Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeng Zhang

About this trial

To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of allergy to JAK inhibitors.

Pregnant or breastfeeding women.

Severe infectious conditions.

History of central nervous system demyelinating diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abrocitinib

    Drug

    Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks

  • Tofacitinib

    Drug

    Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arocitinib-armOther 1 intervention
Group B: Tofacitinib-armOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peng Zhang

Lead sponsor

Fujian Provincial Hospital

Sponsor institution