A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Citryll BV
- 入组人数
- 88
- 试验地点
- 46
- 主要终点
- The change in DAS28-CRP at week 6 compared to baseline
研究概览
简要总结
The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:
Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA.
Participants will:
Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
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
- •Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
- •Aged 18-85
- •DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
- •Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
排除标准
- •High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- •Contra-indication for CIT-013
- •Current inflammatory joint disease other than RA (Sjogren with active disease is included).
- •The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:
- •≥ 1 week for etanercept;
- •≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
- •≥ 6 months year for rituximab;
- •≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
- •Treated with ≥ 3 bDMARD or tsDMARD
- •Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
研究组 & 干预措施
CIT-013 high dose
3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose
干预措施: CIT-013 high dose (Drug)
Placebo
3 SC injections with placebo and 3 SC injections with CIT-013 medium dose
干预措施: Placebo (Drug)
CIT-013 medium dose
6 SC injections with CIT-013 medium dose
干预措施: CIT-013 medium dose (Drug)
CIT-013 low dose
3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013
干预措施: CIT-013 low dose (Drug)
结局指标
主要结局
The change in DAS28-CRP at week 6 compared to baseline
时间窗: week 6
Efficacy of CIT-013
次要结局
- Incidence of TEAEs as assessed by CTCAE(12 weeks)
- Maximum Plasma Concentration of CIT-013 before doses(4, 6, 10 and 12 weeks)