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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502750-14-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab 30 MG/ML [Fasenra] | Drug | Subcutaneous injection 30 mg at day 2, week 4 and week 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from inclusion to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Adult patients (minimum 18year-old)
diagnosed at D0 (= baseline and inclusion) with DRESS defined by:
with a REGIScar score at D0 calculated at at least 4 (4 or 5: probable DRESS; >5: definite case of DRESS), see Annex: REGIScar criteria
Skin eruption with an onset considered as compatible with a DRESS syndrome according to the investigator's opinion after the uptake of one or several drug(s)
AND Fever ≥ 38°C at the time of the examination or notion of a thermal peak ≥ 38°C in the preceding 72 hours.
At least 1 organ disorder compatible with the diagnosis of DRESS syndrome among the following disorders:
Adenopathies present in at least 2 different sites and ≥ 1 cm in size
Acute hepatitis defined by :
Acute renal failure defined by :
Pulmonary impairment defined by:
With eosinophilia (blood eosinophil count ≥ 500/mm3 or ≥0.5 G/L).
Patient having given written informed consent
patient with social insurance
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine STAUMONT-SALLE, Professor, MD | Contact | +33320444145 | DRC@chu-lille.fr | |
| Japhete ELENGA KOANGA | Contact | +33320444145 | 30939 | japhete.elengakoanga@chu-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delphine STAUMONT-SALLE | Lille | Nord | 59000 | France |
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| Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride | Drug | Subcutaneous injection at day 2, week 4 and week 8 |
|
| 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D063926 | Drug Hypersensitivity Syndrome |
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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