A Phase 2 interventional study of Benralizumab 30 MG/ML [Fasenra] and Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride in DRESS Syndrome, sponsored by University Hospital, Lille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University Hospital, Lille · Phase 2, Interventional, and Treatment
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).
66 studies on the registry are indexed under Drug Hypersensitivity; 20 are open to participants now.
This study's planned enrollment of 96 is below the median of 135 across 37 interventional studies indexed under Drug Hypersensitivity.
Browse Drug Hypersensitivity studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
diagnosed at D0 (= baseline and inclusion) with DRESS defined by:
At least 1 organ disorder compatible with the diagnosis of DRESS syndrome among the following disorders:
Acute hepatitis defined by :
Acute renal failure defined by :
Pulmonary impairment defined by:
Exclusion Criteria:
Drug: Benralizumab 30 MG/ML [Fasenra]
Drug: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride
Subcutaneous injection 30 mg at day 2, week 4 and week 8.
Subcutaneous 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
Time frame: from inclusion to 52 weeks
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
Time frame: at Day4, Day 7, Week 2, Week 4, Week 12, Week 24 and Week 52
Number and severity grade of organ lesions due to DRESS observed within the 52 weeks period
Time frame: Total number of organ lesions within 52 weeks. These organ lesions will be recorded at Day 4, Day7, Week 2, Week 4, Week 12, Week 24 and Week 52.
Dosage of blood eosinophils during the 52 weeks after inclusion
Time frame: number of cells per mm3 or per liter) performed at baseline (D0 = prior treatment), and at Day 2, Day 4, Day 7, Week 2, Week 4, Week 8, Week 12, Week 24, Week 52.
Number of flares or relapses of DRESS during a 52 week-period after inclusion
Time frame: Total number of exacerbation/worsening or occurrence/reappearance of DRESS signs identified within the Week 52 period and recorded at Day 2, Day 4, Day 7, Week 2, Week 4, Week 8, Week 12, Week 24, Week 52.
Consumption of topical or systemic corticosteroids during a 52 week-period after inclusion
expressed in weight in grammes
Time frame: Total quantity of superpotent topical or systemic corticosteroids (CS) used at Day 7, Week 2, Week 4, Week 8, Week 12, Week 24, Week 52
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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Drug Hypersensitivity Syndrome
University Hospital, Lille