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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Frequency of HES flares — Up to 52 weeks A HES flare is defined as either: a HES-related clinical manifestation based on a physician documented change in clinical signs or symptoms resulting in the need for the following : An increase in the maintenance systemic corticosteroid dose by at least 10 mg/day (prednisone/prednisolone equivalent) for at least 5 days, and/or an increase in or addition of any cytotoxic and/or immunosuppressive HES therapy.
OR 2 or more courses of blinded active oral corticosteroid (OCS) during the intervention period. The frequency of HES flares will be calculated for each participant as the number of unique starting dates for HES flares.
Trial sites (93)
Facility
City
Region
Status
GSK Investigational Site
San Diego
California
Recruiting
GSK Investigational Site
Atlanta
Georgia
Completed
GSK Investigational Site
Boston
Massachusetts
Recruiting
GSK Investigational Site
Southfield
Michigan
Withdrawn
GSK Investigational Site
Rochester
Minnesota
Withdrawn
GSK Investigational Site
Manhasset
New York
Completed
GSK Investigational Site
Cincinnati
Ohio
Recruiting
GSK Investigational Site
Columbus
Ohio
Recruiting
GSK Investigational Site
Charleston
South Carolina
Recruiting
GSK Investigational Site
Nashville
Tennessee
Completed
GSK Investigational Site
Salt Lake City
Utah
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Florida
Argentina
Recruiting
GSK Investigational Site
La Plata
Argentina
Recruiting
GSK Investigational Site
Mar del Plata
Argentina
Recruiting
GSK Investigational Site
Quilmes
Argentina
Recruiting
GSK Investigational Site
Garran
Australian Capital Territory
Completed
GSK Investigational Site
Brussels
Belgium
Recruiting
GSK Investigational Site
Porto Alegre
Rio Grande do Sul
Recruiting
GSK Investigational Site
Blumenau
Brazil
Recruiting
GSK Investigational Site
Rio de Janeiro
Brazil
Recruiting
GSK Investigational Site
Sorocaba
Brazil
Recruiting
GSK Investigational Site
Ottawa
Ontario
Recruiting
GSK Investigational Site
Toronto
Ontario
Recruiting
GSK Investigational Site
Beijing
China
Recruiting
GSK Investigational Site
Changsha
China
Recruiting
GSK Investigational Site
Guangzhou
China
Recruiting
GSK Investigational Site
Guangzhou
China
Recruiting
GSK Investigational Site
Guangzhou
China
Recruiting
GSK Investigational Site
Harbin
China
Recruiting
GSK Investigational Site
Nanchang
China
Recruiting
GSK Investigational Site
Shanghai
China
Recruiting
GSK Investigational Site
Suzhou
China
Recruiting
GSK Investigational Site
Wuhan
China
Recruiting
GSK Investigational Site
Brno-Bohunice
Czechia
Recruiting
GSK Investigational Site
Hradec Králové
Czechia
Recruiting
GSK Investigational Site
Prague
Czechia
Recruiting
GSK Investigational Site
Ústí nad Labem
Czechia
Recruiting
GSK Investigational Site
Odense C
Denmark
Recruiting
GSK Investigational Site
Bad Bramstedt
Germany
Recruiting
+ 53 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.