NCT04988997终止2 期
A Phase 2, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study of the Efficacy, Safety, and Tolerability of Vurolenatide in Adult Patients With Short Bowel Syndrome
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 24hr total stool output volume
研究概览
简要总结
A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome.
详细描述
A Phase 2 study of Vurolenatide in adult patients with SBS. Patients were planned to be dosed in four treatment groups with placebo and/or active Vurolenatide. The study is 13 weeks (3 weeks screening, 4 weeks SC study drug administration, and 6 weeks of follow up). Safety and efficacy will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind, Double-Dummy, Placebo-Controlled.
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
- •Criteria for patient inclusion in this study are as follows:
- •Male and female adults with SBS secondary to surgical resection of small intestine
- •18-75 years of age at the time of screening.
- •Female patients must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. If oral contraceptives are used, patients must have been on a stable dose for ≥6 months.
- •Male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose. Male patients should not donate sperm for 90 days after last dose.
- •At least 6 months since last surgical bowel resection.
- •Patients may be on Parenteral Support [PS] (nutrition and/or fluid and electrolytes for at least some of their nutritional needs).
- •If on PS, stable administration of PS volume for 1 month (±20% vol) prior to enrollment [stable administration of PS volume confirmed by Medical Monitor].
- •Able to ingest solid or semi-solid foods and drink.
排除标准
- •Criteria for exclusion from participation in this study are presented below.
- •Pregnancy or lactation
- •Body mass index at screening <18 or >30 kg/m2
- •Clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study
- •Active Crohn's disease or IBD (as evaluated by standard procedures employed by the investigator/institution). If in remission, must be ≥12 weeks of remission prior to screening
- •Inflammatory bowel disease patients who have NOT been on a stable drug treatment regimen for at least the past 3 months prior to screening
- •Visible blood in the stool within the last 3 months
- •Known heart failure or active coronary disease
- •Alcohol or drug abuse within the last 12 months by history, or a disqualifying positive urine drug test at screening.
- •Inadequate renal function as defined by serum creatinine <0.7 or >1.3 mg/dL (in men) and <0.6 or >1.1 mg/dL in women.
- •Personal or family history of medullary thyroid cancer.
- •History of pancreatitis
- •Any use of growth hormone, or growth factors such as native GLP-2 or GLP-2 analog (teduglutide) within the last 3 months
- •Use of antibiotics within the last 30 days
- •Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
研究组 & 干预措施
Vurolenatide 50 mg/PBO
Active Comparator
50 mg biweekly SC administration, PBO alternate weeks
干预措施: Vurolenatide 50mg/PBO (Drug)
Vurolenatide 100 mg/PBO
Active Comparator
100 mg biweekly SC administration, PBO alternate weeks
干预措施: Vurolenatide 100mg/PBO (Drug)
Vurolenatide 50/50 mg
Active Comparator
50 mg weekly SC administration
干预措施: Vurolenatide 50/50 mg (Drug)
Placebo
Placebo Comparator
PBO - weekly SC administration
干预措施: Placebo (Drug)
结局指标
主要结局
24hr total stool output volume
时间窗: 10 weeks (including 6 weeks follow up)
The primary outcome measure is 24hr total stool output volume over the double-blind treatment period compared to baseline.
次要结局
- To assess change from Baseline in Quality of Life(10 weeks (including 6 weeks follow up))
- To assess the change from baseline in Patient Global Impression(10 weeks (including 6 weeks follow up))
- Assess the safety and tolerability of vurolenatide(10 weeks (including 6 weeks follow up))
研究者
研究点 (1)
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