Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Study Purpose

To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06119490
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peng Zhang
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Toxic Epidermal Necrolysis

Arms & Interventions

Arms

Other: Arocitinib-arm

Evaluation of the efficacy and safety of methylprednisolone combined with abrocitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with Arocitinib 200 mg daily.

Other: Tofacitinib-arm

Evaluation of the efficacy and safety of methylprednisolone combined with tofacitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with tofacitinib 10 mg daily.

Interventions

Drug: - Abrocitinib

Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks

Drug: - Tofacitinib

Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fuzhou, Fujian, China

Status

Recruiting

Address

Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.

Fuzhou, Fujian, 350000

Site Contact

Chao Ji

[email protected]

+86 18651619908

Clinical Trial Finder