A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Safety and tolerability of imvotamab
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.
Participants will be given imvotamab through a vein (i.e., intravenously).
详细描述
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be assigned to different sequentially dose escalation cohorts.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of signing ICF
- •Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
- •Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
- •Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
- •It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week
排除标准
- •Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
- •Any lupus-associated neuropsychiatric disease.
- •Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
- •Prednisone-equivalent > 30 mg/day, including immediate and extended-release oral formulations.
- •Drug-induced lupus.
- •Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.
研究组 & 干预措施
Imvotamab (Dose Escalation)
Imvotamab administered intravenously
干预措施: Imvotamab (Drug)
结局指标
主要结局
Safety and tolerability of imvotamab
时间窗: Up to Week 52
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections
次要结局
未报告次要终点