An Early Phase 1 interventional study of Abrocitinib and Tofacitinib in Toxic Epidermal Necrolysis, sponsored by Peng Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Peng Zhang · Early Phase 1, Interventional, and Treatment
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
Exclusion Criteria:
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
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.
Drug: Tofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
Also known as: Solu-Medrol®
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Also known as: Solu-Medrol®
Time to Reepithelization
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).
Time frame: up to 8 week
Adverse events
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.
Time frame: up to 12 weeks
Plan to share: Undecided — The results will be published in a peer-reviewed scientific paper and the data sets analyzed in this study can be obtained from the first author.
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Peng Zhang