[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dress-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100572562","phase-2-interest-of-a-targeted-therapy-for-the-treatment-of-a-severe-form-of-hypersensitivity-to-drug-dress-syndrome-100572562",false,"NCT06734884","Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)","Efficacy and Safety of Anti-interleukin 5 Receptor Therapy (Benralizumab) in Patients With Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)","BENRADRESS","Inclusion Criteria:\n\n1. Adult patients (minimum 18year-old)\n2. diagnosed at D0 (= baseline and inclusion) with DRESS defined by:\n\n   1. with a REGIScar score at D0 calculated at at least 4 (4 or 5: probable DRESS; \\>5: definite case of DRESS), see Annex: REGIScar criteria\n   2. Skin eruption with an onset considered as compatible with a DRESS syndrome according to the investigator's opinion after the uptake of one or several drug(s)\n   3. AND Fever ≥ 38°C at the time of the examination or notion of a thermal peak ≥ 38°C in the preceding 72 hours.\n   4. At least 1 organ disorder compatible with the diagnosis of DRESS syndrome among the following disorders:\n\n      * Adenopathies present in at least 2 different sites and ≥ 1 cm in size\n      * Acute hepatitis defined by :\n\n        * Elevation of liver enzymes in serum: ALAT (Alanine Aminotransferase) and\u002For ASAT (Aspartate Aminotransferase)\n        * AND\u002FOR an increase in serum total bilirubin, according to the standards of the local analysis laboratory (in the absence of a history of liver disease: ASAT and\u002For ALAT ≥ 3N (=3 times normal)\n        * AND\u002FOR total bilirubin ≥ 2N\n      * Acute renal failure defined by :\n\n        * An increase in creatinine according to local laboratory standards\n        * AND a sterile cytobacteriological examination (in the absence of a history of renal disease: creatininaemia ≥ 1.5N\n        * AND\u002FOR increase in creatinine ≥ 0.3 mg\u002Fdl (or ≥ 26.5 mol\u002FL)\n        * AND\u002FOR urine output \\< 0.3 ml\u002Fkg\u002Fh (over ≥ 24h).\n      * Pulmonary impairment defined by:\n\n        * Oxygen saturation (SpO2) measured by pulse oximetry ≤ 95% in room air\n        * And\u002For the presence of an interstitial syndrome on a standard chest X-ray or a CT scan of the chest (in the absence of any other cause of lung damage).\n3. With eosinophilia (blood eosinophil count ≥ 500\u002Fmm3 or ≥0.5 G\u002FL).\n4. Patient having given written informed consent\n5. patient with social insurance\n\nExclusion Criteria:\n\n1. Patients \\<18 year-old\n2. Patients with DRESS with REGIScar score \\<4\n3. Patients without skin eruption at baseline\n4. Eosinophils blood count \\<500\u002Fmm3 or \\< 0.5 G\u002FL at baseline\n5. Patients with contra-indication to blood samples dedicated to the biocollection, according to the investigator's opinion\n6. Patients with contra-indication to stop the culprit drug(s) involved in DRESS\n7. Past history of hypersensitivity to biological drugs\n8. Patients who received a previous anti-IL5 or anti-IL5 receptor therapy within 5 half lives (= 4 months) before inclusion\n9. Patients with a contra-indication of topical corticosteroids (mainly a past history of contact eczema with clobetasol propionate)\n10. Pregnancy and lactation","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Drug Reaction with eosinophilia and Systemic Symptoms (DRESS) is a rare and severe multiorgan drug reaction whose pathophysiological mechanisms underlying remain unclear, but may involve the role of several immune cells like eosinophils. iIndeed,the number of eosinophils is increased in blood and\u002For in organs tiisues in at least 50% of patients with DRESS. There is no specific treatment available. The standard of care is corticosteroids, but they may be inefficient or poorly tolerated. The aim of this research is to find out whether a specific treatment of the immunological response in DRESS syndrome would be useful in combination with corticosteroids to speed up the recovery from DRESS syndrome and therefore reduce the total length of your hospital stay when your illness is being managed. This a multicenter, international, prospective, interventional study, double-blinded, placebo-controlled, randomized, in two balanced parallel groups, one receiving the standard of care (topical or systemic corticosteroids, according to the severity of DRESS syndrome) and the other one corticsoteroids and a targeted therapy against eosinophils (benralizumab, already available in other eosinophilic diseases like asthma).",[27],"DRESS Syndrome",[29,30,31,32,33],"DRESS syndrome","drug hypersensitivity","Eosinophil","Benralizumab","targeted therapy","NOT_YET_RECRUITING","2026-05-14",{"date":37,"type":38},"2026-05-15","ACTUAL",{"date":40,"type":21},"2027-01-06",{"date":42,"type":21},"2029-09-01",{"name":44,"class":45},"University Hospital, Lille","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100387851","origin-and-function-of-eosinophilic-polynuclear-during-dress-syndrome-100387851","NCT04330118","Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome","Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome","DRESSEO","Inclusion Criteria:\n\nGroup 1 (DRESS): adult with a diagnosis of DRESS based on the following four criteria:\n\n* Cutaneous rash occurring at least 24 hours and at most 2 months after continuous medication use\n* Fever over 38 degre celcius\n* At least one organ dysfunction among:\n* Lymphadenopathy\n* hepatitis\n* Pulmonary involvement\n* Cardiac involvement: myocarditis, pericarditis\n* Renal impairment\n* At least one of the following hematological anomalies:\n* Eosinophilia ≥ 500 \u002F mm3 .\n* RegiSCAR Score ≥ 4\n\nGroups 2 and 3 (Drug induced maculopapular exanthema without or with eosinophilia).\n\n* Adult with drug-induced rash\n* Without clinical criteria of severity defined by Djien among :\n* An evolution of more than 21 days\n* with organ damage as defined in group 1\n\nGroup 2 (MPE without eosinophilia): blood eosinophils \\\u003C 500 \u002F mm3\n\nGroup 3 (MPE with eosinophilia): blood eosinophils ≥ 500 \u002F mm3\n\nExclusion Criteria:\n\n* Other cause of eosinophilia including cancer, blood disease before the introduction of suspected molecule(s).\n* On going oral or local corticosteroid therapy, anti-leukotriene therapy (MONTELUKAST) by the month preceding the study;\n* Anti-IgE therapy (OMALIZUMAB, LIGELIZUMAB), anti-IL-5 therapy (MEPOLIZUMAB, BENRALIZUMAB) or anti-IL4 and \u002F or anti-IL13 therapy (DUPILUMAB, TRALOKINUMAB) in the 6 months preceding the study.\n* Any pregnant or lactating woman.\n* Contraindication related to the blood volume taken for the study.",true,{"count":57,"type":21},80,"OBSERVATIONAL","Drug Hypersensitivity Syndrome or DRESS for \"Drug Reaction with Eosinophilia and Systemic Symptoms\" is a serious drug allergy which can be life-threatening for patients with serious organ damage. The pathophysiology of DRESS is still not fully understood. In particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteria. Likewise, there is no data about the origin of eosinophils and few data are available concerning immune polarization of T-cells or the involvement of innate lymphoid cells type 2 in the recruitment of eosinophils. Our preliminary data on increase activation markers membrane expression of cutaneous eosinophils suggest that this approach could allow the identification of endotypes in which eosinophils are involved and contribute to organ damages. The correlation between tissue infiltration of eosinophils and their degree of activation would then justify the development of targeted therapeutic strategies in DRESS syndrome (anti-IL-5 therapy?). The aim of the project is: 1) Evaluate the activation status of circulating and cutaneous eosinophils in patients with DRESS compared with drug induced maculopapular exanthema without or with eosinophilia (but do not fulfill DRESS criteria) and healthy subjects; 2) Understand the pathophysiological mechanisms at the origin of this eosinophilia.",[61,27],"Drug Hypersensitivity",[29,63,64,65],"Drug hypersensitivity","eosinophils","allergy","RECRUITING","2026-04-21",{"date":69,"type":38},"2026-04-22",{"date":71,"type":38},"2020-07-15",{"date":73,"type":21},"2027-10",{"name":44,"class":45},11]