Actively Recruiting
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
Led by Peng Zhang · Updated on 2023-11-28
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining methylprednisolone with two different JAK inhibitors, abrocitinib and tofacitinib, in treating toxic epidermal necrolysis (TEN). This early phase 1 study aims to compare these combinations to understand their impact on this severe skin condition. The study is open-label, non-randomized, and conducted at a single center. Participants receive methylprednisolone at a dose of 1 mg/kg of body weight per day combined with either abrocitinib 200 mg daily or tofacitinib 10 mg daily. Both treatments are given for a duration of two weeks. The study has two treatment arms, one for each JAK inhibitor, to assess their efficacy and safety when combined with methylprednisolone. During the study, researchers will monitor the time it takes for skin healing (reepithelization) over up to eight weeks. They will also observe any adverse events for up to twelve weeks. Participants will undergo regular follow-up visits and assessments, including monitoring blood parameters, liver and kidney function, to evaluate treatment effects and safety. The total participation duration varies depending on individual follow-up schedules.
CONDITIONS
Brief Title
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and above
- Diagnosed with Stevens-Johnson syndrome or toxic epidermal necrolysis according to RegiSCAR criteria
- Liver and kidney function within acceptable ranges
- Blood parameters including complete blood count, coagulation function, and platelet count within acceptable ranges
- Signed informed consent form acknowledging risks and potential benefits
- Ability to participate in follow-up visits and treatment plans
You will not qualify if you...
- 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 infection with CD4+ T cell count below 200/mL
- Active hepatitis B or C infection
- Coagulation disorders or tendency for thrombosis
- Significant abnormalities in blood routine indicators
- Liver or kidney dysfunction
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants receive daily intravenous methylprednisolone combined with either abrocitinib or tofacitinib tablets for 2 weeks.
Daily visits for 2 weeks (in-person)
Duration - Up to 12 weeks after treatment
Participants are monitored for safety and adverse events after treatment ends.
Periodic visits during 12 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
C
Chao Ji
P
Peng Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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