Study of benralizumab compared to placebo for treatment of patients with Hypereosinophilic Syndrome (HES)

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What is this study about?

This study focuses on patients with Hypereosinophilic Syndrome (HES), a condition where there are persistently high levels of certain white blood cells called eosinophils in the blood, which can cause damage to various organs. The study will test a medication called benralizumab (Fasenra), which is given as an injection under the skin, to see if it can help control HES symptoms and prevent disease flares.

The research aims to determine how effective benralizumab is in delaying or preventing HES flares compared to placebo. During the study, which lasts 24 weeks, participants will receive either benralizumab or placebo through an injection under the skin using a pre-filled syringe. After this initial period, there is an opportunity to continue treatment in an open-label extension phase where all participants receive the active medication.

Throughout the study, doctors will monitor participants’ symptoms, particularly looking for signs of disease worsening or flares. They will also track changes in blood cell counts, fatigue levels, and overall health. The medication being tested is designed to reduce the number of eosinophils in the blood, which may help control the symptoms of HES and prevent organ damage.

1 Initial treatment period – double-blind phase

You will be randomly assigned to receive either benralizumab (30 mg) or placebo through subcutaneous injection

The treatment will continue for 24 weeks during this phase

Your condition will be monitored for signs of HES worsening (Hypereosinophilic Syndrome) or flares

2 Monitoring and assessments

Regular blood tests will be performed to measure your eosinophil count (a type of white blood cell)

Your fatigue levels will be assessed using a standardized questionnaire

Your overall health and quality of life will be evaluated using specific forms

Any symptoms or changes in your condition will be documented

3 Open-label extension period

After the initial 24-week period, you may continue treatment in the open-label extension phase

During this phase, all participants will receive benralizumab

Your condition will continue to be monitored for safety and effectiveness

Regular assessments of symptoms and laboratory tests will continue

4 Safety monitoring

Throughout the study, you will be monitored for any side effects

Regular checks of vital signs will be performed

Laboratory tests will be conducted to ensure your safety

Any changes in your health status will be documented and evaluated

Who Can Join the Study?

  • Must be at least 12 years old at the time of signing the consent form
  • Must provide signed and dated written informed consent (or have legal representative consent)
  • Must have a confirmed diagnosis of Hypereosinophilic Syndrome (HES) with:
    – Blood tests showing high levels of eosinophils (>1500 cells/μL) on two separate occasions at least 1 month apart
    – Evidence of organ problems caused by high eosinophil levels
  • Must test negative for a specific genetic mutation called FIP1L1-PDGFRA
  • Must be on stable HES treatment for at least 4 weeks before the first study visit
  • Must have either:
    – Current signs of HES getting worse, or
    – History of at least 2 HES flares in the past 12 months that required increased treatment
  • Must have an eosinophil count of at least 1000 cells/μL at first visit
  • Must respond to corticosteroid treatment (showing reduced eosinophil counts after taking prednisone/prednisolone)
  • For women who can become pregnant:
    – Must use effective birth control during the study and for 12 weeks after
    – Must have a negative pregnancy test at first visit
  • For women who cannot become pregnant, must either:
    – Have had specific surgical procedures (hysterectomy or removal of ovaries/fallopian tubes), or
    – Be post-menopausal (no menstrual periods for at least 12 months)

Who Cannot Join the Study?

  • Age under 12 years old
  • Known allergic reactions to benralizumab or similar medications
  • Pregnancy or breastfeeding
  • Active or untreated parasitic infections (infections caused by parasites)
  • Participation in other clinical trials within the last 30 days
  • Severe liver disease (problems with liver function)
  • Severe kidney disease (problems with kidney function)
  • Active cancer or ongoing cancer treatment
  • Uncontrolled heart conditions
  • History of severe allergic reactions
  • Recent major surgery (within last 3 months)
  • Active infections requiring antibiotics
  • Use of other biological treatments for HES (Hypereosinophilic Syndrome) in the past 4 months
  • Mental conditions that could interfere with following study procedures
  • Drug or alcohol abuse within the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Hospital Foch Suresnes France
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nice Nice France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Rigshospitalet Copenhagen Denmark
Hsipkzte Upzhboambenrq Mbsfwjq Dt Vpuqtgwekh Santander Spain
Wuriqmcygo Swfwldv Svco imk smo Rcasna w Cdlnasrre Gxixr Stzndrwejcglbe Ckykxkq Cvcqty Pqcj Checiny Poland
Eqdoeba Uabftskzpbde Mjyvcgs Caqqifj Rrjiopsnv (kigwlmh Mxe Rotterdam The Netherlands
Aqeyyss Usziy Suqepkeqe Lndhkm Dn Bfztbrb Bologna Italy
Uxiutredmazgaa Cpdmlcj Kflmcvlcq Gdansk Poland
Uokliexafd Ok Adptoqd Edegem Belgium
Htcibygs Ugbtfpzmmusobt Sreziyowxa &fuhotx Hvxquuo dx Hqudpbqpwgr STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
07.09.2020
Belgium Belgium
Not recruiting
07.09.2020
Denmark Denmark
Not recruiting
07.09.2020
France France
Not recruiting
07.09.2020
Germany Germany
Not recruiting
07.09.2020
Italy Italy
Not recruiting
07.09.2020
Poland Poland
Not recruiting
07.09.2020
Spain Spain
Not recruiting
07.09.2020
The Netherlands The Netherlands
Not recruiting
07.09.2020

Trial locations

Investigated drugs:

Benralizumab is a medication used to treat patients with Hypereosinophilic Syndrome (HES), a rare blood disorder. It works by targeting and reducing specific white blood cells called eosinophils that are present in unusually high numbers in HES patients. This medication is designed to help prevent disease flares and worsening of symptoms in people with HES. It is administered through injections.

Investigated diseases:

Hypereosinophilic Syndrome (HES) – A blood disorder characterized by persistently elevated levels of eosinophils (a type of white blood cell) in the blood and tissues. The condition occurs when the body produces too many eosinophils without a known cause. These elevated eosinophils can gradually cause damage to various organs, including the heart, lungs, skin, and nervous system. Patients may experience different symptoms depending on which organs are affected, such as fatigue, skin rashes, breathing difficulties, or numbness in limbs. The severity of symptoms can vary greatly among individuals, and the condition can progress at different rates.

Trial ID:
2023-510455-28-00
Protocol code:
D3254C00001
NCT ID:
NCT04191304
Trial Phase:
Therapeutic confirmatory (Phase III)

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