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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05334368




Registration number
NCT05334368
Ethics application status
Date submitted
12/04/2022
Date registered
19/04/2022
Date last updated
26/11/2024

Titles & IDs
Public title
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)
Secondary ID [1] 0 0
217013
Universal Trial Number (UTN)
Trial acronym
DESTINY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypereosinophilic Syndrome 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Depemokimab
Other interventions - Placebo

Experimental: Depemokimab - All participants in this arm will receive depemokimab.

Placebo comparator: Placebo - All participants in this arm will receive placebo.


Treatment: Drugs: Depemokimab
Depemokimab will be administered.

Other interventions: Placebo
Matching placebo will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of HES flares
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
Time to first HES flare
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [2] 0 0
Number of participants with at least one HES flare during the 52-week study intervention period
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [3] 0 0
Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours)
Timepoint [3] 0 0
Baseline and up to Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/03/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Georgia
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Utah
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Argentina
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Buenos Aires
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Argentina
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Florida
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Argentina
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La Plata
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Argentina
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Mar del Plata
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Argentina
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Quilmes
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Belgium
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Bruxelles
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Brazil
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Blumenau
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sorocaba
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Canada
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Ontario
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China
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Beijing
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China
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Changsha
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China
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Guangzhou
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China
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Harbin
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China
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Nanchang
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China
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Shanghai
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China
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Suzhou
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China
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Wuhan
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Czechia
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Brno - Bohunice
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Czechia
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Hradec Kralove
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Czechia
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Praha 4
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Czechia
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Usti nad Labem
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Denmark
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Odense C
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Germany
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Bad Bramstedt
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Germany
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Mannheim
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Greece
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Athens
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Greece
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Rio Patras
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Hong Kong
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Pokfulam
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Bologna
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Italy
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Catania
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Italy
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Milano
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Italy
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Napoli
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Italy
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Novara
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Italy
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Pavia
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Italy
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Roma
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Italy
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Treviso
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Italy
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Verona
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Gifu
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Tokyo
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Japan
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Yamanashi
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Kangwondo
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon Kyunggi-do
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Veracruz
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Poland
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Lodz
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Romania
State/province [67] 0 0
Bucharest
Country [68] 0 0
Romania
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Cluj-Napoca
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
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Granada
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Spain
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Madrid
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Spain
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Pozuelo De AlarcOn Madr
Country [73] 0 0
Spain
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Salamanca
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Spain
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Valencia
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Spain
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Zaragoza
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05334368
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05334368