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A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases (CLIPS)
EU CTIS ID: 2023-508533-14-00
What this study is testing
All cohorts:The safety and tolerability of benralizumab will be evaluated. The PK of benralizumab will be evaluated.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All Cohorts: Male or female patients 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.
- All Cohorts: 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).
- EGPA Cohort: Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).
- HES Cohort: Participants who have a documented HES diagnosis (history of persistent eosinophilia > 1500 cells/μL without secondary cause on 2 examinations (interval ≥ 1 month; Valent et al 2012) and evidence of end organ manifestations attributable to the eosinophilia).
- HES Cohort: Symptomatic active HES OR a history of a prior flare, OR those judged by the investigator as eligible based on the severity of the disease.
You likely can't join if
- All Cohorts: History of anaphylaxis to any biologic therapy or vaccine.
- HES Cohort: Diagnosis of systemic mastocytosis.
- All Cohorts: Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.
- All Cohorts: 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 Cohort: EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders patients unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).
See the full eligibility criteria
- All Cohorts: Male or female patients 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.
- All Cohorts: 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).
- EGPA Cohort: Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).
- HES Cohort: Participants who have a documented HES diagnosis (history of persistent eosinophilia > 1500 cells/μL without secondary cause on 2 examinations (interval ≥ 1 month; Valent et al 2012) and evidence of end organ manifestations attributable to the eosinophilia).
- HES Cohort: Symptomatic active HES OR a history of a prior flare, OR those judged by the investigator as eligible based on the severity of the disease.
- HES Cohort: AEC ≥ 1000 cells / μL at Visit 1 (assessed by local laboratory).
- HES Cohort: Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene translocation.
- All Cohorts: History of anaphylaxis to any biologic therapy or vaccine.
- HES Cohort: Diagnosis of systemic mastocytosis.
- All Cohorts: Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.
- All Cohorts: 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 Cohort: EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders patients unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).
- EGPA Cohort: 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.
- All Cohorts: Any current malignancy or history of malignancy.
- HES Cohort: Life-threatening HES and/or HES complication(s) as judged by the investigator.
- HES Cohort: Hypereosinophilia of unknown significance.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Brazil
- United States
- Israel
- Canada
- Turkey
- India
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Brazil; United States; Israel; Canada; Turkey and 1 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 EU CTIS; the study team decides eligibility.