New drug could shorten hospital stays for rare drug reaction
NCT ID NCT06734884
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether adding benralizumab (a drug already used for asthma) to standard corticosteroid treatment can help people with DRESS syndrome recover faster and spend fewer days in the hospital. DRESS is a rare, severe allergic reaction to certain medications that can damage multiple organs. The study will enroll 96 adults and compare benralizumab injections to a placebo, given alongside usual care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Benralizumab (Fasenra)
- What this could lead to
- If it works, this could provide a faster recovery from DRESS syndrome and reduce the time patients need to spend in the hospital.
- What could go wrong
- This is an early Phase 2 trial with only 96 participants, so results may not apply to everyone. Benralizumab also has known side effects, and the added benefit over standard care is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients (minimum 18year-old) 2. diagnosed at D0 (= baseline and inclusion) with DRESS defined by: 1. 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 2. 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) 3. AND Fever ≥ 38°C at the time of the examination or notion of a thermal peak ≥ 38°C in the preceding 72 hours. 4. 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 : * 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). 3. With eosinophilia (blood eosinophil count ≥ 500/mm3 or ≥0.5 G/L). 4. Patient having given written informed consent 5. patient with social insurance Exclusion Criteria: 1. Patients \<18 year-old 2. Patients with DRESS with REGIScar score \<4 3. Patients without skin eruption at baseline 4. Eosinophils blood count \<500/mm3 or \< 0.5 G/L at baseline 5. Patients with contra-indication to blood samples dedicated to the biocollection, according to the investigator's opinion 6. Patients with contra-indication to stop the culprit drug(s) involved in DRESS 7. Past history of hypersensitivity to biological drugs 8. Patients who received a previous anti-IL5 or anti-IL5 receptor therapy within 5 half lives (= 4 months) before inclusion 9. Patients with a contra-indication of topical corticosteroids (mainly a past history of contact eczema with clobetasol propionate) 10. Pregnancy and lactation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Delphine STAUMONT-SALLE
Lille, Nord, 59000, France
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