Hypereosinophilic SyndromePhase 3DESTINYNCT05334368
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
A Phase 3 study testing Depemokimab in people with Hypereosinophilic Syndrome, run by GlaxoSmithKline at 60 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypereosinophilic Syndrome
- What is being tested?
- Depemokimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 60 sitesin 16 countries
- Study dates
- 6 Sep 2022to 29 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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-PDGFRα 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.
Trial locations and contacts
60 sites in 16 countries.
60 sites in 16 countries
Japan9 sites
GSK Investigational Site
Aomori, 030-8553
GSK Investigational Site
Chiba, 272-8516
GSK Investigational Site
Gifu, 509-6134
GSK Investigational Site
Hyōgo, 670-8540
GSK Investigational Site
Miyagi, 980-8574
GSK Investigational Site
Tokyo, 105-8471
GSK Investigational Site
Tokyo, 142-8666
GSK Investigational Site
Wakayama, 641-8509
GSK Investigational Site
Yamanashi, 409-3898
South Korea9 sites
GSK Investigational Site
Gwangju, 61469
GSK Investigational Site
Jeonju, 561-712
GSK Investigational Site
Kangwondo, 26426
GSK Investigational Site
Seoul, 06351
GSK Investigational Site
Seoul, 06591
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 136-705
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Suwon Kyunggi-do, 16499
China8 sites
GSK Investigational Site
Beijing, 100730
GSK Investigational Site
Changsha, 410008
GSK Investigational Site
Guangzhou, 510080
GSK Investigational Site
Guangzhou, 510515
GSK Investigational Site
Nanchang, 330006
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Suzhou, 215006
GSK Investigational Site
Wuhan, 430022
United States5 sites
GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Columbus, Ohio, 43212
GSK Investigational Site
Manhasset, New York, 11030
GSK Investigational Site
Nashville, Tennessee, 37208
GSK Investigational Site
San Diego, California, 92192
Argentina5 sites
GSK Investigational Site
Buenos Aires, C1425BEN
GSK Investigational Site
Florida, 1602
GSK Investigational Site
La Plata, B1900
GSK Investigational Site
Mar del Plata, 7600
GSK Investigational Site
Quilmes, 1878
Brazil4 sites
GSK Investigational Site
Blumenau, 89030-101
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
GSK Investigational Site
Rio de Janeiro, 21.941-913
GSK Investigational Site
Sorocaba, 18040-350
Italy3 sites
GSK Investigational Site
Catania, 95123
GSK Investigational Site
Novara, 28100
GSK Investigational Site
Roma, 00168
Mexico3 sites
GSK Investigational Site
Guadalajara, 44130
GSK Investigational Site
Monterrey, 64060
GSK Investigational Site
Veracruz, 94534
Romania3 sites
GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Bucharest, 31281
GSK Investigational Site
Cluj-Napoca, 400124
Canada2 sites
GSK Investigational Site
Ottawa, Ontario, K1H 1E4
GSK Investigational Site
Toronto, Ontario, M5G 1X5
Czechia2 sites
GSK Investigational Site
Brno-Bohunice, 625 00
GSK Investigational Site
Prague, 14059
Poland2 sites
GSK Investigational Site
Chęciny, 26-060
GSK Investigational Site
Lodz, 90-153
Spain2 sites
GSK Investigational Site
Madrid, 28031
GSK Investigational Site
Valencia, 46026
Australia1 site
GSK Investigational Site
Garran, Australian Capital Territory, 2606
United Kingdom1 site
GSK Investigational Site
Leicester, Leicestershire, LE3 9QP
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)
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.
- Conditions
- Hypereosinophilic Syndrome
- Being tested
- Depemokimab, Placebo
- Keywords
- Depemokimab, Hypereosinophilic Syndrome, DESTINY, Monoclonal antibody, Anti-interleukin -5
- Medical subject headings
- Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepemokimabDrug
Depemokimab will be administered.
PlaceboOther
Matching placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Depemokimab | Experimental | All participants in this arm will receive depemokimab. Receives: Drug: Depemokimab |
| Placebo | Placebo comparator | All participants in this arm will receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 52 weeks
Secondary outcomes (3)
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.
Measured: Up to 52 weeks
Number of participants with at least one HES flare during the 52-week study intervention period
Measured: Up to 52 weeks
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
Measured: Baseline and up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start6 Sep 2022
- Primary completion29 Oct 2027 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypereosinophilic SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334368
- Sponsor's protocol ID
- 217013
- Other IDs
- 2021-005692-39, 2023-510346-25-00, 2023
- Acronym
- DESTINY
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)
- ClinicalTrials.gov ID
- NCT05334368
- Acronym / sponsor ID
- DESTINY / 217013
- Conditions
- Hypereosinophilic Syndrome
- Keywords
- Depemokimab, Hypereosinophilic Syndrome, DESTINY, Monoclonal antibody, Anti-interleukin -5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study.
| Arm | Type | Receives |
|---|---|---|
| Depemokimab | Experimental | Drug: DepemokimabAll participants in this arm will receive depemokimab. |
| Placebo | Placebo comparator | Other: PlaceboAll participants in this arm will receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepemokimabDepemokimab will be administered. | Drug | Depemokimab |
| PlaceboMatching placebo will be administered. | Other | Placebo |
Primary outcome
Frequency of HES flares
Time frame: Up to 52 weeks
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.
3 secondary outcomes
Time to first HES flare
Time frame: Up to 52 weeks
Number of participants with at least one HES flare during the 52-week study intervention period
Time frame: Up to 52 weeks
Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours)
Time frame: Baseline and up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
60 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depemokimab in people with Hypereosinophilic Syndrome, run by GlaxoSmithKline at 60 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Japan, South Korea, China, United States, Argentina and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of HES flares (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.