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).
Adult patients (minimum 18year-old)
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.
Patients <18 year-old
Patients with DRESS with REGIScar score <4
Patients without skin eruption at baseline
Eosinophils blood count <500/mm3 or < 0.5 G/L at baseline
Parallel
Benralizumab 30 MG/ML [Fasenra]
DrugSubcutaneous injection 30 mg at day 2, week 4 and week 8.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride
DrugSubcutaneous injection at day 2, week 4 and week 8
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)
Number of days spent in hospital for the management of DRESS syndrome
Percentage of body surface with cutaneous lesions due to DRESS and severity grade of skin involvement observed within the 52 weeks period
Percentage of body surface with cutaneous lesions recorded
Number and severity grade of organ lesions due to DRESS observed within the 52 weeks period
Dosage of blood eosinophils during the 52 weeks after inclusion
Number of flares or relapses of DRESS during a 52 week-period after inclusion
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University Hospital, Lille
Lead sponsor
AstraZeneca
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
