A Study of Depemokimab and Prednisolone in Adults with Hypereosinophilic Syndrome (HES)

1 1 1

What is this study about?

This study focuses on people with Hypereosinophilic Syndrome (HES), a rare blood condition where there are too many white blood cells called eosinophils in the blood and tissues. These elevated levels can cause damage to various organs in the body. The study will test a new medication called depemokimab, which is given as an injection under the skin, along with standard treatments that may include prednisolone tablets.

The purpose of this research is to determine if depemokimab is effective in controlling HES when compared to placebo in people who are already receiving standard care. The study will last for 52 weeks, during which participants will receive either depemokimab injections or placebo injections. Some participants will also receive prednisolone tablets or matching placebo tablets as part of their treatment.

Throughout the study, doctors will monitor how often participants experience HES flares, which are periods when symptoms get worse or blood eosinophil counts increase. The medication will be provided in a pre-filled syringe for injection under the skin. Participants will be regularly checked for any changes in their condition and any effects of the treatment.

1 Initial treatment phase

You will receive either depemokimab (study medication) or a placebo (substance with no active medication) through subcutaneous injection (under the skin).

You will continue your standard care medications during the study.

The treatment phase lasts for 52 weeks (one year).

2 Monitoring period

Your health condition will be monitored throughout the 52-week period.

The medical team will track any episodes of HES flares (worsening of your condition).

You will complete the Brief Fatigue Inventory questionnaire to assess your fatigue levels.

3 Regular assessments

Your blood will be tested to measure eosinophil levels (type of white blood cells).

The medical team will evaluate any symptoms or changes in your condition.

Your fatigue levels will be measured regularly using a specific questionnaire.

4 Study completion

The study ends after 52 weeks of treatment.

Final assessments will be conducted to evaluate your response to the treatment.

Your eosinophil levels and overall health condition will be evaluated one last time.

Who Can Join the Study?

  • Must be at least 18 years old when signing the consent form
  • Must weigh at least 40 kilograms (88 pounds) at screening
  • Must have a confirmed diagnosis of Hypereosinophilic Syndrome (HES) with:
    • Blood tests showing more than 1,500 eosinophils (a type of white blood cell) per microliter at least twice, with tests done at least 1 month apart
    • Signs of organ problems related to high eosinophil levels
  • Must have experienced at least 2 HES flares in the past 12 months, where:
    • A flare means worsening of symptoms or increased eosinophil counts requiring stronger treatment
    • At least one flare must not be related to reducing medication in the previous 4 weeks
  • Can be male or female, but females must either be:
    • Unable to bear children, or
    • Using highly effective birth control (99% or better) from 14 days before starting the study until 30 weeks after the last dose
  • Must not be pregnant or breastfeeding
  • Must be able to understand and sign the informed consent form

Who Cannot Join the Study?

  • Current diagnosis of parasitic infection (an infection caused by parasites)
  • History of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Current active infection requiring treatment with antibiotics, antivirals, or antifungals
  • History of severe allergic reactions to biological medications
  • Pregnant women or women planning to become pregnant during the study period
  • Breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • Significant heart conditions including heart failure or recent heart attack
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Unable to follow study procedures or attend scheduled visits
  • Use of prohibited medications that might interfere with the study drug

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Klinikum Bad Bramstedt GmbH Bad Bramstedt Germany
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Hospital Unviersitario Miguel Servet Zaragoza Spain
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Odense University Hospital Odense Denmark
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Krajska zdravotni a.s. Teplice Czechia
Fakultni Thomayerova nemocnice Prague Czechia
San Raffaele Scientific Institute Milan Italy
Hgxohriq Utchdcjwaacsz Hmn Mhzrgjp Madrid Spain
Wnekuiqthj Slgsbyp Sboz imz shl Rnvfpt w Czjpdeyeb Gfopl Skhdtaguilizro Ckjjxin Cspspo Pstq Checiny Poland
Akmtucr Ulyrf Skwdkhcvh Lvbdpx De Bhsujks Bologna Italy
Eacunhrtbnrnkxknulwubkzbws Hcbbctyf oc Axmwrt Athens Greece

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.11.2022
Czechia Czechia
Recruiting
22.11.2022
Denmark Denmark
Recruiting
22.11.2022
Germany Germany
Recruiting
22.11.2022
Greece Greece
Recruiting
22.11.2022
Italy Italy
Recruiting
22.11.2022
Poland Poland
Recruiting
22.11.2022
Romania Romania
Recruiting
22.11.2022
Spain Spain
Recruiting
22.11.2022

Trial locations

Investigated drugs:

Depemokimab is an investigational medication given by injection under the skin (subcutaneous injection). It is being studied for treating people with Hypereosinophilic Syndrome (HES), a rare blood disorder where the body produces too many eosinophils (a type of white blood cell). This medication aims to help control the condition in patients who are not responding well enough to standard treatments.

Standard of Care (SoC) refers to the current best available treatments that patients typically receive for managing their Hypereosinophilic Syndrome. These treatments will continue to be used alongside the study medication.

Investigated diseases:

Hypereosinophilic Syndrome (HES) – A rare blood disorder characterized by a persistent increase in eosinophils (a type of white blood cell) in the blood and tissues. The elevated levels of eosinophils can cause inflammation and damage to multiple organs, including the heart, skin, lungs, and nervous system. The condition typically develops gradually and can affect people of any age. Symptoms may include fatigue, fever, cough, muscle pain, rashes, and breathing difficulties. The severity and progression of symptoms can vary significantly among individuals.

Trial ID:
2023-510346-25-00
Protocol code:
217013
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Access to Mepolizumab for Patients with Hypereosinophilic Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland
  • Study on Mepolizumab for Children and Teens with Hypereosinophilic Syndrome

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Spain