An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 391
- 试验地点
- 134
- 主要终点
- Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)
- •~~ Additional criteria apply, please contact the investigator for more information
排除标准
- •Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-
- •The patient has any clinically significant, uncontrolled medical condition
- •The patient has another confounding underlying lung disorder
- •The patient has a known/diagnosed hypereosinophilic syndrome.
- •The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- •The patient is a pregnant or lactating woman
- •The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
- •The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS
- •The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
- •The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
reslizumab 110 mg
Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.
干预措施: reslizumab (Drug)
结局指标
主要结局
Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
次要结局
- Participants With Potentially Clinically Significant Abnormal Hematology Values(Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits)
- Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values(Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits)
- Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity(Weeks 4, 8, 12, 16, 20, 24, 28, and 36)
- Participants With Potentially Clinically Significant Abnormal Vital Sign Values(Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits)
- Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36(Baseline (Week 0), Weeks 8, 24, 36)
- Annualized Rate of Clinical Asthma Exacerbations (CAEs)(Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.)
- Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits(Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.)
- Mean Number of Days of Hospital Stay During the Treatment Period(Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug)
- Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period(Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug)
- Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36(Week 0 (baseline), Weeks 8, 24, 36)
- Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36(Week 0 (baseline), Weeks 1, 4, 8, 24, 36)
- Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36(Week 0 (baseline), Weeks 16-20, Weeks 32-36)
- Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36(Baseline (Week 0), Weeks 1, 4, 8, 24, 36)
- Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36(Baseline (Week 0), Weeks 8, 24, 36)
- Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses(Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal)
- Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)(Week 51)