NCT06119490

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
3mo left

Started Jul 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jul 2023Sep 2026

Study Start

First participant enrolled

July 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

October 23, 2023

Last Update Submit

November 22, 2023

Conditions

Toxic Epidermal Necrolysis

Outcome Measures

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).

    up to 8 week

Secondary Outcomes (1)

  • Adverse events

    up to 12 weeks

Study Arms (2)

Arocitinib-arm

OTHER

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

Tofacitinib-arm

OTHER

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

AbrocitinibDRUG

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®
Arocitinib-arm
TofacitinibDRUG

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®
Tofacitinib-arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
  • Patients need to be capable of participating in follow-up visits and treatment plans.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

abrocitinibMethylprednisolone Hemisuccinatetofacitinib

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Chao Ji

CONTACT

+86 18651619908jichaofy@fjmu.edu.cn

Peng Zhang

CONTACT

+86 13645096437396159837@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 7, 2023

Study Start

July 5, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

CN(1)