[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"toxic-epidermal-necrolysis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:toxic-epidermal-necrolysis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100601451","phase-1-new-therapeutic-target-for-toxic-epidermal-necrolysis-ten-using-anti-cd38-monoclonal-antibodies-100601451",false,"NCT07110662","New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.","New Therapeutic Approach to Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Antibodies in the Active Phase of the Disease - Phase I\u002FII Study to Assess the Tolerance and Efficacy of DARATUMUMAB.","NET-CD38","Inclusion Criteria:\n\n* Adult, over 18 years old, with drug-induced SJS\u002FNET, proven or very strongly suspected (indirect argument of certainty) and confirmed by the evaluator.\n* SJS or NET or overlap syndrome evolving for less than 7 days prior to inclusion and with a progression of the detachment or rash observed within 48 hours prior to DARATUMUMAB treatment.\n* Negative hepatitis B screening (HBs, anti HBs and HBc).\n* The patient (or a trusted support person, family member, or close relative in case of emergency) must be capable of understanding the objectives of the trial and must have given free, informed, and express consent.\n* Patient affiliated to the Social Security system or benefiting from a similar system.\n* Negative beta HCG pregnancy test for women of childbearing potential and agreement to use effective contraception during the study and up to 3 months after stopping DARATUMUMAB treatment.\n\nExclusion Criteria:\n\n* Patient with Lyell syndrome induced by immunotherapy.\n* Known hypersensitivity to the active substance (DARZALEX) or to one of the excipients (L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 20 Sorbitol -E420).\n* Patient with known hereditary fructose intolerance (HFI).\n* Patient with known history of chronic obstructive pulmonary disease (COPD).\n* Patient admitted with septic shock.\n* PMNs \\\u003C 1,500 \u002Fmm3 on CBC at inclusion visit.\n* Pregnant or breast-feeding women.\n* Patient under protective measures (safeguard, curatorship, guardianship) or deprived of liberty.","ALL","18 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Toxic Epidermal Necrolysis (TEN) are rare diseases that are dermatologic emergencies characterized by widespread epidermal necrosis and sloughing of skin. A hundred patients are affected each year in France. The main symptom is bullous and skin detachment \\> 10% which gradually progresses to extensive necrosis of the 100% BSA epidermis. The mortality rate is around 15-20% due to visceral inflammatory injuries and serious bacterial infections. The morbidity is also very important (92% at 1 year), especially ophthalmologic with high risk of blindness. There is currently no effective treatment.\n\nOur team recently demonstrated that the severity of the disease correlates with the quantity and quality of CD8+ T lymphocytes which are activated in the active phase of disease. An activation marker has been identified, the CD38 receptor, which is very strongly expressed on the T clones responsible for the disease in the skin or blood of patients The CD38 receptor is the target of several commercial therapeutic antibodies, including DARATUMUMAB, which is currently used for the treatment of myeloma. DARATUMUMAB is a depleting antibody that eliminates cells strongly expressing this receptor.\n\nThe hypothesis is that a single intravenous infusion of DARATUMUMAB upon hospital admission of a patient with drug-induced NET would eliminate pathogenic T cells, thereby slowing disease progression, severity (% BSA with skin detachment, mortality rate) and sequelae.",[28,29,30],"Toxic Epidermal Necrolysis","Immunotherapy","Cutaneous Adverse Drug Reactions (CADR)",[32,33,34,35,36,37],"Toxic Epidermal Necrolysis (TEN)","Stevens-Johnson Syndrome (SJS)","anti-CD38+","DARATUMUMAB","Simon design","Lyell syndrome","NOT_YET_RECRUITING","2025-07-30",{"date":41,"type":42},"2025-08-07","ACTUAL",{"date":44,"type":21},"2025-10-29",{"date":46,"type":21},"2029-04-29",{"name":48,"class":49},"Hospices Civils de Lyon","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":50},"100417093","phase-1-lyell-syndrome-mesenchymal-stromal-cells-treatment-100417093","NCT04711200","LYell SYndrome MEsenchymal Stromal Cells Treatment","Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial","LYSYME","Inclusion Criteria:\n\n* Patients ≥ 18 and ≤ 75 years-old\n* Admission ≤ 10 days after the index date (date of the first symptoms of the disease)\n* Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine\n* At least 10 % of detachable-detached body surface area at any time during the first 10 days after the index date (date of the first symptoms of the disease)\n* Who, after the nature of the study has been explained to them or a support person (if applicable), and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* History of malignant disease within the past ten years and or presence of metastasis\n* Positive serology for HIV\n* Active infection for hepatitis B or C\n* Detection of Coronavirus SARS CoV-2 RNA on admission (positive RT-PCR), if performed in the usual care\n* Decompensated cardiac failure\n* Uncontrolled epilepsia\n* Previous history of allogenic bone marrow transplantation\n* Participation in other interventional drug research Patient deprived of liberty by a judicial or administrative decision or under the protection of justice\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule\n* Patient under tutorship or curatorship\n* Patient under psychiatric care according to art. L1121-6 CSP","75 Years",{"count":61,"type":21},15,[24,25],"Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous adverse reactions (SCARs) to drugs.\n\nTo date, no curative drug has demonstrated with a good level of evidence its ability to promote SJS and TEN healing and could contribute to earlier reepithelialisation. Mesenchymal stroma cells (MSCs) therapy represents a new therapeutic approach. eg, in patients with cardiovascular diseases, neurological diseases, renal transplantation, lung diseases as acute respiratory distress syndrome.\n\nRecently, MSCs have been proposed in both burn wound healing with a significantly decrease of the unhealed burn area and in cutaneous radiation.\n\nMoreover, MSCs have immunomodulation properties potentially effective in refractory acute and chronic graft versus host disease (GVHD) by improving thymic function and induction of Tregs. Indeed, MSCs are able to migrate to inflamed tissues after stimulation by pro-inflammatory cytokines and to modulate the local inflammatory reactions. MSCs have also demonstrated their ability to promote tissue remodelling, angiogenesis and immunomodulation through either differentiation or secretion of several growth factors such as VEGF, basic FGF and various cytokines.\n\nTherefore, combining their immunomodulation effect and secretion of soluble factors involved in wound repair, MSCs might be valuable as a cell therapy strategy for promoting cutaneous healing in SJS-TEN syndrome and subsequently decrease the morbi-mortality.",[65,66,28,67,68,69],"Epidermal Necrolysis","Lyell Syndrome","Overlap Syndrome","Mesenchymal Stromal Cells","Adipose Derived Stromal Cells",[71,37,72,73,74,75],"Epidermal necrolysis","toxic epidermal necrolysis","Overlap syndrome","Mesenchymal stromal cells","Adipose derived stromal cells","RECRUITING","2025-07-29",{"date":79,"type":42},"2025-08-01",{"date":81,"type":42},"2024-04-15",{"date":83,"type":21},"2027-04",{"name":85,"class":49},"Assistance Publique - Hôpitaux de Paris",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":50},"100525265","early-phase-1-evaluation-of-the-efficacy-and-safety-of-methylprednisolone-combined-with-the-jak-inhibitors-in-the-treatment-of-toxic-epidermal-necrolysis-100525265","NCT06119490","Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis","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","TEN","Inclusion Criteria:\n\n1. Age 18 and above.\n2. Diagnosed with SJS\u002FTEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.\n3. Liver and kidney function is within acceptable ranges.\n4. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.\n5. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.\n6. Patients need to be capable of participating in follow-up visits and treatment plans.\n\nExclusion Criteria:\n\n1. History of allergy to JAK inhibitors.\n2. Pregnant or breastfeeding women.\n3. Severe infectious conditions.\n4. History of central nervous system demyelinating diseases.\n5. History of lymphoproliferative diseases.\n6. Active and latent tuberculosis.\n7. HIV carriers with a CD4+ T cell count lower than (\\\u003C200\u002FmL).\n8. Active HBV\u002FHCV infection.\n9. Coagulation disorders or a tendency for thrombosis.\n10. Significant abnormalities in blood routine indicators.\n11. Liver or kidney dysfunction.","70 Years",{"count":96,"type":21},30,[98],"EARLY_PHASE1","To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis",[28],"2023-11-22",{"date":103,"type":42},"2023-11-28",{"date":105,"type":42},"2023-07-05",{"date":107,"type":21},"2026-09",{"name":109,"class":49},"Peng Zhang"]