A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 11
- 主要终点
- This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 6 swollen and at least 6 tender joints
- •C-reactive Protein (CRP) > Upper Limit Normal (ULN)
- •Prior inadequate response from biologic therapy
- •Stable regimens of concomitant RA therapies
排除标准
- •Unstable medical conditions
研究组 & 干预措施
Placebo
干预措施: Placebo Comparator (Other)
结局指标
主要结局
This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
时间窗: Weeks 14 & 30
KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)
次要结局
未报告次要终点