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

November 22, 2023 updated by: Peng Zhang

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
Other Names:
  • Solu-Medrol®
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.
Drug: Tofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Other Names:
  • Solu-Medrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reepithelization
Time Frame: 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).
up to 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peng Zhang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECFOM-2023-400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The results will be published in a peer-reviewed scientific paper and the data sets analyzed in this study can be obtained from the first author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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