Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN

NCT06474078 | Completed Results DMC

• 1 other identifier: 202102411A3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effect of tofacitinib in patients with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The primary outcome of the study is the time to complete re-epithelialization. The secondary outcomes are to determine mortality, length of hospitalization, adverse events, the time to beginning of epithelization, the time to halting of progression of SJS/TEN, ocular complications, and infections.

Conditions

Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis

Keywords

JAK/STAT Pathway; Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis; JAK1/3 inhibitor; Tofacitinib

Outcome Measures

Primary Outcomes (2)

• Complete Skin Healing Time, Day, Medium [Full Range]

  Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.

  days

• Complete Skin Healing Time, Day, Mean [Full Range]

  Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.

  days

Secondary Outcomes (2)

• Length of Hospitalization

  Duration of hospital stay up to 3 months

• Mortality

  up to 1 year

Study Arms (1)

Tofacitinib treatment

EXPERIMENTAL

1. Meet the conditions of inclusion and exclusion, seek the consent of the patient 2. Fill out the case report form 3. Blood test and physiological assessment, and do serum granulysin concentration and peripheral blood mononuclear spherical granulysin expression analysis 4. Tofacitinib administration: The experimental group received tofacitinib 5mg-10mg, twice daily, for the first week; and maintained tofacitinib 5mg-10mg, daily, for the second week.

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Dosage/Frequency: 5mg - 10mg, oral, twice daily

Also known as: XELJANZ

Tofacitinib treatment

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign inform consent form
• Subject has been diagnosed with Stevens-Johnson syndrome or toxic epidermal necrolysis by at least two dermatologists.
• Male or female aged over 20 years old and under 90 years old.

You may not qualify if:

• Subject or legally authorized representative is not willing to provide informed consent.
• Women who are pregnant or breastfeeding
• Subject has an active, untreated, or serious infectious disease that is ineffective in treatment, such as sepsis.
• Subject suffers from severe life-threatening cardiac arrhythmia, such as ventricular tachycardia, have had myocardial infarction (myocardial infarction), severe hypertension that has not responded to treatment within the past week, or other cardiologist diagnosed severe cardiovascular disease
• Subject has active viral hepatitis
• Subject has active tuberculosis
• Subject received live vaccination during the illness

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Chun Bing Chen
• Organization: Chang Gung Memorial Hospital

chunbing.chen@gmail.com

03-3281200

Study Officials

• Chun Bing Chen

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: August 1, 2022
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Locations

TW (1)