NCT06474078

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

Completed NA Results posted Last updated 16 September 2025

What this trial tests

NA trial testing Tofacitinib in Stevens-Johnson Syndrome in 20 participants. Completed in 20 June 2025.

Timeline

1 August 2022

Primary endpoint
20 June 2025

20 June 2025

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 August 2022
Primary completion	20 June 2025
Estimated completion	20 June 2025
Sites	1 location across Taiwan

Drugs / interventions tested

• Tofacitinib (tofacitinib) — full drug profile →

Conditions studied

• Stevens-Johnson Syndrome — all drugs for Stevens-Johnson Syndrome →
• Toxic Epidermal Necrolysis — all drugs for Toxic Epidermal Necrolysis →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 20 to 90, any sex, with Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Skin Healing Time, Day, Medium [Full Range] Primary · days

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

Group	Value	95% CI
Tofacitinib Treatment	10.0	6 – 15

Complete Skin Healing Time, Day, Mean [Full Range] Primary · days

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

Group	Value	95% CI
Tofacitinib Treatment	10.1	6 – 15

Length of Hospitalization Secondary · Duration of hospital stay up to 3 months

Length of hospitalization and Duration of hospitalization days

Group	Value	95% CI
Tofacitinib Treatment	22.4	± 15.6

Mortality Secondary · up to 1 year

Number of participants with mortality at 30 days, 3 months and 1 year. Mortality monitoring is considered for the underlying SJS/TEN disease.

Group	Value	95% CI
Tofacitinib Treatment	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious and other (not including serious) adverse events were assessed three weeks to three months. Moreover, all-cause mortality was assessed up to 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tofacitinib Treatment

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Tofacitinib Treatment
Abnormal liver function	Hepatobiliary disorders	—

Data from ClinicalTrials.gov NCT06474078 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring skin adverse events and mechanisms of apalutamide using data mining algorithms and network pharmacology.
   Chen Y, Huang L, Li W, Gu H, et al · · 2025 · cited 4× · PMID 40017595 · DOI 10.3389/fphar.2025.1517874