A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma (PATH-HOME)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 216
- 试验地点
- 37
- 主要终点
- Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type
研究概览
简要总结
This is a multicenter, randomized, open-label, parallel-group study designed to assess healthcare provider and subject/caregiver reported functionality and performance of a single-use accessorized pre-filled syringe (APFS) or autoinjector (AI) with a fixed 210 mg dose of tezepelumab administered subcutaneously in the clinic and in an at-home setting.
详细描述
The study will consist of a screening/run-in period of up to 2 weeks and a treatment period of 24 weeks, followed by a post-treatment follow-up period of 12 weeks. During the treatment period, one dose of 210 mg tezepelumab will be administered via a single-use APFS or AI subcutaneously (SC) every 4 weeks (Q4W) starting at Visit 2 (Week 0) until Visit 7 (Week 20). Subjects will be administered tezepelumab at the site during Visits 2 (Week 0), 3 (Week 4), 4 (Week 8) and 7 (Week 20). At-home administration of tezepelumab will occur during Visit 5 (Week 12) and Visit 6 (Week 16). Each device will be assessed separately using descriptive presentations.
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
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 12 to 80 years.
- •Documented physician-diagnosed asthma for at least 12 months.
- •Evidence of asthma as documented by post BD (albuterol/salbutamol) reversibility of FEV1 ≥ 12% AND ≥200 mL (15-60 min after administration of 4 puffs of albuterol/salbutamol), documented either: in the previous 12 months prior to V1, OR demonstrated at V1, V1A, or at V
- •Documented history of current treatment with medium- or high-dose ICS for at least 6 months and at least one additional asthma controller medication according to standard practice of care. ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily.
- •Morning pre-BD FEV1 of >50% predicted normal at Visit 1, Visit 1A, or Visit 2.
排除标准
- •Clinically important pulmonary or systemic diseases other than asthma.
- •History of cancer except basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma of the cervix within 12 months prior to Visit
- •Acute upper or lower respiratory infection requiring antibiotics or antiviral medications finalized <2 weeks before Visit 1 or during screening/run-in period.
- •A helminth parasitic infection diagnosed within 6 months that is untreated or is unresponsive to the standard of care.
- •Smoking history of ≥10 pack years, (includes vaping and e-cigarettes)
- •History of chronic alcohol or drug abuse.
- •Tuberculosis requiring treatment within 12 months prior to V
- •History of HIV, Hepatitis B or Hepatitis C.
- •Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives.
- •Bronchial thermoplasty in 24 months prior to V
- •Anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) to any biologic therapy.
- •Evidence of active liver disease (e.g. jaundice, AST, ALT or ALP >2 times upper limit of normal), ongoing liver disease or inexplicably elevated liver chemistry values.
- •Pregnant, breastfeeding or lactating women.
- •Non-leukocyte depleted whole blood transfusion in 120 days prior to visit 1.
结局指标
主要结局
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type
时间窗: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Successful administration is defined as an injection completed, based on a used/returned (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned/evaluated devices.
次要结局
- Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score(Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24)
- Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction(Week 0, Week 4, Week 8, Week 12, Week 16, Week 20)
- Serum Trough Concentrations(Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT))
- Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints)(Week 0, Week 4, Week 8, Week 12, Week 16, Week 20)
- Anti-drug Antibodies (ADA)(Pre-treatment on dosing days until end of follow-up (Week 36) per protocol)