Evaluating Tofacitinib for Patients with Severe Skin Reactions
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)
This study is testing if tofacitinib can help people with severe skin reactions like Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis heal faster and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | tofacitinib |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT06474078 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of tofacitinib in treating patients diagnosed with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), both of which are severe skin reactions with high mortality rates. The primary focus is on the time to complete re-epithelialization, while secondary outcomes include mortality rates, length of hospitalization, and complications. The study is based on the hypothesis that tofacitinib, a JAK1/3 inhibitor, can effectively modulate the immune response and improve patient outcomes in these life-threatening conditions. Participants will be monitored for various clinical endpoints to evaluate the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 90 who have been diagnosed with SJS or TEN by at least two dermatologists.
Not a fit: Patients with active infections, severe cardiovascular diseases, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and reduce mortality rates for patients suffering from SJS and TEN.
How similar studies have performed: While there is limited research specifically targeting SJS/TEN with JAK inhibitors, similar approaches in treating severe inflammatory conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willing to sign inform consent form 2. Subject has been diagnosed with Stevens-Johnson syndrome or toxic epidermal necrolysis by at least two dermatologists. 3. Male or female aged over 20 years old and under 90 years old. Exclusion Criteria: 1. Subject or legally authorized representative is not willing to provide informed consent. 2. Women who are pregnant or breastfeeding 3. Subject has an active, untreated, or serious infectious disease that is ineffective in treatment, such as sepsis. 4. 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 5. Subject has active viral hepatitis 6. Subject has active tuberculosis 7. Subject received live vaccination during the illness
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chun Bing Chen — Chang Gung Memorial Hospital
- Study coordinator: Chun Bing Chen
- Email: chunbing.chen@gmail.com
- Phone: 03-3281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.