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RecruitingNCT06119490TENUpdated Nov 28, 2023

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

An Early Phase 1 interventional study of Abrocitinib and Tofacitinib in Toxic Epidermal Necrolysis, sponsored by Peng Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Peng Zhang · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Toxic Epidermal Necrolysis
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugAbrocitinib

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

    Also known as: Solu-Medrol®

  • DrugTofacitinib

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

    Also known as: Solu-Medrol®

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
    Fuzhou, Fujian 350000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06119490
Lead sponsor
Peng Zhang
Responsible party
Peng Zhang (Investigator, Fujian Provincial Hospital) — Sponsor-investigator
First posted
Nov 7, 2023
Start date
Jul 5, 2023
Primary completion
Jul 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Nov 28, 2023

Study contacts

Chao Ji
Contact
jichaofy@fjmu.edu.cn
+86 18651619908
Peng Zhang
Contact
396159837@qq.com
+86 13645096437

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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