Delphine STAUMONT-SALLE
Lille, Nord, 59000, France
Location contact
Delphine STAUMONT-SALLE, MD, Professor
CONTACT
Delphine STAUMONT-SALLE, MD, Professor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06734884
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Lille, Nord, 59000, France
Delphine STAUMONT-SALLE, MD, Professor
CONTACT
Delphine STAUMONT-SALLE, MD, Professor
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection 30 mg at day 2, week 4 and week 8.
Subcutaneous injection at day 2, week 4 and week 8
Time frame: from inclusion to 52 weeks
Number of days spent in hospital for the management of DRESS syndrome
Time frame: at Day4, Day 7, Week 2, Week 4, Week 12, Week 24 and Week 52
Percentage of body surface with cutaneous lesions recorded
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.
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.
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.
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
expressed in weight in grammes
Contact information is provided by the study sponsor or research team.
Delphine STAUMONT-SALLE, Professor, MD
CONTACT
Japhete ELENGA KOANGA
CONTACT
+33320444145 ext. 30939
University Hospital, Lille
Other
Efficacy and Safety of Anti-interleukin 5 Receptor Therapy (Benralizumab) in Patients With Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)
Acronym: BENRADRESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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