NCT01417052已完成1 期
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing an adverse event (AE)
研究概览
简要总结
The primary objective of this study is to determine the safety of LX3305 in a dose escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects, aged 18 to 75 years
- •Active rheumatoid arthritis (RA), class I to III (defined by the American College of Rheumatology), diagnosed at least 3 months prior to Screening
- •Minimum of 4 swollen joints (at Screening and Day 1), minimum of 4 tender joints (at Screening and Day 1), and serum C-reactive protein (CRP) level >1.2x the upper limit of normal and/or elevated erythrocyte sedimentation rate (ESR)
- •If receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated for at least 6 weeks prior to Screening and currently receiving a stable dose of methotrexate (MTX) with a stable route of administration, and have no plans to change MTX dose during the study
- •Ability to give written informed consent
排除标准
- •Women who are pregnant or nursing
- •RA diagnosis prior to 16 years of age (juvenile RA)
- •Intra-articular and/or parenteral corticosteroids within 4 weeks of study Day 1
- •Receipt of live vaccine within 4 weeks prior to Day 1
- •Major surgical procedure within 8 weeks prior to Day 1
- •Blood donation within 4 weeks prior to Day 1
- •Any systemic inflammatory condition
- •History of bleeding diathesis
- •History of medically significant opportunistic infection
- •History of drug or alcohol abuse within 3 years prior to Day 1
- •History of cancer within 5 years prior to Day 1
- •Presence of hepatic or biliary disease
- •History of tuberculosis
- •History of human immunodeficiency virus (HIV)
- •Any clinically significant laboratory test results, in the opinion of the investigator
- •Use of any investigational agent or participation in an investigative trial within 30 days of Day 1
- •Concurrent use of any biologic agent for the treatment of RA or concomitant disease modifying antirheumatoid drugs (other than MTX, hydroxychloroquine, leflunomide, and sulfasalazine - at stables doses for 8 weeks)
研究组 & 干预措施
50 mg LX3305 QD
Experimental
干预措施: 50 mg LX3305 QD (Drug)
100 mg LX3305 QD
Experimental
干预措施: 100 mg LX3305 QD (Drug)
150 mg LX3305 QD
Experimental
干预措施: 150 mg LX3305 QD (Drug)
200 mg LX3305 QD
Experimental
干预措施: 200 mg LX3305 QD (Drug)
250 mg LX3305 QD
Experimental
干预措施: 250 mg LX3305 QD (Drug)
300 mg LX3305 QD
Experimental
干预措施: 300 mg LX3305 QD (Drug)
400 mg LX3305 QD
Experimental
干预措施: 400 mg LX3305 QD (Drug)
250 mg LX3305 BID
Experimental
干预措施: 250 mg LX3305 BID (Drug)
500 mg LX3305 QD
Experimental
干预措施: 500 mg LX3305 QD (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects experiencing an adverse event (AE)
时间窗: 14 weeks
次要结局
- Change from baseline in absolute lymphocyte counts(14 weeks)
- Maximum observed plasma concentration(14 weeks)
- Time at which maximum observed plasma concentration occurs(14 weeks)
- Half-life of drug in plasma(14 weeks)
- Changes from baseline in global health(14 weeks)
研究者
研究点 (1)
Loading locations...
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