NCT05525520已完成2 期
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 52
- 主要终点
- Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6
研究概览
简要总结
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
- •Presence of consistent moderate to severe pruritus
- •Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria
- •Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria
排除标准
- •Pruritus associated with an etiology other than PBC or PSC
- •Prior or planned liver transplantation
- •Evidence of compensated or decompensated cirrhosis
- •Alternative causes of liver disease
- •Presence of documented secondary sclerosing cholangitis
- •Current evidence of clinically significant high-grade strictures or presence of biliary stent
- •History of significant small bowel resection or short bowel syndrome
- •Has exclusionary laboratory or biochemical results at Screening
研究组 & 干预措施
EP547 100 mg
Experimental
干预措施: EP547 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6
时间窗: Baseline; up to Week 6
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
次要结局
- Change From Baseline in the 5-D Itch Scale Total Score at Week 6(Baseline; Week 6)
- Percentage of Participants With Improvement in Pruritus as Defined by Patient Global Impression of Change (PGI-C) at Week 6(Baseline; Week 6)
- Percentage of Participants With Improvement in Pruritus Severity From Baseline as Defined by Change in Patient Global Impress of Severity (PGI-S) at Week 6(Baseline; Week 6)
- Percentage of Participants With a Reduction in WI-NRS Score ≥2 From Baseline at Week 6(Baseline; Week 6)
- Percentage of Participants With a Reduction in WI-NRS Score ≥3 From Baseline at Week 6(Baseline; Week 6)
- Percentage of Participants With a Reduction in WI-NRS Score ≥4 From Baseline at Week 6(Baseline; Week 6)
- Percentage of Participants With a WI-NRS Score <4 at Week 6(Baseline; Week 6)
- Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug(up to the end of Week 6)
- Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug(from the beginning of Week 7 up to Week 12)
- Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug(up to the end of Week 6)
- Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug(from the beginning of Week 7 up to Week 12)
- Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug(up to the end of Week 6)
- Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug(from the beginning of Week 7 up to Week 12)
- Number of Participants With Any Clinically Meaningful Changes From Baseline in Clinically Meaningful in Clinical Laboratory Test Results(up to the end of Week 12)
- Number of Participants With Any Clinically Meaningful Changes From Baseline in Vital Sign Measurements(up to the end of Week 12)
- Number of Participants With Any Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters(up to the end of Week 12)
- Plasma Concentration of EP547 and Metabolites(1, 2, and 3 hours postdose on Day 1 and Week 3; predose on Weeks 1, 2, and 6)
研究者
研究点 (52)
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