N/A
Completed N=20
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
Source: ClinicalTrials.gov NCT06474078 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Complete Skin Healing Time, Day, Medium [Full Range] — 10.0 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Skin Healing Time, Day, Medium [Full Range] |
10.0 | — |
| PRIMARY Complete Skin Healing Time, Day, Mean [Full Range] |
10.1 | — |
| SECONDARY Length of Hospitalization |
22.4 | — |
| SECONDARY Mortality |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06474078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.