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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
RECRUITING
Fuzhou
Contact Information
Primary
Chao Ji
jichaofy@fjmu.edu.cn
+86 18651619908
Backup
Peng Zhang
396159837@qq.com
+86 13645096437
Time Frame
Start Date: 2023-07-05
Estimated Completion Date: 2026-09
Participants
Target number of participants: 30
Treatments
Other: Arocitinib-arm
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.
Other: Tofacitinib-arm
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.
Related Therapeutic Areas
Sponsors
Leads: Peng Zhang