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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05334368
Other study ID # 217013
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 6, 2022
Est. completion date March 26, 2026

Study information

Verified date September 2023
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 26, 2026
Est. primary completion date February 26, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-PDGFRa 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Depemokimab
Depemokimab will be administered.
Other:
Placebo
Matching placebo will be administered.

Locations

Country Name City State
Argentina GSK Investigational Site Caba Buenos Aires
Argentina GSK Investigational Site Florida Buenos Aires
Argentina GSK Investigational Site La Plata Buenos Aires
Argentina GSK Investigational Site Mar del Plata Buenos Aires
Argentina GSK Investigational Site Quilmes Buenos Aires
Australia GSK Investigational Site Canberra Australian Capital Territory
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Leuven
Brazil GSK Investigational Site Blumenau Santa Catarina
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Sorocaba São Paulo
China GSK Investigational Site Beijing
China GSK Investigational Site Changsha Hunan
China GSK Investigational Site Guangzhou Guangdong
China GSK Investigational Site Guangzhou Guangdong
China GSK Investigational Site Harbin Heilongjiang
China GSK Investigational Site Nanchang Jiangxi
China GSK Investigational Site Shanghai
China GSK Investigational Site Suzhou Jiangsu
China GSK Investigational Site Wuhan Hubei
Czechia GSK Investigational Site Brno
Czechia GSK Investigational Site Hradec Kralove
Czechia GSK Investigational Site Praha
Czechia GSK Investigational Site Usti nad Labem
Denmark GSK Investigational Site Odense
Germany GSK Investigational Site Bad Bramstedt Schleswig-Holstein
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Patras
Greece GSK Investigational Site Patras,Achaia
Hong Kong GSK Investigational Site Hong Kong
Hong Kong GSK Investigational Site Shatin
Israel GSK Investigational Site Ramat-Gan
Israel GSK Investigational Site Tel Aviv
Italy GSK Investigational Site Bologna Emilia-Romagna
Italy GSK Investigational Site Catania Sicilia
Italy GSK Investigational Site Milan Lombardia
Italy GSK Investigational Site Napoli Campania
Italy GSK Investigational Site Novara Piemonte
Italy GSK Investigational Site Pavia Lombardia
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Torino
Italy GSK Investigational Site Treviso Veneto
Italy GSK Investigational Site Verona Veneto
Japan GSK Investigational Site Aomori
Japan GSK Investigational Site Aomori
Japan GSK Investigational Site Chiba
Japan GSK Investigational Site Gifu
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Miyagi
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Yamanashi
Korea, Republic of GSK Investigational Site Chonju
Korea, Republic of GSK Investigational Site Gangwon-do
Korea, Republic of GSK Investigational Site Gwangju
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Suwon-si, Gyeonggi-do
Mexico GSK Investigational Site Guadalajara Jalisco
Mexico GSK Investigational Site Monterrey Nuevo León
Mexico GSK Investigational Site Veracruz
Poland GSK Investigational Site Lodz
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Cluj-Napoca
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Granada
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Pozuelo (Madrid)
Spain GSK Investigational Site Salamanca
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Zaragoza
Turkey GSK Investigational Site Ankara
Turkey GSK Investigational Site Izmir
United Kingdom GSK Investigational Site Leicester
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site La Jolla California
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site Rochester Minnesota
United States GSK Investigational Site Southfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  China,  Czechia,  Denmark,  Germany,  Greece,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of HES flares 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.
Up to 52 weeks
Secondary Time to first HES flare The time to first HES flare will be calculated from the date of first dose of study intervention and the start date of the HES flare. Time to the first HES flare will be assessed and reported in days. Up to 52 weeks
Secondary Number of participants with at least one HES flare during the 52-week study intervention period Up to 52 weeks
Secondary Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours) The BFI is a tool developed for the rapid assessment of fatigue severity for use in both clinical Screening and clinical trials. The BFI has 9 items. The participant should rate their average and worst fatigue levels over the previous 24 hours using a numeric rating scale anchored with 0 (no fatigue/interference) and 10 (as bad as you can imagine/completely interferes) numeric rating scales Baseline and up to Week 52
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