NCT07230353招募中1 期
A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Xencor, Inc.
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- Primary
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.
详细描述
This is a Phase 1b study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of plamotamab in adult participants with moderately to severely active RA. This is an open label dose optimization trial with approximately 68 participants assigned to different 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
- •Adult participants with moderately to severely active RA.
- •Documented diagnosis of RA and meeting the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for RA at least 3 months prior to screening
- •Inadequate response to, loss of response to, or intolerance to available RA therapies.
- •Stable doses of RA medications prior to screening
- •Use of highly effective methods of contraception
排除标准
- •Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
- •Recurrent infections or active clinically significant infection
- •Active or untreated latent tuberculosis
- •Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
- •Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- •Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
研究组 & 干预措施
Dose Escalation
Experimental
Plamotamab administered SC
干预措施: Plamotamab (Biological)
结局指标
主要结局
Primary
时间窗: Through Week 52
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
次要结局
- Secondary(Through Week 52)
研究者
研究点 (5)
Loading locations...
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