Recruiting NCT06119490
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abrocitinib, Tofacitinib.
- Who it may be relevant to
- Registry conditions: Toxic Epidermal Necrolysis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
Interventions
- 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 - Drug Tofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Primary outcome measures
- Time to Reepithelization [Time frame: up to 8 week]
Secondary outcome measures (1)
- Adverse events [Time frame: up to 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Dermatology, the First Affiliated Hospital of Fujian Medical University. — Fuzhou
Identifiers
NCT: NCT06119490 · IECFOM-2023-400