NCT07229144尚未招募1 期
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
Ouro Medicines0 个研究点目标入组 39 人开始时间: 2025年11月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 主要终点
- Safety and Tolerability
研究概览
简要总结
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.
详细描述
An open-label, multicenter, multiple ascending dose study evaluating safety, tolerability, and PK/ADA profile of OM336 in seropositive autoimmune diseases. Exploratory assessments include clinical response and biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of active seropositive autoimmune disease
- •Relapsed/refractory after ≥2 prior/ongoing treatments
- •Body weight ≥ 50 kg
- •Willing to comply with and study requirements and procedures
排除标准
- •Previous treatment with a BCMA-targeted therapy
- •Clinically significant infection within 3 months of screening
- •Major surgery within 3 months of screening or planned during the study
- •Pregnant or breastfeeding
研究组 & 干预措施
OM336 Dose Escalation
Experimental
Participants will receive OM336 via subcutaneous injection in ascending dose cohorts
干预措施: OM336 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 12 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
次要结局
- Safety and Tolerability(52 weeks)
- To assess the pharmacokinetics (PK) of OM336(12 weeks)
- Detection of anti-drug antibodies(12 weeks)
研究者
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