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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

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 - Canberra
Recruitment postcode(s) [1] 0 0
2606 - Canberra
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
State/province [2] 0 0
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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Michigan
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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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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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Argentina
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Buenos Aires
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Belgium
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Bruxelles
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Belgium
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Leuven
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Canada
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Ontario
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China
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Guangdong
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China
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Heilongjiang
Country [19] 0 0
China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Beijing
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China
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Shanghai
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha
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Czechia
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Usti nad Labem
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Denmark
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Odense
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Germany
State/province [30] 0 0
Baden-Wuerttemberg
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Germany
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Schleswig-Holstein
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
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Greece
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Patras
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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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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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Sicilia
Country [44] 0 0
Italy
State/province [44] 0 0
Veneto
Country [45] 0 0
Japan
State/province [45] 0 0
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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Chonju
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si, Gyeonggi-do
Country [58] 0 0
Mexico
State/province [58] 0 0
Jalisco
Country [59] 0 0
Mexico
State/province [59] 0 0
Nuevo León
Country [60] 0 0
Mexico
State/province [60] 0 0
Veracruz
Country [61] 0 0
Poland
State/province [61] 0 0
Lodz
Country [62] 0 0
Romania
State/province [62] 0 0
Bucharest
Country [63] 0 0
Romania
State/province [63] 0 0
Cluj-Napoca
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
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Spain
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Granada
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Spain
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Madrid
Country [67] 0 0
Spain
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Pozuelo (Madrid)
Country [68] 0 0
Spain
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Salamanca
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Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Spain
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Zaragoza
Country [71] 0 0
Turkey
State/province [71] 0 0
Ankara
Country [72] 0 0
Turkey
State/province [72] 0 0
Izmir
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Leicester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05334368