Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Last updated: April 21, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Depemokimab

Placebo

Clinical Study ID

NCT05334368
217013
  • Ages > 18
  • All Genders

Study Summary

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy.

The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy.

Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who are greater than or equal (>=) 40 kilogram (kg) at Screening Visit
  • 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 orbreastfeeding, and one of the following conditions applies: a) woman ofnon-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP)and using a contraceptive method that is highly effective, with a failure rate ofless than (<) 1 percentage (%).

  • Capable of giving signed informed consent.

Exclusion

Exclusion Criteria:

  • Participants with HES disease manifestations which in the opinion of theinvestigator may put the participant at unacceptable risk from study participationor confound interpretation of efficacy or safety data.

  • Participants with chronic or ongoing active infections requiring systemic treatmentor 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 forless 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 beexcluded.

  • Participants with a haematologic malignancy with hypereosinophilia in which HES isnot the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplasticsyndrome, 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 diseaseuncontrolled 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, orany of the excipients of the investigational product.

  • Participants who have a previous documented failure with anti-interleukin (IL)-5/5Rtherapy.

  • Participants who have received monoclonal antibodies (mAb) within 30 days or 5half-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) ≥450milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block atScreening Visit 1.

  • Participants who are not responsive to OCS based on clinical response or bloodeosinophil counts in the opinion of the Investigator.

  • Participants who are pregnant or breastfeeding.

Study Design

Total Participants: 123
Treatment Group(s): 2
Primary Treatment: Depemokimab
Phase: 3
Study Start date:
September 06, 2022
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • GSK Investigational Site

    Caba, Buenos Aires C1425BEN
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1425BEN
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florida, 1602
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    La Plata, B1900
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mar del Plata, 7600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Quilmes, 1878
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Canberra, Australian Capital Territory 2606
    Australia

    Site Not Available

  • GSK Investigational Site

    Garran, Australian Capital Territory 2606
    Australia

    Completed

  • GSK Investigational Site

    Bruxelles, 1070
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Blumenau, 89030-101
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Rio de Janeiro, 21.941-913
    Brazil

    Site Not Available

  • GSK Investigational Site

    Sorocaba, 18040-425
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • GSK Investigational Site

    Beijing, 100730
    China

    Active - Recruiting

  • GSK Investigational Site

    Changsha, 410008
    China

    Active - Recruiting

  • GSK Investigational Site

    Guangzhou, 510515
    China

    Active - Recruiting

  • GSK Investigational Site

    Harbin, 150010
    China

    Active - Recruiting

  • GSK Investigational Site

    Nanchang, 330006
    China

    Active - Recruiting

  • GSK Investigational Site

    Shanghai, 200025
    China

    Active - Recruiting

  • GSK Investigational Site

    Suzhou, 215006
    China

    Active - Recruiting

  • GSK Investigational Site

    Wuhan, 430022
    China

    Active - Recruiting

  • GSK Investigational Site

    Brno, 625 00
    Czechia

    Site Not Available

  • GSK Investigational Site

    Brno - Bohunice, 625 00
    Czechia

    Active - Recruiting

  • GSK Investigational Site

    Hradec Kralove, 500 05
    Czechia

    Active - Recruiting

  • GSK Investigational Site

    Praha, 14059
    Czechia

    Site Not Available

  • GSK Investigational Site

    Praha 4, 14059
    Czechia

    Active - Recruiting

  • GSK Investigational Site

    Usti nad Labem, 40113
    Czechia

    Site Not Available

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    Odense, 5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense C, 5000
    Denmark

    Active - Recruiting

  • GSK Investigational Site

    Bad Bramstedt, 24576
    Germany

    Site Not Available

  • GSK Investigational Site

    Mannheim, 68167
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Athens, 10676
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Patras, 26054
    Greece

    Site Not Available

  • GSK Investigational Site

    Patras,Achaia, 26504
    Greece

    Site Not Available

  • GSK Investigational Site

    Rio Patras, 26054
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Hong Kong,
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Pokfulam,
    Hong Kong

    Active - Recruiting

  • GSK Investigational Site

    Shatin,
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Ramat Gan, 52621
    Israel

    Active - Recruiting

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    Ramat-Gan, 52621
    Israel

    Site Not Available

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    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • GSK Investigational Site

    Milan, Lombardia 20132
    Italy

    Site Not Available

  • GSK Investigational Site

    Bologna, 40138
    Italy

    Site Not Available

  • GSK Investigational Site

    Catania, 95123
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milano, 20132
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Novara, 28100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Pavia, 27100
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, 00168
    Italy

    Active - Recruiting

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    Torino, 10154
    Italy

    Site Not Available

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    Treviso, 31100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Verona, 37134
    Italy

    Active - Recruiting

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    Aomori, 036-8563
    Japan

    Active - Recruiting

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    Chiba, 272-8516
    Japan

    Active - Recruiting

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    Gifu, 509-6134
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Hyogo, 670-8540
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kanagawa, 259-1143
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Miyagi, 980-8574
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tokyo, 142-8666
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Yamanashi, 409-3898
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Chonju, 561-712
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Gangwon-do, 26426
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Gwangju, 61469
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Jeonju, 561-712
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Kangwondo, 26426
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 110-744
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon Kyunggi-do, 16499
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon-si, Gyeonggi-do, 16499
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Guadalajara, 44130
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    Monterrey, 64060
    Mexico

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  • GSK Investigational Site

    Veracruz, 94534
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    Lodz, 90-153
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Bucharest, 31281
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Cluj-Napoca, 400124
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Active - Recruiting

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    Granada, 18014
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28031
    Spain

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  • GSK Investigational Site

    Pozuelo (Madrid), 28223
    Spain

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    Pozuelo De AlarcOn Madr, 28223
    Spain

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  • GSK Investigational Site

    Salamanca, 37007
    Spain

    Active - Recruiting

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    Valencia, 46026
    Spain

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  • GSK Investigational Site

    Zaragoza, 50009
    Spain

    Active - Recruiting

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    Ankara, 6600
    Turkey

    Site Not Available

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    Izmir, 35100
    Turkey

    Site Not Available

  • GSK Investigational Site

    Leicester, LE3 9QP
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    La Jolla, California 920237
    United States

    Site Not Available

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    San Diego, California 920237
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • GSK Investigational Site

    Boston, Massachusetts 02111
    United States

    Site Not Available

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    Southfield, Michigan 48075
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • GSK Investigational Site

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • GSK Investigational Site

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • GSK Investigational Site

    Columbus, Ohio 43212
    United States

    Site Not Available

  • GSK Investigational Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • GSK Investigational Site

    Nashville, Tennessee 37208
    United States

    Completed

  • GSK Investigational Site

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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