Tests benralizumab in children with rare blood-eosinophil disorders
Tests benralizumab in children aged 6 to 17 with eosinophilic granulomatosis or hypereosinophilia syndrome.
Plain-language title generated from the registry record
Registry title: A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Key facts
- Where
- Lille and Montpellier, FranceSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT06512883, who can take part
Where in France
- LilleLille, FranceTaking people
- MontpellierMontpellier, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06512883EU 2023-508533-14-00
- Record updated
- 28 October 2026
- Original description
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.Read full original descriptionShow less
Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Inclusion: All Cohorts:; Male or female participants must be aged 6 to < 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form; Body weight greater than (>=) 15 kilograms (kg); EGPA Cohort:; Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than [>] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2); Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2); HES Cohort:; Documented HES diagnosis, defined as history of persistent eosinophilia >1500 cells/µL without secondary cause on 2 examinations ≥1 month apart and evidence of eosinophil-mediated organ involvement; Symptomatic active HES, or history of a prior flare, or considered eligible based on disease severity per investigator judgement; AEC ≥1000 cells/µL at screening (Visit 1); Documented negative testing for Fip1-like 1 gene fused with the platelet-derived growth factor receptor alpha gene (FIP1L1-PDGFR) fusion tyrosine kinase gene translocation.
Exclusion: Previous receipt of benralizumab in an interventional clinical study; EGPA Cohort:; Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis; EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders participants unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2); Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement; HES Cohort:; Any current malignancy or history of malignancy; History of anaphylaxis to any biologic therapy or vaccine; Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities; All Cohorts:; Life-threatening HES or HES complications, as judged by the investigator; Hypereosinophilia of unknown significance (HE-US); Diagnosis of systemic mastocytosis.