2023-508533-14-00招募中3 期
Phase III, Open-label Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Efficacy, and Immunogenicity of Benralizumab in Children with Eosinophilic Disease (CLIPS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- All cohorts:Serum Concentrations of Benralizumab
研究概览
简要总结
All cohorts:The safety and tolerability of benralizumab will be evaluated. The PK of benralizumab will be evaluated.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fasenra 30 mg solution for injection in pre-filled syringe
Test
干预措施: Fasenra 30 mg solution for injection in pre-filled syringe (Drug)
Benralizumab
Test
干预措施: Benralizumab (Drug)
结局指标
主要结局
All cohorts:Serum Concentrations of Benralizumab
All cohorts:Serum Concentrations of Benralizumab
All cohorts: Nimber of Participants with Adverse Events (AEs)
All cohorts: Nimber of Participants with Adverse Events (AEs)
次要结局
- All cohorts:Change From Baseline in Peripheral Blood Eosinophil Count
- HES Cohort: PGI-C during the treatment period
- All cohorts: Presence and characterisation of ADA
- EGPA Cohort: Proportion of participants in remission at Week 24, with remission defined as PVAS = 0 and OCS intake ≤ 0.1 mg/kg/day.
- EGPA Cohort:Time from enrolment to first EGPA relapse, where relapse is defined as any of the following:a)Active vasculitis(PVAS > 0);OR b)Worsening of asthma symptoms (based on Asthma Control Questionnaire - Interviewer Administered [ACQ-IA]); OR c) Active nasal and/or sinus disease with worsening in at least one sino-nasal symptom question warranting any of the following: 1) Increase OCS; OR 2) Increase/addition of immunosuppressive medication; OR 3) Hospitalisation related to EGPA wors
- HES Cohort:-Time to first HES worsening/flare during the Treatment Period -Proportion of participants who experience a HES worsening/flare during the treatment period - Number of HES worsening/flares (annualised rate/year) during the treatment period
- HES Cohort: Number and proportion of participants who require an increase in corticosteroid dose from baseline at any point in the Treatment Period
- HES Cohort:-Time to first haematologic relapse (AEC ≥ 1000 cells/μL) during the treatment period - Proportion of participants who have haematologic relapse duringthe treatment period - Number and proportion of participants who have AEC < 500 cells/μL for 24 weeks during the treatment period
研究者
AstraZeneca Clinical Study Information Centre
Scientific
AstraZeneca AB
研究点 (7)
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