Toxic Epidermal NecrolysisEarly Phase 1TENNCT06119490
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
A Early Phase 1 study testing Abrocitinib and Tofacitinib in people with Toxic Epidermal Necrolysis, run by Peng Zhang at 1 site in China.
Trial summary
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Toxic Epidermal Necrolysis
- What is being tested?
- Abrocitinib and Tofacitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to Sep 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above.
- Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
- Liver and kidney function is within acceptable ranges.
- Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
- Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
- Patients need to be capable of participating in follow-up visits and treatment plans.
Who cannot join
- History of allergy to JAK inhibitors.
- Pregnant or breastfeeding women.
- Severe infectious conditions.
- History of central nervous system demyelinating diseases.
- History of lymphoproliferative diseases.
- Active and latent tuberculosis.
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- HIV carriers with a CD4+ T cell count lower than (<200/mL).
- Active HBV/HCV infection.
- Coagulation disorders or a tendency for thrombosis.
- Significant abnormalities in blood routine indicators.
- Liver or kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
Fuzhou, Fujian, 350000
Chao Ji, +86 18651619908, jichaofy@fjmu.edu.cn
Peng Zhang, +86 13645096437, 396159837@qq.com
About this study
Official title: 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
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
- Conditions
- Toxic Epidermal Necrolysis
- Being tested
- Abrocitinib, 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.
AbrocitinibDrug
Also called Solu-Medrol®
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
TofacitinibDrug
Also called Solu-Medrol®
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arocitinib-arm | Other | 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. Receives: Drug: Abrocitinib |
| Tofacitinib-arm | Other | 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. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reepithelization
duration from initiation of treatment to the point when skin detachment and erosions were no longer observed (negative Nikolsky's sign). Meanwhile, skin islands started to regenerate and replace the damaged superficial epithelia in local skin or mucous lesions (approximately 20% of the maximum BSA).
Measured: up to 8 week
Secondary outcomes (1)
Adverse events
The common adverse effects associated with treatments including elevated blood pressure, elevated blood glucose, gastrointestinal bleeding, electrolyte disturbance, and mucocutaneous infections were closely monitored during their hospitalization. All patients in both groups were followed up for 4 weeks to monitor the associated adverse effects.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 Jul 2023
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic Epidermal NecrolysisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Zhang, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119490
- Sponsor's protocol ID
- IECFOM-2023-400
- Acronym
- TEN
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results will be published in a peer-reviewed scientific paper and the data sets analyzed in this study can be obtained from the first author.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06119490
- Acronym / sponsor ID
- TEN / IECFOM-2023-400
- Conditions
- Toxic Epidermal Necrolysis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peng ZhangUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arocitinib-arm | Other | Drug: AbrocitinibEvaluation 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. |
| Tofacitinib-arm | Other | Drug: TofacitinibEvaluation 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 and above.
- Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
- Liver and kidney function is within acceptable ranges.
- Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
- Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
Key exclusion criteria (11 listed)
- History of allergy to JAK inhibitors.
- Pregnant or breastfeeding women.
- Severe infectious conditions.
- History of central nervous system demyelinating diseases.
- History of lymphoproliferative diseases.
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 |
|---|---|---|
| AbrocitinibAlso: Solu-Medrol®Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks | Drug | Arocitinib-arm |
| TofacitinibAlso: Solu-Medrol®Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks | Drug | Tofacitinib-arm |
Primary outcome
Time to Reepithelization
Time frame: up to 8 week
duration from initiation of treatment to the point when skin detachment and erosions were no longer observed (negative Nikolsky's sign). Meanwhile, skin islands started to regenerate and replace the damaged superficial epithelia in local skin or mucous lesions (approximately 20% of the maximum BSA).
1 secondary outcome
Adverse events
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Undecided. The results will be published in a peer-reviewed scientific paper and the data sets analyzed in this study can be obtained from the first author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Abrocitinib and Tofacitinib in people with Toxic Epidermal Necrolysis, run by Peng Zhang at 1 site in China.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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 China. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Ji (+86 18651619908, jichaofy@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reepithelization (time frame: up to 8 week). 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 28 Nov 2023.