A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults with Hypereosinophilic Syndrome (HES)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510346-25-00

Acronym

217013

Enrollment

Registered

2024-08-01

Start date

2022-09-01

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypereosinophilic Syndrome (HES)

Brief summary

Frequency of HES flares during the 52-week study intervention period

Detailed description

Time to first HES flare (days), At least one HES flare during the 52-week study intervention period, Change from Baseline to Week 52 in Brief Fatigue Inventory (BFI) item 3 weekly average score., Change from Baseline to Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a score

Interventions

DRUGPlacebo for Depemokimab Injection

DRUGPlacebo for Prednisolone

DRUGPREDNISOLONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency of HES flares during the 52-week study intervention period	—

Secondary

Measure	Time frame
Time to first HES flare (days), At least one HES flare during the 52-week study intervention period, Change from Baseline to Week 52 in Brief Fatigue Inventory (BFI) item 3 weekly average score., Change from Baseline to Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a score	—

Countries

Belgium, Czechia, Denmark, Germany, Greece, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026