A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 357
- 试验地点
- 189
- 主要终点
- Percentage of Participants in Clinical Remission at Week 12
研究概览
简要总结
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
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
- •Subjects with diagnosis of Ulcerative Colitis for 3 or more months.
- •Ulcerative colitis must be active beyond the rectum.
- •Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points
排除标准
- •Pregnant or breast feeding.
- •Diagnosis of indeterminate colitis or Crohn's Disease
- •Subjects with history of colonic or small bowel obstruction or resection.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Drug Dose Level 1
干预措施: PF-00547659 SC Injection (Drug)
Drug Dose Level 2
干预措施: PF-00547659 SC Injection (Drug)
Drug Dose Level 3
干预措施: PF-00547659 SC Injection (Drug)
Drug Dose Level 4
干预措施: PF-00547659 SC Injection (Drug)
结局指标
主要结局
Percentage of Participants in Clinical Remission at Week 12
时间窗: Week 12
Clinical remission was defined as a Total Mayo Score of less than or equal (\<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
次要结局
- Percentage of Participants With Mucosal Healing at Week 12(Week 12)
- Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12(Baseline (BL), Week 12)
- Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12(Baseline, Week 12)
- Percentage of Participants With Clinical Response at Week 12(Week 12)
- Change From Baseline in Total Mayo Score at Week 12(Baseline, Week 12)
- Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12(Baseline; Weeks 4, 8, and 12)
- Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12(Baseline, Week 12)
- Maximum Serum PF-00547659 Concentration Achieved(Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal)
- Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12(Weeks 4, 8, and 12)
- Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12(Baseline; Weeks (W) 4, 8, and 12)
- Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12(Baseline, Weeks 4, 8, and 12)
- Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12(Week 12)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)(Screening through to end of treatment period, up to 12 weeks)