NCT05549323终止1 期
A PHASE 1B, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MILD TO SEVERE ULCERATIVE COLITIS
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 44
- 试验地点
- 33
- 主要终点
- Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.
研究概览
简要总结
This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.
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 moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline.
- •Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
- •Part A (moderate to severe): Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least
- •Part B (mild to moderate): Participants with mMS of 4 to 6, ES of ≥2 and RB score of ≥1
- •Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
- •Total body weight >40 kg (88.2 lb).
排除标准
- •Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.
- •History of bowel surgery within 6 months prior to baseline.
- •History of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study.
- •Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
- •Clinically significant infections within 6 months of baseline
研究组 & 干预措施
Treatment Group 1
Experimental
Oral PF-07054894
干预措施: PF-07054894 (Drug)
Treatment Group 2
Placebo Comparator
Matched Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.
时间窗: Week 12
Clinical remission based on modified Mayo Score is defined as endoscopic subscore equal 0 or 1 (without friability), stool frequency subscore equal 0 or 1, and rectal bleeding subscore equal 0
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.
时间窗: Week 12
次要结局
- Part A: Proportion of participants with clinical remission at Week 12(Week 12)
- Part B: Proportion of participants achieving clinical remission at Week 12(Week 12)
- Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12(Week 12)
研究者
研究点 (33)
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