Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)
A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus
研究概览
地位
条件
详细说明
This is a multicentre, randomised, phase I open-label study.
The study will comprise of the following:
- Screening period: Up to 30 days
- Two treatment periods
- Part A: Randomised SC vs IV Treatment Period: 5 weeks
- Part B: Optional Extended Treatment Period: Up to 47 weeks
- Safety follow-up period: 12 weeks after the final dose
Part A will include all participants who will be randomised into SC anifrolumab via autoinjector (AI) or IV anifrolumab.
Part B is an optional extended treatment period where participants will receive SC anifrolumab via accessorised prefilled syringe (aPFS).
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：AstraZeneca Clinical Study Information Center
- 电话号码：1-877-240-9479
- 邮箱：information.center@astrazeneca.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Participants who have a diagnosis of adult SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 criteria for ≥ 24 weeks prior to signing the informed consent form (ICF).
- "Clinical" Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4 points at Screening.
- Antinuclear antibody (ANA)-positive at Screening.
- Must be on stable background standard therapy with oral corticosteroids (OCS), antimalarials, and/or immunosuppressants alone or in combination.
Exclusion Criteria:
- Active severe or unstable neuropsychiatric SLE.
- Active severe SLE-driven renal disease.
- Known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection, or a positive result for Human Immunodeficiency Virus (HIV) infection confirmed by central laboratory at Screening.
- At Screening, confirmed positive test for hepatitis B serology or positive test for hepatitis C antibody.
- Any severe case of herpes zoster infection at any time prior to Week 0 (Day 1).
- Opportunistic infection requiring hospitalisation or IV antimicrobial treatment within 3 years of randomisation
History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin treated with documented curative success ≥ 3 months prior to Day 1.
- Cervical cancer in situ treated with apparent curative success ≥ 1 year prior to Day 1.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Part A: SC
Participants will receive SC anifrolumab administered via AI.
|
Anifrolumab will be administered subcutaneously via an AI.
|
|
实验性的：Part A: IV
Participants will receive IV anifrolumab infusion.
|
Anifrolumab will be administered intravenously.
|
|
实验性的：Part B
Participants will receive SC anifrolumab administered via aPFS.
|
Anifrolumab will be administered subcutaneously via an aPFS.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anifrolumab serum concentrations through Week 4
大体时间：Up to Week 4
|
To characterise the PK exposure of SC or IV anifrolumab.
|
Up to Week 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker
大体时间：Up to Week 4
|
To characterise the PD of SC or IV anifrolumab.
|
Up to Week 4
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part A and B: Number of participants with adverse events (AEs)
大体时间：Up to Week 64
|
To characterise the safety and tolerability of SC or IV anifrolumab in Part A and as SC administration alone in Part B.
|
Up to Week 64
|
合作者和调查者
赞助
合作者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- D3466C00003
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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