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

Last updated: November 22, 2023
Sponsor: Peng Zhang
Overall Status: Active - Recruiting

Phase

1

Condition

Rash

Urticaria

Dry Eye Disease

Treatment

Tofacitinib

Abrocitinib

Clinical Study ID

NCT06119490
IECFOM-2023-400
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 and above.
  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 plateletcount, are within acceptable ranges.
  5. Patients must sign an informed consent form, understanding the risks and potentialbenefits of the treatment.
  6. Patients need to be capable of participating in follow-up visits and treatment plans.

Exclusion

Exclusion Criteria:

  1. History of allergy to JAK inhibitors.
  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.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Tofacitinib
Phase: 1
Study Start date:
July 05, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

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

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

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