A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 7
- 主要终点
- Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo
研究概览
简要总结
This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •* Must be able to provide written informed consent
- •* Body mass index 18.5 to 35.0 kg/m2
- •* Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
- •* Global Functional Class I, II, or III according to ACR 1991 revised criteria
- •* Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
- •* Use of \>/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for \>/= 2 weeks prior to randomization
- •* Use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 3 months and a stable dose for \>/= 6 weeks prior to randomization
- •* Stable use of low dose oral corticosteroids (\/= 4 weeks prior to randomization
排除标准
- •Prior to Day 0, use of:
- •Rituximab within 6 months
- •Abatacept within 3 months
- •Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
- •Etanercept, Anakinra, immunoglobulin or blood products within 28 days
- •Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer
- •Prior exposure to T cell depleting agents such as Campath (alemtuzumab)
- •Evidence of any active or recent infection
- •History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
- •History of allergic reactions
- •History of anaphylaxis or allergic diathesis
- •Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
- •Evidence of active or latent tuberculosis
- •Vaccination with live attenuated viruses within the 2 weeks prior to Day 0
- •Pregnant or breastfeeding women
研究组 & 干预措施
Crossover Group 2
Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week
干预措施: Placebo (Other)
Crossover Group 1
Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo
干预措施: AMP-110 (Biological)
结局指标
主要结局
Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo
时间窗: From start of study drug administration through Day 112
Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
Repeat dose pharmacokinetic parameters of AMP-110 in serum
时间窗: From start of study drug administration through Day 112
Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
次要结局
- Optimal dose for repeat dosing of AMP-110(From start of study drug administration through Day 112)