DRESS SyndromePhase 2BENRADRESSNCT06734884
Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)
A Phase 2 study testing Benralizumab 30 MG/ML [Fasenra] in people with DRESS Syndrome, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DRESS Syndrome
- What is being tested?
- Benralizumab 30 MG/ML [Fasenra]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2027to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Adenopathies present in at least 2 different sites and ≥ 1 cm in size
- Acute hepatitis defined by :
- Elevation of liver enzymes in serum: ALAT (Alanine Aminotransferase) and/or ASAT (Aspartate Aminotransferase)
- AND/OR an increase in serum total bilirubin, according to the standards of the local analysis laboratory (in the absence of a history of liver disease: ASAT and/or ALAT ≥ 3N (=3 times normal)
- AND/OR total bilirubin ≥ 2N
- Acute renal failure defined by :
- An increase in creatinine according to local laboratory standards
- AND a sterile cytobacteriological examination (in the absence of a history of renal disease: creatininaemia ≥ 1.5N
- AND/OR increase in creatinine ≥ 0.3 mg/dl (or ≥ 26.5 mol/L)
- AND/OR urine output \< 0.3 ml/kg/h (over ≥ 24h).
- Pulmonary impairment defined by:
- Oxygen saturation (SpO2) measured by pulse oximetry ≤ 95% in room air
- And/or the presence of an interstitial syndrome on a standard chest X-ray or a CT scan of the chest (in the absence of any other cause of lung damage).
- With eosinophilia (blood eosinophil count ≥ 500/mm3 or ≥0.5 G/L).
- Patient having given written informed consent
- patient with social insurance
Who cannot join
- Patients \<18 year-old
- Patients with DRESS with REGIScar score \<4
- Patients without skin eruption at baseline
- Eosinophils blood count \<500/mm3 or \< 0.5 G/L at baseline
- Patients with contra-indication to blood samples dedicated to the biocollection, according to the investigator's opinion
- Patients with contra-indication to stop the culprit drug(s) involved in DRESS
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- Past history of hypersensitivity to biological drugs
- Patients who received a previous anti-IL5 or anti-IL5 receptor therapy within 5 half lives (= 4 months) before inclusion
- Patients with a contra-indication of topical corticosteroids (mainly a past history of contact eczema with clobetasol propionate)
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Delphine STAUMONT-SALLE
Lille, Nord, 59000
Delphine STAUMONT-SALLE, MD, Professor, +33320444145, DRC@chu-lille.fr
Delphine STAUMONT-SALLE, MD, Professor
About this study
Official title: Efficacy and Safety of Anti-interleukin 5 Receptor Therapy (Benralizumab) in Patients With Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)
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
- Being tested
- Benralizumab 30 MG/ML [Fasenra], Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride
- Keywords
- DRESS syndrome, drug hypersensitivity, Eosinophil, Benralizumab, targeted therapy
- Medical subject headings
- Drug Hypersensitivity Syndrome, Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benralizumab 30 MG/ML [Fasenra]Drug
Subcutaneous injection 30 mg at day 2, week 4 and week 8.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium ChlorideDrug
Subcutaneous injection at day 2, week 4 and week 8
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Not described Receives: Drug: Benralizumab 30 MG/ML [Fasenra] |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from inclusion to 52 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start6 Jan 2027 (estimated)
- Primary completion5 Jan 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DRESS SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734884
- Sponsor's protocol ID
- 2020_57
- Other IDs
- 2022-502750-14-00
- Acronym
- BENRADRESS
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anti-interleukin 5 Receptor Therapy (Benralizumab) in Patients With Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)
- ClinicalTrials.gov ID
- NCT06734884
- Acronym / sponsor ID
- BENRADRESS / 2020_57
- Conditions
- DRESS Syndrome
- Keywords
- DRESS syndrome, drug hypersensitivity, Eosinophil, Benralizumab, targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 6 Jan 2027 (estimated)
- Primary completion
- 5 Jan 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Drug: Benralizumab 30 MG/ML [Fasenra] |
| Placebo | Placebo comparator | Drug: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adult patients (minimum 18year-old)
- diagnosed at D0 (= baseline and inclusion) with DRESS defined by:
- With eosinophilia (blood eosinophil count ≥ 500/mm3 or ≥0.5 G/L).
- Patient having given written informed consent
- patient with social insurance
Key exclusion criteria (10 listed)
- Patients \<18 year-old
- Patients with DRESS with REGIScar score \<4
- Patients without skin eruption at baseline
- Eosinophils blood count \<500/mm3 or \< 0.5 G/L at baseline
- Patients with contra-indication to blood samples dedicated to the biocollection, according to the investigator's opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benralizumab 30 MG/ML [Fasenra]Subcutaneous injection 30 mg at day 2, week 4 and week 8. | Drug | Benralizumab |
| Placebo Comparator: Placebo-Control Arm 0.9% Sodium ChlorideSubcutaneous injection at day 2, week 4 and week 8 | Drug | Placebo |
Primary outcome
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)
Time frame: from inclusion to 52 weeks
Number of days spent in hospital for the management of DRESS syndrome
5 secondary outcomes
Percentage of body surface with cutaneous lesions due to DRESS and severity grade of skin involvement observed within the 52 weeks period
Time frame: 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
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.
Dosage of blood eosinophils during the 52 weeks after inclusion
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.
Number of flares or relapses of DRESS during a 52 week-period after inclusion
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.
Consumption of topical or systemic corticosteroids during a 52 week-period after inclusion
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benralizumab 30 MG/ML [Fasenra] in people with DRESS Syndrome, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine STAUMONT-SALLE, Professor, MD (+33320444145, DRC@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: from inclusion to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.