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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
19/09/2024

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
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Belgium
State/province [10] 0 0
Bruxelles
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio Grande Do Sul
Country [13] 0 0
Brazil
State/province [13] 0 0
Santa Catarina
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio de Janeiro
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Canada
State/province [16] 0 0
Ontario
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China
State/province [17] 0 0
Guangdong
Country [18] 0 0
China
State/province [18] 0 0
Heilongjiang
Country [19] 0 0
China
State/province [19] 0 0
Hubei
Country [20] 0 0
China
State/province [20] 0 0
Hunan
Country [21] 0 0
China
State/province [21] 0 0
Jiangsu
Country [22] 0 0
China
State/province [22] 0 0
Jiangxi
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
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Czechia
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Hradec Kralove
Country [27] 0 0
Czechia
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Praha
Country [28] 0 0
Czechia
State/province [28] 0 0
Usti nad Labem
Country [29] 0 0
Denmark
State/province [29] 0 0
Odense
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Wuerttemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Schleswig-Holstein
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
Country [33] 0 0
Greece
State/province [33] 0 0
Patras
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Hong Kong
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Shatin
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat-Gan
Country [37] 0 0
Israel
State/province [37] 0 0
Tel Aviv
Country [38] 0 0
Italy
State/province [38] 0 0
Campania
Country [39] 0 0
Italy
State/province [39] 0 0
Emilia-Romagna
Country [40] 0 0
Italy
State/province [40] 0 0
Lazio
Country [41] 0 0
Italy
State/province [41] 0 0
Lombardia
Country [42] 0 0
Italy
State/province [42] 0 0
Piemonte
Country [43] 0 0
Italy
State/province [43] 0 0
Sicilia
Country [44] 0 0
Italy
State/province [44] 0 0
Veneto
Country [45] 0 0
Japan
State/province [45] 0 0
Aomori
Country [46] 0 0
Japan
State/province [46] 0 0
Chiba
Country [47] 0 0
Japan
State/province [47] 0 0
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
State/province [56] 0 0
Seoul
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Korea, Republic of
State/province [57] 0 0
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
Country [65] 0 0
Spain
State/province [65] 0 0
Granada
Country [66] 0 0
Spain
State/province [66] 0 0
Madrid
Country [67] 0 0
Spain
State/province [67] 0 0
Pozuelo (Madrid)
Country [68] 0 0
Spain
State/province [68] 0 0
Salamanca
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Spain
State/province [70] 0 0
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
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
Contact person for scientific queries



Summary Results

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