Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aims to tame rare blood disorder flares

NCT ID NCT05334368

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests a drug called depemokimab in adults with hypereosinophilic syndrome (HES), a rare condition where too many eosinophils (a type of white blood cell) cause organ damage. The trial includes 123 people whose HES is not well controlled despite standard therapy. Participants receive either depemokimab or a placebo for 52 weeks, and researchers track how many disease flares occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
depemokimab
What this could lead to
If successful, depemokimab could offer a new option to help control HES and reduce the number of disease flares.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not reduce flares more than placebo, and side effects are possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 109 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who are greater than or equal (\>=) 40 kilogram (kg) at Screening Visit 1. * Participants who have a documented diagnosis of HES prior to Visit 2. * A history of 2 or more HES flares within the past 12 months prior to Visit 1. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percentage (%). * Capable of giving signed informed consent. Exclusion Criteria: * Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data. * Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1. * Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus \[HIV\]), other than that explained by the use of OCS or other therapy taken for HES. * Participants with a history of or current lymphoma. * Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded. * Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified. * Cirrhosis or current unstable liver or biliary disease per investigator assessment. * Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. * Participants with current diagnosis of vasculitis. * Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction. * Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA). * Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product. * Participants who have a previous documented failure with anti-interleukin (IL)-5/5R therapy. * Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1. * Participants who test positive for the FIP1L1-PDGFRα fusion gene. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1. * Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator. * Participants who are pregnant or breastfeeding.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypereosinophilic syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hypereosinophilic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypereosinophilic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    85 sites in 20 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • GSK Investigational Site

    RECRUITING

    San Diego, California, 920237, United States

  • GSK Investigational Site

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • GSK Investigational Site

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • GSK Investigational Site

    WITHDRAWN

    Southfield, Michigan, 48075, United States

  • GSK Investigational Site

    WITHDRAWN

    Rochester, Minnesota, 55905, United States

  • GSK Investigational Site

    COMPLETED

    Manhasset, New York, 11030, United States

  • GSK Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • GSK Investigational Site

    RECRUITING

    Columbus, Ohio, 43212, United States

  • GSK Investigational Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • GSK Investigational Site

    COMPLETED

    Nashville, Tennessee, 37208, United States

  • GSK Investigational Site

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1425BEN, Argentina

  • GSK Investigational Site

    RECRUITING

    Florida, 1602, Argentina

  • GSK Investigational Site

    RECRUITING

    La Plata, B1900, Argentina

  • GSK Investigational Site

    RECRUITING

    Mar del Plata, 7600, Argentina

  • GSK Investigational Site

    RECRUITING

    Quilmes, 1878, Argentina

  • GSK Investigational Site

    COMPLETED

    Garran, Australian Capital Territory, 2606, Australia

  • GSK Investigational Site

    RECRUITING

    Brussels, 1070, Belgium

  • GSK Investigational Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • GSK Investigational Site

    RECRUITING

    Blumenau, 89030-101, Brazil

  • GSK Investigational Site

    RECRUITING

    Rio de Janeiro, 21.941-913, Brazil

  • GSK Investigational Site

    RECRUITING

    Sorocaba, 18040-425, Brazil

  • GSK Investigational Site

    RECRUITING

    Ottawa, Ontario, K1H 1E4, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • GSK Investigational Site

    RECRUITING

    Beijing, 100730, China

  • GSK Investigational Site

    RECRUITING

    Changsha, 410008, China

  • GSK Investigational Site

    RECRUITING

    Guangzhou, 510080, China

  • GSK Investigational Site

    RECRUITING

    Guangzhou, 510163, China

  • GSK Investigational Site

    RECRUITING

    Guangzhou, 510515, China

  • GSK Investigational Site

    RECRUITING

    Harbin, 150010, China

  • GSK Investigational Site

    RECRUITING

    Nanchang, 330006, China

  • GSK Investigational Site

    RECRUITING

    Shanghai, 200025, China

  • GSK Investigational Site

    RECRUITING

    Suzhou, 215006, China

  • GSK Investigational Site

    RECRUITING

    Wuhan, 430022, China

  • GSK Investigational Site

    RECRUITING

    Brno-Bohunice, 625 00, Czechia

  • GSK Investigational Site

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • GSK Investigational Site

    RECRUITING

    Prague, 14059, Czechia

  • GSK Investigational Site

    RECRUITING

    Ústí nad Labem, 40113, Czechia

  • GSK Investigational Site

    RECRUITING

    Odense C, 5000, Denmark

  • GSK Investigational Site

    RECRUITING

    Bad Bramstedt, 24576, Germany

  • GSK Investigational Site

    RECRUITING

    Mannheim, 68167, Germany

  • GSK Investigational Site

    RECRUITING

    Athens, 10676, Greece

  • GSK Investigational Site

    WITHDRAWN

    Rio Patras, 26054, Greece

  • GSK Investigational Site

    RECRUITING

    Pokfulam, Hong Kong

  • GSK Investigational Site

    RECRUITING

    Ramat Gan, 52621, Israel

  • GSK Investigational Site

    WITHDRAWN

    Tel Aviv, 64239, Israel

  • GSK Investigational Site

    RECRUITING

    Bologna, 40138, Italy

  • GSK Investigational Site

    RECRUITING

    Catania, 95123, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20132, Italy

  • GSK Investigational Site

    RECRUITING

    Naples, 80131, Italy

  • GSK Investigational Site

    RECRUITING

    Novara, 28100, Italy

  • GSK Investigational Site

    RECRUITING

    Pavia, 27100, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00168, Italy

  • GSK Investigational Site

    RECRUITING

    Treviso, 31100, Italy

  • GSK Investigational Site

    RECRUITING

    Verona, 37134, Italy

  • GSK Investigational Site

    RECRUITING

    Aomori, 030-8553, Japan

  • GSK Investigational Site

    RECRUITING

    Aomori, 036-8563, Japan

  • GSK Investigational Site

    RECRUITING

    Chiba, 272-8516, Japan

  • GSK Investigational Site

    RECRUITING

    Gifu, 509-6134, Japan

  • GSK Investigational Site

    RECRUITING

    Hyōgo, 670-8540, Japan

  • GSK Investigational Site

    RECRUITING

    Kanagawa, 259-1143, Japan

  • GSK Investigational Site

    RECRUITING

    Miyagi, 980-8574, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 105-8471, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 142-8666, Japan

  • GSK Investigational Site

    RECRUITING

    Wakayama, 641-8509, Japan

  • GSK Investigational Site

    RECRUITING

    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

    RECRUITING

    Guadalajara, 44130, Mexico

  • GSK Investigational Site

    RECRUITING

    Monterrey, 64060, Mexico

  • GSK Investigational Site

    RECRUITING

    Veracruz, 94534, Mexico

  • GSK Investigational Site

    RECRUITING

    Chęciny, 26-060, Poland

  • GSK Investigational Site

    RECRUITING

    Lodz, 90-153, Poland

  • GSK Investigational Site

    RECRUITING

    Bucharest, 020125, Romania

  • GSK Investigational Site

    RECRUITING

    Bucharest, 31281, Romania

  • GSK Investigational Site

    RECRUITING

    Cluj-Napoca, 400124, Romania

  • GSK Investigational Site

    RECRUITING

    Gwangju, 61469, South Korea

  • GSK Investigational Site

    RECRUITING

    Jeonju, 561-712, South Korea

  • GSK Investigational Site

    RECRUITING

    Kangwondo, 26426, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06351, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06591, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 110-744, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 136-705, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 138-736, South Korea

  • GSK Investigational Site

    RECRUITING

    Suwon Kyunggi-do, 16499, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08036, Spain

  • GSK Investigational Site

    RECRUITING

    Granada, 18014, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28008, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28031, Spain

  • GSK Investigational Site

    RECRUITING

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    RECRUITING

    Salamanca, 37007, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46026, Spain

  • GSK Investigational Site

    RECRUITING

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    RECRUITING

    Leicester, Leicestershire, LE3 9QP, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.