NCT07688980尚未招募1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 92
- 主要终点
- Anifrolumab serum concentrations through Week 4
研究概览
简要总结
The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).
详细描述
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Cervical cancer in situ treated with apparent curative success ≥ 1 year prior to Day 1.
结局指标
主要结局
Anifrolumab serum concentrations through Week 4
时间窗: Up to Week 4
To characterise the PK exposure of SC or IV anifrolumab.
次要结局
- Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker(Up to Week 4)
研究者
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