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RecruitingEarly Phase 1NCT06119490

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study

Sponsor

Peng Zhang

Enrollment

30 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

Toxic Epidermal Necrolysis

Summary

To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • Age 18 and above.
  • Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
  • Liver and kidney function is within acceptable ranges.
  • Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
  • Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
  • Patients need to be capable of participating in follow-up visits and treatment plans.

Exclusion Criteria11

  • History of allergy to JAK inhibitors.
  • Pregnant or breastfeeding women.
  • Severe infectious conditions.
  • History of central nervous system demyelinating diseases.
  • History of lymphoproliferative diseases.
  • Active and latent tuberculosis.
  • HIV carriers with a CD4+ T cell count lower than (<200/mL).
  • Active HBV/HCV infection.
  • Coagulation disorders or a tendency for thrombosis.
  • Significant abnormalities in blood routine indicators.
  • Liver or kidney dysfunction.

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Interventions

DRUGAbrocitinib

Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks

DRUGTofacitinib

Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks

Locations(1)

Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.

Fuzhou, Fujian, China

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