Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)
Condition(s) studied
Investigational drug(s) / intervention(s)
Benralizumab 30 MG/ML [Fasenra]: Subcutaneous injection 30 mg at day 2, week 4 and week 8.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Subcutaneous injection at day 2, week 4 and week 8
Study 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).
Eligibility
Primary outcome measure(s)
- 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) — from inclusion to 52 weeks
Number of days spent in hospital for the management of DRESS syndrome
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Delphine STAUMONT-SALLE | Lille | Nord |
More University Hospital, Lille trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06734884 on ClinicalTrials.gov ↗ ← All trials in France