2026-525242-29-00招募中3 期
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 111
- 主要终点
- 1. Event-free survival, defined as the time from randomisation to the first occurrence of any of the following adjudicated clinical outcome events: • All-cause mortality • Liver transplantation • Hepatic decompensation, • Portal hypertension syndromes: • Cholangiopathy-related events:
研究概览
简要总结
To evaluate the efficacy of daily oral administration of elafibranor 120 mg compared to placebo based on time to first occurrence of clinical outcome events in adult participants with PSC
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Subject, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults participants aged 18 years or older.
- •Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- •Compensated liver disease at screening
- •Stable background therapy, where applicable prior to study entry
- •Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
- •Ability to provide written informed consent and comply with study procedures.
排除标准
- •History or presence of other concomitant chronic liver disease
- •Administration of the following medications are prohibited as specified below: i) 3 months prior to baseline: norucholic acid, ileal bile acid transportinhibitors, fibrates, seladelpar and glitazones. ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose and as part of management of adrenal insufficiency as specified in Appendix 10.5.2); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).
- •Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV.
- •Participants with previous exposure to elafibranor.
- •Electrocardiogram (ECG) with QT interval corrected by Fridericia’s formula (QTcF) > 450 msec in males or QTcF >470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF >480 msec would be exclusionary.
- •Liver related laboratory tests.
- •Significant renal disease
- •Creatine phosphokinase (CPK) >2× ULN during SV.
- •For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.
- •Regular alcohol intake in excess of the recommended limit of two standard drinks per day for men or one standard drink per day for women
- •History of alcohol abuse, or other substance abuse within one year prior to SV.
- •Presence of hepatitis B surface antigen at SV, or hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA)
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- •Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- •Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.
- •Other medical conditions that may diminish life expectancy to <2 years.
- •History of hepatic decompensation, including: i) History of liver transplantation, ii) Current MELD 3.0 score ≥12 due to hepatic impairment, iii) Evidence of complications of cirrhosis.
- •Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score.
- •History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
- •History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
- •History or any current suspicion of cholangiocarcinoma or Hepatocellular carcinoma
- •Known malignancy or history of malignancy within the last five years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
- •Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget’s disease).
研究组 & 干预措施
Otherwise identical to the IMP
Placebo
干预措施: Otherwise identical to the IMP (Drug)
elafibranor
Test
干预措施: elafibranor (Drug)
结局指标
主要结局
1. Event-free survival, defined as the time from randomisation to the first occurrence of any of the following adjudicated clinical outcome events: • All-cause mortality • Liver transplantation • Hepatic decompensation, • Portal hypertension syndromes: • Cholangiopathy-related events:
1. Event-free survival, defined as the time from randomisation to the first occurrence of any of the following adjudicated clinical outcome events: • All-cause mortality • Liver transplantation • Hepatic decompensation, • Portal hypertension syndromes: • Cholangiopathy-related events:
次要结局
未报告次要终点
研究者
Ipsen Clinical Study Enquiries
Scientific
Ipsen Bioscience Inc.
研究点 (111)
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