NCT06734884: BENRADRESS

Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)

Not yet recruiting Phase 2 Last updated 17 January 2025

What this trial tests

Phase 2 trial testing Benralizumab 30 MG/ML [Fasenra] in DRESS Syndrome in 96 participants. Not yet recruiting.

Timeline

6 January 2025

Primary endpoint
5 January 2029

1 September 2029

Quick facts

Lead sponsor	University Hospital, Lille
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	96
Start date	6 January 2025
Primary completion	5 January 2029
Estimated completion	1 September 2029
Sites	1 location across France

Drugs / interventions tested

• Benralizumab 30 MG/ML [Fasenra] — full drug profile →
• Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride — full drug profile →

Conditions studied

• DRESS Syndrome — all drugs for DRESS Syndrome →

Sponsor

University Hospital, Lille

Who can join

18 and older, any sex, with DRESS Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.