Trial Outcomes & Findings for Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN (NCT NCT06474078)
NCT ID: NCT06474078
Last Updated: 2025-09-16
Results Overview
Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
days
Results posted on
2025-09-16
Participant Flow
SCAR patients were enrolled in the clinical trial from 2022/08/01 to 2025/04/15 at Chang Gung Memorial Hospital in Taiwan.
SJS/TEN (n=20)
Participant milestones
| Measure |
Tofacitinib Treatment
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.
Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
Baseline characteristics by cohort
| Measure |
Tofacitinib Treatment
n=20 Participants
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.
Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
20 Participants
n=5 Participants
|
|
Blister/erosion
|
14 Participants
n=5 Participants
|
|
Fever, >38℃
|
11 Participants
n=5 Participants
|
|
Atypical target lesion
|
11 Participants
n=5 Participants
|
|
GPT, > 82 U/L
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: daysPopulation: We determined if the enrolled participants had SJS/TEN using the criteria and histopathological examinations.
Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.
Outcome measures
| Measure |
Tofacitinib Treatment
n=20 Participants
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.
Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily
|
|---|---|
|
Complete Skin Healing Time, Day, Medium [Full Range]
|
10.0 days
Interval 6.0 to 15.0
|
PRIMARY outcome
Timeframe: daysPopulation: We determined if the enrolled participants had SJS/TEN using the criteria and histopathological examinations.
Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.
Outcome measures
| Measure |
Tofacitinib Treatment
n=20 Participants
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.
Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily
|
|---|---|
|
Complete Skin Healing Time, Day, Mean [Full Range]
|
10.1 days
Interval 6.0 to 15.0
|
SECONDARY outcome
Timeframe: Duration of hospital stay up to 3 monthsLength of hospitalization and Duration of hospitalization days
Outcome measures
| Measure |
Tofacitinib Treatment
n=20 Participants
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.
Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily
|
|---|---|
|
Length of Hospitalization
|
22.4 days
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: up to 1 yearNumber of participants with mortality at 30 days, 3 months and 1 year. Mortality monitoring is considered for the underlying SJS/TEN disease.
Outcome measures
| Measure |
Tofacitinib Treatment
n=20 Participants
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.
Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily
|
|---|---|
|
Mortality
|
0 Participants
|
Adverse Events
Tofacitinib Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tofacitinib Treatment
n=20 participants at risk
Duration of hospital stay after tofacitinib treatment.
|
|---|---|
|
Hepatobiliary disorders
Abnormal liver function
|
15.0%
3/20 • 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.
AEs surveillance began at the initiation of tofacitinib and continued through three weeks after the final dose, serving as the predefined safety endpoint. The duration of clinical and laboratory monitoring as well as AEs evaluation ranged from 1 to 3 months. AEs monitoring pertains to post-tofacitinib treatment. 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place