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

Early Phase 1

Recruiting

• Conditions: Toxic Epidermal Necrolysis
• Interventions: Drug: Abrocitinib; Drug: Tofacitinib

• Registration Number: NCT06119490
• Lead Sponsor: Peng Zhang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-05
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-31
• Status Verified: 2023-11
• Study First Posted: 2023-11-07
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28
• Primary Completion: 2026-07
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age 18 and above.
2. Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
3. Liver and kidney function is within acceptable ranges.
4. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
5. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
6. Patients need to be capable of participating in follow-up visits and treatment plans.

Exclusion Criteria

1. History of allergy to JAK inhibitors.
2. Pregnant or breastfeeding women.
3. Severe infectious conditions.
4. History of central nervous system demyelinating diseases.
5. History of lymphoproliferative diseases.
6. Active and latent tuberculosis.
7. HIV carriers with a CD4+ T cell count lower than (<200/mL).
8. Active HBV/HCV infection.
9. Coagulation disorders or a tendency for thrombosis.
10. Significant abnormalities in blood routine indicators.
11. Liver or kidney dysfunction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arocitinib-arm	Abrocitinib	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.
Tofacitinib-arm	Tofacitinib	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.

Primary Outcome Measures

Name	Time	Method
Time to Reepithelization	up to 8 week	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).

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 12 weeks	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.

Trial Locations

Locations (1)

Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.; 🇨🇳 Fuzhou, Fujian, China