A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.
详细描述
Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability.
The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate
- •between 18 and 75 years of age, inclusive.
排除标准
- •Patients who are currently pregnant or breastfeeding.
- •Patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy.
- •Patients with a history of any other inflammatory or arthritic disease in addition to RA that may interfere with the study.
研究组 & 干预措施
MBS2320
干预措施: MBS2320 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: 12 weeks
Incidence of all grade adverse events
次要结局
- Disease Activity Score 28 (DAS28)(12 weeks)