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New treatment option for Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Official title A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
ClinicalTrials.gov ID: NCT06512883
What this study is testing
What is Benralizumab?
Benralizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for eosinophilic granulomatosis with polyangiitis (egpa).
Also referred to as FASENRA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
- 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)...
- Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2). HES...
You likely can't join if
- 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...
- Previous receipt of benralizumab in an treatment clinical study. EGPA Cohort:
- Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.
See the full eligibility 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...
- 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.
- 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 treatment 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Cincinnati, Ohio, United States
- Highland Hills, Ohio, United States
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Lille, France
- Montpellier, France
- Ahmedabad, India
- Petah Tikva, Israel
- Guadalajara, Mexico
- Rotterdam, Netherlands
- Kielce, Poland
- Warsaw, Poland
- Altındağ, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Cincinnati, Ohio, United States; Highland Hills, Ohio, United States; São Paulo, Brazil; Toronto, Ontario, Canada; Lille, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.