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

Toxic Epidermal Necrolysis Clinical Trial

— TEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119490
• Other study ID #: IECFOM-2023-400
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 5, 2023
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: Fujian Provincial Hospital
• Contact: Chao Ji
• Phone: +86 18651619908
• Email: jichaofy[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

Intervention

Drug:
• Abrocitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
• Tofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks

Locations

Country	Name	City	State
China	Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Peng Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 8 week
Secondary	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.	up to 12 weeks