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

Hypereosinophilic Syndrome Clinical Trial

— DESTINY  

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334368
• Other study ID #: 217013
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Hypereosinophilic Syndrome
• Syndrome

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

External Links

•   Related Info