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NCT Number: NCT06119490

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

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

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Key information

Conditions

Toxic Epidermal Necrolysis Chemically-Induced Disorders Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Erythema Erythema Multiforme Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Mouth Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stevens-Johnson Syndrome Stomatitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Abrocitinib

Drug

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®

tofacitinib

Drug

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

Other names: Solu-Medrol®

Primary outcomes

  1. Time to Reepithelization

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Ji

CONTACT

[email protected]

+86 18651619908

Peng Zhang

CONTACT

[email protected]

+86 13645096437

Sponsors and collaborators

Lead sponsor

Peng Zhang

Other

Registry information

Official study title

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

Acronym: TEN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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