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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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)

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases (NCT06512883) is a Phase 3 interventional studying Eosinophilic Granulomatosis With Polyangiitis (EGPA) and Hypereosinophilia Syndrome (HES), sponsored by AstraZeneca. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Eosinophilic Granulomatosis With Polyangiitis (EGPA), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 14 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Benralizumab

Benralizumab will be administered as SC injection on Q4W.

Locations (15)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Research Site
Aurora, Colorado, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Highland Hills, Ohio, United States
Research Site
São Paulo, Brazil
Research Site
Toronto, Ontario, Canada
Research Site
Lille, France
Research Site
Montpellier, France
Research Site
Ahmedabad, India
Research Site
Petah Tikva, Israel
Research Site
Guadalajara, Mexico
Research Site
Rotterdam, Netherlands
Research Site
Kielce, Poland
Research Site
Warsaw, Poland
Research Site
Altındağ, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06512883), the sponsor (AstraZeneca), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06512883 clinical trial studying?

The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06512883?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06512883?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06512883. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06512883. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.