NCT02958865已完成2 期
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 319
- 试验地点
- 183
- 主要终点
- Total Mayo Score at Week 8 (Induction Period)
研究概览
简要总结
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of 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
- Double (Participant, 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
- •Diagnosis of ulcerative colitis for greater than/equal to 3 months.
- •Moderate to severe active ulcerative colitis
- •Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
排除标准
- •Pregnant or breastfeeding
- •Clinical findings suggestive of Crohn's Disease
- •History of bowel surgery within 6 months
研究组 & 干预措施
PF-06651600 Drug Dose Level 2
Experimental
Delivered orally for 8 weeks
干预措施: PF-06651600 or Placebo (Drug)
PF-06651600 Drug Dose Level 1
Experimental
Delivered orally for 8 weeks
干预措施: PF-06651600 or Placebo (Drug)
PF-06651600 Drug Dose Level 3
Experimental
Delivered orally for 8 weeks.
干预措施: PF-06651600 or Placebo (Drug)
PF-06651600 Placebo
Placebo Comparator
Delivered orally for 8 weeks.
干预措施: PF-06651600 or Placebo (Drug)
PF-06700841 Drug Dose Level 1
Experimental
Delivered orally for 8 weeks
干预措施: PF-06700841 or Placebo (Drug)
PF-06700841 Drug Dose Level 2
Experimental
Delivered orally for 8 weeks.
干预措施: PF-06700841 or Placebo (Drug)
PF-06700841 Drug Dose Level 3
Experimental
Delivered orally for 8 weeks.
干预措施: PF-06700841 or Placebo (Drug)
PF-06700841 Placebo
Placebo Comparator
Delivered orally for 8 weeks.
干预措施: PF-06700841 or Placebo (Drug)
PF-06651600 Drug Dose Level 4
Experimental
Delivered orally for 24 weeks.
干预措施: PF-06651600 (Drug)
PF-06700841 Drug Dose Level 4
Experimental
Delivered orally for 24 weeks.
干预措施: PF-06700841 (Drug)
结局指标
主要结局
Total Mayo Score at Week 8 (Induction Period)
时间窗: Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.
次要结局
- Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)(Week 8 to Week 32)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)(From Day 1 up to Week 8)
- Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)(Week 8)
- Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)(Week 8)
- Change From Baseline in Total Mayo Score at Week 8 (Induction Period)(Baseline, Week 8)
- Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)(Baseline, Weeks 4 and 8)
- Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)(From Week 8 up to Week 32)
- Number of Participants With Abnormal ECG Findings (Chronic Period)(Week 8 to Week 32)
- Number of Participants With Serious Infections (Chronic Period)(Week 8 to Week 32)
- Number of Participants With Laboratory Test Abnormalities (Induction Period)(From Day 1 up to Week 8)
- Number of Participants With Abnormal Vital Signs Data (Induction Period)(From screening to Week 8)
- Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)(Week 8)
- Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)(Week 8)
- Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)(Baseline, Weeks 2, 4 and 8)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)(Week 4 and Week 8)
- Number of Participants With Laboratory Test Abnormalities (Chronic Period)(From Week 8 to Week 32)
- Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)(Week 32)
- Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)(Week 32)
- Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)(From Week 8 to Week 32)
- Number of Participants With Abnormal Vital Signs Data (Chronic Period)(From Week 8 to Week 32)
- Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)(From Day 1 up to Week 8)
- Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)(From Day 1 up to Week 8)
- Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)(Week 8 to Week 32)
- Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)(From Day 1 up to Week 8)
- Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)(From screening to Week 8)
- Number of Participants With Serious Infections (Induction Period)(From Day 1 up to Week 8)
- Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)(Week 8)
- Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)(Week 8)
- Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)(Week 4 and Week 8)
- Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period)(Baseline, Week 4 and 8)
- Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)(Week 4 and Week 8)
- Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)(Week 4 and Week 8)
- Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)(Week 4 and Week 8)
- Total Mayo Score at Week 32 (Chronic Period)(Week 32)
研究者
研究点 (183)
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