A Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Adult Participants With Active, Refractory Moderate-Severe Idiopathic Inflammatory Myopathies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 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 Moderate-Severe Idiopathic Inflammatory Myopathies 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, open-label study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active, refractory, moderate-severe Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.
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 probable or definite IIM according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for IIM with subgroup classification of either DM, polymyositis (PM), anti-synthetase syndrome, or immune-mediated necrotizing myositis (IMNM).
- •Active IIM despite treatment with corticosteroids and at least 1 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment.
- •If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment
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.
- •Receipt of an investigational therapy less than 12 weeks or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study.
- •Has inclusion body myositis or myositis-associated with other connective tissue disease.
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: Time Frame: Up to Week 50
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious
次要结局
未报告次要终点