Last updated: 11/24/2025 05:30:12
Depemokimab in participants with hypereosinophilic syndrome, efficacy, and safety trialDESTINY
GSK study ID
217013
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults with Hypereosinophilic Syndrome (HES)
Trial description: 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 depemokimabor placebo while continuing their SoC HES therapy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Frequency of HES flares
Timeframe: Up to 52 weeks
Secondary outcomes:
Time to first HES flare
Timeframe: Up to 52 weeks
Number of participants with at least one HES flare during the 52-week study intervention period
Timeframe: 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)
Timeframe: Baseline and up to Week 52
Interventions:
Enrollment:
123
Primary completion date:
2028-19-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypereosinophilic Syndrome
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2022 to December 2028
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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-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 location(s)
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Recruiting
Location
GSK Investigational Site
Rochester, MN, United States, 55905
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Southfield, MI, United States, 48075
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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