NCT06512883RecruitingPhase 3
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 17 Jul 2024
- Start date
- Apr 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- AstraZeneca
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT06512883
- EU CT number
- 2023-508533-14-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 14
- From Apr 2025 to the primary completion date, Feb 2028
- 15 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- 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.
Other
- All Cohorts:
- Life-threatening HES or HES complications, as judged by the investigator.
- Hypereosinophilia of unknown significance (HE-US).
- Diagnosis of systemic mastocytosis.
Who the study is looking for
- 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.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.