EUCTR2019-002039-27-DE进行中（未招募）1 期
A Multicentre, Randomised, Double-blind, Parallel-group,Placebo-controlled, 24-Week Phase III Study with an Open-labelExtension to Evaluate the Efficacy and Safety of Benralizumab inPatients with Hypereosinophilic Syndrome (HES) - NATRO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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
- •3. Documented diagnosis of HES (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)
- •4. Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine
- •kinase gene translocation
- •5. Stable HES treatment dose(s) and regimen for for =4 weeks 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 or a documented history of 2 or more HES
- •worsening/flares within 12 months prior to Visit 1 requiring an
- •escalation in therapy.
- •-At least one flare within the past 12 months must not be related to a
- •decrease in HES therapy during the 4 weeks prior to the flare.
- •7. AEC =1000 cells/µL at Visit 1 (assessed by local laboratory)
- •8. Corticosteroid responsiveness defined as an AEC <1000 cells/µL after
- •a 2-day course of OCS (prednisone/prednisolone) 1 mg/kg/day at Visit
- •2 (assessed by local laboratory). Other OCSs in equivalent doses are
- •9. WOCBP must agree to use a highly
- •effective method of birth control (confirmed by the Investigator) from
- •enrolment, throughout the study duration, and within 12 weeks after
- •last dose of IP and have a negative urine dipstick pregnancy test result
- •10. Women not of childbearing potential are defined as women who are
- •either permanently sterilised (hysterectomy, bilateral oophorectomy, or
- •bilateral salpingectomy) or who are postmenopausal. Women will be
- •considered postmenopausal if they have been amenorrhoeic for =12
- •months prior to the planned date of enrolment without an alternative
- •medical cause
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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 randomization, (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. Definitive diagnosis of eosinophilic granulomatosis with polyangiitis
- •4. Known, preexisting, 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, 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) ALT or AST level =3× ULN during the screening period
- •(AST or ALT >5×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 or history of malignancy within 5 years before the screening
- •visit with the following exceptions:
- •(a) Patients treated for in situ carcinoma of the cervix who have
- •completed curative therapy and are in remission for at least 12 months
- •prior to signing the informed consent and
- •(b) Patients with basal cell or superficial squamous skin cancer.
- •(c) Patients who have had other malignancies are eligible provided that
- •the patient is in remission and curative therapy was completed at least 5
- •years prior to the date informed consent was obtained.
- •9. Diagnosis of systemic mastocytosis
- •10. Chronic or ongoing active infections requiring systemic treatment, as
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