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Investigating benralizumab for children with eosinophilic diseases

Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)

Phase 3 Interventional AstraZeneca · NCT06512883

This study is testing if a medication called benralizumab can help children aged 6 to under 18 with eosinophilic granulomatosis with polyangiitis feel better and stay healthy over a year of treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment14 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsbenralizumab
Locations15 sites (Aurora, Colorado and 14 other locations)
Trial IDNCT06512883 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter trial evaluates the safety, pharmacokinetics, pharmacodynamics, efficacy, and immunogenicity of benralizumab administered subcutaneously every four weeks in children aged 6 to under 18 with eosinophilic granulomatosis with polyangiitis (EGPA). The study consists of a screening period, a 52-week treatment period, and an optional extension period for continued treatment. Participants will receive benralizumab during the treatment phase, with the possibility of extending their participation for an additional year. The trial aims to gather comprehensive data on the drug's effects in this pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to under 18 years with eosinophilic granulomatosis with polyangiitis who are stable on corticosteroid therapy.

Not a fit: Patients with current malignancies, history of anaphylaxis to biologics, or significant pre-existing health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of eosinophilic diseases in children, leading to better health outcomes.

How similar studies have performed: Other studies have shown promise with similar biologic therapies in treating eosinophilic diseases, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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 Criteria:

All Cohorts:

* 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.
* 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:

* Life-threatening HES or HES complications, as judged by the investigator.
* Hypereosinophilia of unknown significance (HE-US).
* Diagnosis of systemic mastocytosis.

Where this trial is running

Aurora, Colorado and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic Granulomatosis With PolyangiitisHypereosinophilia Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.