Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474078
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-19
Brief Title:
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJSTEN
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 SJSTEN ocular complications and infections
Detailed Description:
Stevens-Johnson syndrome SJS and toxic epidermal necrolysis TEN belong to life-threatening severe cutaneous adverse drug reactions SJSTEN 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 SJSTEN And there is still a clinical unmet need for the treatment of SJSTEN
According to our past research reports interleukin-15 IL-15 plays an important role in SJSTEN 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 JAK13 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 SJSTEN
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 SJSTEN 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 SJSTEN 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 SJSTEN 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 SJSTEN through collection of timed samples to include DNA RNA PBMCs blister cells and supernatant and skin tissue
According to our past research reports interleukin-15 IL-15 plays an important role in SJSTEN 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 JAK13 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 SJSTEN
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 SJSTEN 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 SJSTEN 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 SJSTEN 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 SJSTEN through collection of timed samples to include DNA RNA PBMCs blister cells and supernatant and skin tissue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None