NCT01284062已完成2 期
A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 84
- 试验地点
- 151
- 主要终点
- Fold Change From Baseline in Fecal Calprotectin at Week 14
研究概览
简要总结
This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, Age >=18 and <=65 years
- •Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
- •women of childbearing potential with highly effective method of contraception
排除标准
- •Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.
研究组 & 干预措施
Arm 4
Placebo Comparator
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
干预措施: placebo (Other)
结局指标
主要结局
Fold Change From Baseline in Fecal Calprotectin at Week 14
时间窗: Baseline, Week 14
The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.
次要结局
- Volume of Distribution (Vz) for Anrukinzumab(Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 32)
- Number of Participants Who Discontinued From the Study Due to Adverse Events(Baseline up to Week 32)
- Plasma Decay Half-Life (t1/2) for Anrukinzumab(Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32)
- Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab(Pre-dose to end of the dosing interval after Day 1, Week 12)
- Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab(Pre-dose to end of the dosing interval after Day 1, Week 12)
- Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14(Baseline, Week 14)
- Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody(Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab(Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2)
- Systemic Clearance (CL) for Anrukinzumab(Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32)
- Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, 12)
- Total Interleukin-13 (IL-13) Level(Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32)
研究者
研究点 (151)
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