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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• DRESS Syndrome

Interventions

Type	Name	Description
DRUG	Benralizumab 30 MG/ML [Fasenra]	Subcutaneous injection 30 mg at day 2, week 4 and week 8.
DRUG	Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride	Subcutaneous injection at day 2, week 4 and week 8

Timeline

• Start date: 2025-01-06
• Primary completion: 2029-01-05
• Completion: 2029-09-01
• First posted: 2024-12-16
• Last updated: 2025-01-17

Locations

1 site across 1 country: France