Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DR… (NCT06734884) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)
France96 participantsStarted 2025-01-06
Plain-language summary
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/or 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients (minimum 18year-old)
✓. diagnosed at D0 (= baseline and inclusion) with DRESS defined by:
✓. 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
✓. 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)
✓. AND Fever ≥ 38°C at the time of the examination or notion of a thermal peak ≥ 38°C in the preceding 72 hours.
✓. At least 1 organ disorder compatible with the diagnosis of DRESS syndrome among the following disorders:
✓. With eosinophilia (blood eosinophil count ≥ 500/mm3 or ≥0.5 G/L).
✓. Patient having given written informed consent
Exclusion criteria
✕. Patients \<18 year-old
What they're measuring
1
Efficacity of an add-on treatment with benralizumab to decrease the total hospitalization for DRESS duration within a 52 weeks (W52) period in patients diagnosed with DRESS syndrome and treated with corticosteroids (CS)