NCT04775706招募中2 期
A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Hanmi Pharmaceutical Company Limited24 个研究点 分布在 8 个国家目标入组 18 人开始时间: 2022年3月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 24
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
详细描述
The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years)
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period.
排除标准
- •Any history of colon cancer.
- •History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
- •History of alcohol or drug abuse (within 1 year of screening)
研究组 & 干预措施
HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active
Experimental
干预措施: HM15912 Active (Drug)
Matching Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: for 24 weeks
after multiple subcutaneous (SC) doses
次要结局
未报告次要终点
研究者
研究点 (24)
Loading locations...
相似试验
进行中（未招募）
2 期
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)Alopecia AreataNCT06018428Q32 Bio Inc.75
进行中（未招募）
2 期
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)Atopic DermatitisNCT05509023Q32 Bio Inc.102
终止
2 期
UCB Proof of Concept Study in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeNCT02610543UCB Celltech27
已完成
2 期
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive DisorderMajor Depressive DisorderNCT05376150Xenon Pharmaceuticals Inc.168
Unknown
2 期
A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)Rheumatoid ArthritisNCT03435601Josef Smolen, Univ. Prof. Dr.24