A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proportion of participants with endoscopic response 50
研究概览
简要总结
This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity
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
- 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
- •Confirmed diagnosis of ileocolonic or colonic CD with at least 3 months or longer prior to the baseline;
- •Central read total SES-CD score of ≥
- •For isolated ileal disease, SES-CD total score should be ≥4;
- •An average daily liquid/very soft SF ≥4 or daily AP score ≥2.0;
- •CDAI between 220 and 450 inclusive;
- •Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD
排除标准
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC;
- •Presence of active (draining) fistulae or intra-abdominal or perineal abscesses;
- •Strictures or stenosis with obstructive symptoms;
- •Short bowel syndrome;
- •History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline;
- •Previous bowel surgery resulting in an existing stoma. Participants who have a j-pouch are excluded, as a j-pouch can result in a stoma;
- •History of bowel surgery within 6 months prior to baseline.
研究组 & 干预措施
Treatment Group 1
PF-06480605 150 mg
干预措施: Investigational Product (Drug)
Treatment Group 2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with endoscopic response 50
时间窗: Week 14
Endoscopy response 50 (SES-CD50) is defined as a reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at least 50% or more. SES-CD score assesses the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing using scales ranging from 0 to 3 in each following bowel segment: Ileum, right colon, transverse colon, left colon, rectum. The score ranges from 0 to 60 with higher score indicating more severe disease.
次要结局
- Proportion of participants achieving endoscopic mucosal healing(Week 52)
- Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission(Week 14)
- Proportion of participants achieving endoscopic remission(Week 52)
- The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170(Week 14)
- Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.(up to week 52)
- Incidence of development of severe and serious infections(Up to week 52)
- Proportion of participants achieving endoscopic response(Week 52)
- Proportion of participants with a CDAI clinical remission(up to week 52)
- Proportion of participants with a CDAI clinical response(Up to week 52)
- Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response(Up to week 52)
- Proportion of participants achieving PRO2 clinical remission(Up to week 52)