Stevens-Johnson SyndromeNCT06474078
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
A study testing Tofacitinib in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
- What is being tested?
- Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of Tofacitinib in Patients With Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
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.
Read the detailed description
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) belong to life-threatening severe cutaneous adverse drug reactions. SJS/TEN is classified by the extent of the detachment over the total body-surface area: SJS (<10%), SJS-TEN overlap (10%-30%), and TEN (>30%). TEN has the highest mortality (30-35%); SJS and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Currently, there is still no conclusive effective immunomodulator treatment for SJS/TEN. And, there is still a clinical unmet need for the treatment of SJS/TEN.
According to our past research reports, interleukin-15 (IL-15) plays an important role in SJS/TEN, which is related to disease severity and mortality. Janus kinase (JAK) inhibitors can inhibit the downstream JAK to inhibit the production and transmission of inflammatory cytokines, as a treatment for severe skin drug hypersensitivity reactions. Tofacitinib, a JAK1/3 inhibitor, is an intervention known to effectively treat several inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Notably, a recent study identified a potential therapeutic target with JAK-STAT pathway in a patient with recalcitrant and refractory drug rash with eosinophilia and systemic symptoms (DRESS). Based the current evidence, a targeting therapy to IL-15 by tofacitinib treatment are suggesting likely to be effective in treating SJS/TEN.
This is an "open label" study, all patients enrolled in the study will receive the active medication; meaning that there will not be a placebo or control group. The aims of this project are (1) to investigate the effect of tofacitinib treatment for SJS/TEN patients, including healing time, mortality rate, adverse events, beginning of re-epithelialization time, internal organ recovery time, and ocular complications, and (2) to investigate the molecular mechanism of SJS/TEN after tofacitinib treatment through collection of timed samples to include DNA, RNA, PBMCs, blister cells and supernatant and skin tissue.
The primary outcome of the study is the time to complete re-epithelialization as defined by complete absence of erosion on the skin. The secondary outcomes are to determine the time to beginning of epithelization (defined as the time to start re-epithelialization of the erosions on the skin and mucosa), the time to halting of progression of SJS/TEN (considered significant progression if there are any new blistering lesions or any new detached or detachable skin), mortality, length of hospitalization, ocular complications, infections, and adverse events. The investigators also determine the molecular and cellular mechanisms of SJS/TEN through collection of timed samples to include DNA, RNA, PBMCs, blister cells and supernatant and skin tissue.
- Being tested
- Tofacitinib
- Keywords
- JAK/STAT Pathway, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, JAK1/3 inhibitor, Tofacitinib
- Medical subject headings
- Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Also called XELJANZ
Dosage/Frequency: 5mg - 10mg, oral, twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: days
Secondary outcomes (2)
Length of Hospitalization
Length of hospitalization and Duration of hospitalization days
Measured: Duration of hospital stay up to 3 months
Mortality
Number of participants with mortality at 30 days, 3 months and 1 year. Mortality monitoring is considered for the underlying SJS/TEN disease.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Aug 2022
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stevens-Johnson SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Bing Chen, Chang Gung Memorial Hospital
- Investigators
- Chun Bing Chen, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474078
- Sponsor's protocol ID
- 202102411A3
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2024
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of Tofacitinib in Patients With Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
- ClinicalTrials.gov ID
- NCT06474078
- Acronym / sponsor ID
- 202102411A3
- Keywords
- JAK/STAT Pathway, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, JAK1/3 inhibitor, Tofacitinib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) belong to life-threatening severe cutaneous adverse drug reactions. SJS/TEN is classified by the extent of the detachment over the total body-surface area: SJS (<10%), SJS-TEN overlap (10%-30%), and TEN (>30%). TEN has the highest mortality (30-35%); SJS and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Currently, there is still no conclusive effective immunomodulator treatment for SJS/TEN. And, there is still a clinical unmet need for the treatment of SJS/TEN.
According to our past research reports, interleukin-15 (IL-15) plays an important role in SJS/TEN, which is related to disease severity and mortality. Janus kinase (JAK) inhibitors can inhibit the downstream JAK to inhibit the production and transmission of inflammatory cytokines, as a treatment for severe skin drug hypersensitivity reactions. Tofacitinib, a JAK1/3 inhibitor, is an intervention known to effectively treat several inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Notably, a recent study identified a potential therapeutic target with JAK-STAT pathway in a patient with recalcitrant and refractory drug rash with eosinophilia and systemic symptoms (DRESS). Based the current evidence, a targeting therapy to IL-15 by tofacitinib treatment are suggesting likely to be effective in treating SJS/TEN.
This is an "open label" study, all patients enrolled in the study will receive the active medication; meaning that there will not be a placebo or control group. The aims of this project are (1) to investigate the effect of tofacitinib treatment for SJS/TEN patients, including healing time, mortality rate, adverse events, beginning of re-epithelialization time, internal organ recovery time, and ocular complications, and (2) to investigate the molecular mechanism of SJS/TEN after tofacitinib treatment through collection of timed samples to include DNA, RNA, PBMCs, blister cells and supernatant and skin tissue.
The primary outcome of the study is the time to complete re-epithelialization as defined by complete absence of erosion on the skin. The secondary outcomes are to determine the time to beginning of epithelization (defined as the time to start re-epithelialization of the erosions on the skin and mucosa), the time to halting of progression of SJS/TEN (considered significant progression if there are any new blistering lesions or any new detached or detachable skin), mortality, length of hospitalization, ocular complications, infections, and adverse events. The investigators also determine the molecular and cellular mechanisms of SJS/TEN through collection of timed samples to include DNA, RNA, PBMCs, blister cells and supernatant and skin tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib treatment | Experimental | Drug: Tofacitinib1. 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibAlso: XELJANZDosage/Frequency: 5mg - 10mg, oral, twice daily | Drug | Tofacitinib treatment |
Primary outcome
Complete Skin Healing Time, Day, Medium [Full Range]
Time frame: 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.
Complete Skin Healing Time, Day, Mean [Full Range]
Time frame: 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.
2 secondary outcomes
Length of Hospitalization
Time frame: Duration of hospital stay up to 3 months
Mortality
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Bing Chen principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tofacitinib in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Skin Healing Time, Day, Medium [Full Range] (time frame: days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.