A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 127
- 主要终点
- Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline
研究概览
简要总结
The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
- •Written informed consent is obtained.
- •The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
- •The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
- •The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
- •The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
- •Other criteria may apply, please contact the investigator for more information.
排除标准
- •The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
- •The patient has another confounding underlying lung disorder.
- •The patient has a known hypereosinophilic syndrome.
- •The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- •The patient is pregnant or intends to become pregnant during the study or is lactating.
- •The patient required treatment for an asthma exacerbation within 4 weeks of screening.
- •The patient is a current smoker or has a smoking history ≥10 pack-years.
- •The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
- •The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
- •The patient was previously exposed to benralizumab within 12 months of screening.
- •The patient was previously exposed to reslizumab.
- •The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
- •The patient has current suspected drug and/or alcohol abuse.
- •The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
- •The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
- •Other criteria may apply, please contact the investigator for more information.
研究组 & 干预措施
Reslizumab 110 mg
Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
干预措施: Reslizumab (Drug)
Reslizumab 110 mg
Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
干预措施: Non-Oral Corticosteroid (non-OCS) Asthma Medication (Drug)
Reslizumab 110 mg
Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
干预措施: Oral Corticosteroid (OCS) (Drug)
Placebo
Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
干预措施: Placebo (Drug)
Placebo
Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
干预措施: Non-Oral Corticosteroid (non-OCS) Asthma Medication (Drug)
Placebo
Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
干预措施: Oral Corticosteroid (OCS) (Drug)
结局指标
主要结局
Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline
时间窗: Baseline (Day 1), Weeks 20-24
The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders. No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug.
次要结局
- Annualized Rate of Clinical Asthma Exacerbations (CAEs)(Day 1 through Week 24)
- Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control(Weeks 20-24)
- Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses(Weeks 4, 8, 12, 24 or early withdrawal.)
- Participants With Adverse Events(Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.)
- Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control(Baseline (Day 1), Weeks 20-24)
- Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control(Weeks 20-24)
- Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures(Baseline (Day 1), Weeks 20-24)
- Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control(Baseline (Day 1), Weeks 20-24)