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

Sponsor
Peng Zhang (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119490
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
37.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: a Single-arm, Open, Single-center Study
Actual Study Start Date :
Jul 5, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: a single-arm, open, single-center study

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.

Drug: Abrocitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
Other Names:
  • Solu-Medrol®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Reepithelization [up to 8 week]

      duration from initiation of treatment to the point when skin detachment and erosions were no longer observed (negative Nikolsky's sign). Meanwhile, skin islands started to regenerate and replace the damaged superficial epithelia in local skin or mucous lesions (approximately 20% of the maximum BSA).

    Secondary Outcome Measures

    1. Adverse events [up to 12 weeks]

      The common adverse effects associated with treatments including elevated blood pressure, elevated blood glucose, gastrointestinal bleeding, electrolyte disturbance, and mucocutaneous infections were closely monitored during their hospitalization. All patients in both groups were followed up for 4 weeks to monitor the associated adverse effects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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:

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Dermatology, the First Affiliated Hospital of Fujian Medical University. Fuzhou Fujian China 350000

    Sponsors and Collaborators

    • Peng Zhang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peng Zhang, Investigator, Fujian Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT06119490
    Other Study ID Numbers:
    • IECFOM-2023-400
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Stevens-Johnson Syndrome
    Methylprednisolone Hemisuccinate
    Abrocitinib

    Study Results

    No Results Posted as of Nov 7, 2023