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TENEvaluation 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

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What is being tested

Abrocitinib

+ Tofacitinib

Drug
Who is being recruted

Dermatitis+14

+ Drug Eruptions

+ Drug Hypersensitivity

From 18 to 70 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: July 2023
See protocol details

Summary

Principal SponsorPeng Zhang
Study ContactChao JiMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 5, 2023

Actual date on which the first participant was enrolled.

This study aims to explore how well a combination of medications works to treat toxic epidermal necrolysis, a severe skin condition. The medications being studied are methylprednisolone and two JAK inhibitors, abxitinib and tofacitinib. Toxic epidermal necrolysis can cause large portions of the skin to peel off, leading to serious health issues. Finding effective treatments is important because it can improve recovery and quality of life for those affected by this condition. In this study, participants receive the treatment involving methylprednisolone and the JAK inhibitors. The medications are administered to see how they work together to help heal the skin and improve symptoms. The study focuses on assessing both the effectiveness of this treatment combination and its safety for the participants. Researchers record how well the skin heals and monitor any side effects to understand the best way to help people with this condition.

Official TitleEvaluation 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
NCT06119490
Principal SponsorPeng Zhang
Study ContactChao JiMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDrug EruptionsDrug HypersensitivityErythemaErythema MultiformeHypersensitivityHypersensitivity, DelayedImmune System DiseasesStomatognathic DiseasesMouth DiseasesSkin DiseasesSkin Diseases, VesiculobullousStevens-Johnson SyndromeStomatitisSkin and Connective Tissue DiseasesChemically-Induced DisordersDrug-Related Side Effects and Adverse Reactions

Criteria

6 inclusion criteria required to participate
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.
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11 exclusion criteria prevent from participating
History of allergy to JAK inhibitors.
Pregnant or breastfeeding women.
Severe infectious conditions.
History of central nervous system demyelinating diseases.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Fuzhou, ChinaOpen Department of Dermatology, the First Affiliated Hospital of Fujian Medical University. in Google Maps
Recruiting
One Study Center