EUCTR2019-001800-39-BE进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group,Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety ofBenralizumab 100 mg in Patients with Moderate to Very Severe ChronicObstructive Pulmonary Disease (COPD) with a History of Frequent COPDExacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE) - RESOLUTE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 642
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 informed consent
- •2 Age 40 to 85 years
- •3 Male and/or female.
- •4 Current or former smoker with a tobacco history of =10 pack-years.
- •5 History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 =65% of predicted normal value.
- •6 Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.
- •(a) Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.
- •(b) Hospitalization is defined as an inpatient admission =24 hours
- •(c) Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.
- •(d) At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.
- •7 Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for =3 months immediately prior to enrollment.
- •(a) Treatment with at least double inhaled therapy containing ICS for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.
- •(b) ICS in a dose approved for COPD or equivalent to =250 mcg of fluticasone propionate daily
- •(c) Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.
- •(d) Stable therapy/doses for the last 3 months prior to randomization.
- •8 Blood eosinophil count =300/µL at screening and documented historical eosinophil count of =150/µL within 52 weeks of enrollment (or repeated testing during run-in).
- •9 CAT total score =15 at Visit 1.
- •10 Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.
- •11 Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.
- •Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 321
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 321
排除标准
- •1 Clinically important pulmonary disease other than COPD
- •2 Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before theage of 18.
- •3 Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.
- •4 Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- •5 Any unstable disorder that could affect patient safety, study findings or the patient’s ability to complete the study.
- •6 Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient’s ability to complete the study.
- •7 Cor pulmonale and/or right ventricular failure.
- •8 Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.
- •9 Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.
- •10 Known immunodeficiency disorder, including positive HIV-1/2 testing.
- •11 Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.
- •12 ALT or AST =3 times the upper limit of normal, confirmed by repeated testing during the run-in period.
- •13 Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.
- •14 Alcohol or drug abuse within the past year, which may compromise the study data.
- •15 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.
- •16 Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.
- •17 Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).
- •18 History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
- •19 Scheduled major surgical procedure during the study. Minor elective procedures are allowed.
- •20 History of anaphylaxis to any biologic therapy or vaccine.
- •21 Receipt of blood products or immunoglobulins within 30 days prior to randomization.
- •22 Receipt of marketed or investigational biologic product within 4
- •months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab, for examp
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