ranges.
4. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
5. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
6. Patients need to be capable of participating in follow-up visits and treatment plans.
Exclusion Criteria
2. Pregnant or breastfeeding women.
3. Severe infectious conditions.
4. History of central nervous system demyelinating diseases.
5. History of lymphoproliferative diseases.
6. Active and latent tuberculosis.
7. HIV carriers with a CD4+ T cell count lower than (\<200/mL).
8. Active HBV/HCV infection.
9. Coagulation disorders or a tendency for thrombosis.
10. Significant abnormalities in blood routine indicators.
11. Liver or kidney dysfunction.
18 Years
70 Years
ALL
No
Sponsors
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Peng Zhang
OTHER
Responsible Party
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Peng Zhang
Investigator
Locations
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Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IECFOM-2023-400
Identifier Type: -
Identifier Source: org_study_id