Evaluating a treatment for toxic epidermal necrolysis using methylprednisolone and JAK inhibitors
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study
This study is testing if a combination of methylprednisolone and JAK inhibitors can help adults with toxic epidermal necrolysis feel better and stay safe from side effects.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fujian Provincial Hospital Academic / other |
| Drugs / interventions | abxitinib, tofacitinib |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06119490 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of combining methylprednisolone with the JAK inhibitors abrocitinib and tofacitinib for patients diagnosed with toxic epidermal necrolysis. Participants will be monitored for their response to the treatment and any potential side effects. The study will include adults aged 18 and older who meet specific health criteria and will require informed consent for participation. The trial is being conducted at the Department of Dermatology at the First Affiliated Hospital of Fujian Medical University.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with toxic epidermal necrolysis according to established criteria.
Not a fit: Patients with a history of allergy to JAK inhibitors or severe infectious conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from toxic epidermal necrolysis.
How similar studies have performed: While this approach is novel, similar studies involving JAK inhibitors have shown promise in treating other severe skin conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 and above. 2. Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria. 3. Liver and kidney function is within acceptable ranges. 4. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges. 5. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment. 6. Patients need to be capable of participating in follow-up visits and treatment plans. Exclusion Criteria: 1. History of allergy to JAK inhibitors. 2. Pregnant or breastfeeding women. 3. Severe infectious conditions. 4. History of central nervous system demyelinating diseases. 5. History of lymphoproliferative diseases. 6. Active and latent tuberculosis. 7. HIV carriers with a CD4+ T cell count lower than (\<200/mL). 8. Active HBV/HCV infection. 9. Coagulation disorders or a tendency for thrombosis. 10. Significant abnormalities in blood routine indicators. 11. Liver or kidney dysfunction.
Where this trial is running
Fuzhou, Fujian
- Department of Dermatology, the First Affiliated Hospital of Fujian Medical University. — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Chao Ji
- Email: jichaofy@fjmu.edu.cn
- Phone: +86 18651619908
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.