A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

AstraZeneca KK0 个研究点目标入组 8 人开始时间: 2020年6月16日最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: AstraZeneca KK
入组人数: 8

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 12age old 至 ot applicable（—）
性别: All

入选标准

•1. Provision of the signed and dated written informed consent of the patient or the patient's legally authorised representative, and informed assent from the patient (per local regulations) prior to any mandatory study-specific procedures, sampling, and analyses.
•2. Males and females 12 years of age and older at the time of signing the ICF.
•3. Documented diagnosis of HES (history of persistent eosinophilia >1500 cells/microliter without secondary cause on 2 examinations [interval 1 month or more; Valent et al 2012] and evidence of end organ manifestations attributable to the eosinophilia).
•4. Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene translocation.
•5. Stable HES treatment dose(s) and regimen for 4 weeks or more at the time of Visit 1
•6. Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of HES worsening/flare (other than isolated eosinophilia) at Visit 1.
•7. AEC 1000 cells/ microliter or more at Visit 1 (assessed by local laboratory).
•8. Corticosteroid responsiveness defined as an AEC <1000 cells/microliter after a 2-day course of OCS 1 mg/kg/day at Visit 2 (assessed by local laboratory).
•9. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control (confirmed by the Investigator) from enrolment, throughout the study duration, and within 16 weeks (5 half-lives) after last dose of IP and have a negative urine dipstick pregnancy test result on Visit 1

排除标准

•1. Life-threatening HES and/or HES complication(s) as judged by the Investigator:
•a. Medical intervention for HES-related life-threatening event(s) within 12 weeks prior to randomisation OR
•b. History of thrombotic complications, stroke, or significant cardiac damage related to HES, if the respective events were life threatening and currently represent a risk of life-threatening disease complications. Events that occurred in the past but considered resolved or stable, can be accepted if, as per Investigator's judgment participation in the study will not put the patient at risk.
•c. Disease severity that, in the opinion of the Investigator, makes the patient inappropriate for inclusion in the study.
•2. Presence of FIP1L1-PDGFRA fusion tyrosine kinase gene translocation or other known imatinib-sensitive mutation.
•3. Clinical diagnosis of eosinophilic granulomatosis with polyangiitis.
•4. Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities that are not associated with HES and are uncontrolled with standard treatment which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete the entire duration of the study.
•5. Hypereosinophilia of unknown significance.6.Cardiovascular: Documented history of any clinically significant cardiac damage prior to Visit 1 that, in the opinion of the Investigator, would impact the patient's participation during the study and/or clinically significant echocardiography findings within 12 months prior to Visit 1, if available
•6. Cardiovascular: Documented history of any clinically significant cardiac damage, clinically significant echocardiography (if available) or ECG findings within 12 months prior to Visit 1 or clinically significant ECG findings at screening that, in the opinion of the Investigator, may put the patients at risk.
•7. Known currently active liver disease.
•a. Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen or hepatitis C antibody) or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis.
•b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level 3 times the upper limit of normal (ULN) or more during the screening period (AST or ALT >5 time ULN if documented HES with liver manifestations). Transient increase of AST/ALT level that resolves by the time of randomisation is acceptable if, in the Investigator's opinion, the patient does not have an active liver disease and meets other eligibility criteria.
•8. Current malignancy, or history of malignancy, except:
•a. Patients who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided the patient is in remission and curative therapy was completed at least 12 months prior to the date that informed consent, and assent when applicable, was obtained.
•b. Patients who have had other malignancies are eligible provided the patient is in remission and curative therapy was completed at least 5 years prio

研究者

发起方

AstraZeneca KK

相似试验

招募中

3 期

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)

NL-OMON54266Astra Zeneca3

招募中

1 期

A study to evaluate if benralizumab may be beneficial in the treatment of Hypereosinophilic Syndrome (HES)

EUCTR2019-002039-27-ESAstraZeneca AB120

进行中（未招募）

1 期

A study to evaluate if benralizumab may be beneficial in the treatment of Hypereosinophilic Syndrome (HES)Hypereosinophilic Syndrome (HES)MedDRA version: 20.0Level: PTClassification code 10048643Term: Hypereosinophilic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders

EUCTR2019-002039-27-ITASTRAZENECA AB120

进行中（未招募）

1 期

Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasison-cystic fibrosis bronchiectasis (NCFB)MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

EUCTR2020-004068-24-ITASTRAZENECA AB420

进行中（未招募）

1 期

EUCTR2019-002039-27-DEAstraZeneca AB120