Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- CatalYm GmbH
- 入组人数
- 518
- 试验地点
- 73
- 主要终点
- Change from baseline in appetite at 12 weeks
研究概览
简要总结
A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are:
- Does visugromab help participants put weight back on and have a better appetite?
- Does visugromab help participants move more and better?
- What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug).
Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight loss
- •Advanced cancer
排除标准
- •Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product
研究组 & 干预措施
Visugromab low dose
干预措施: Visugromab (CTL-002) (Drug)
Visugromab medium dose
干预措施: Visugromab (CTL-002) (Drug)
Placebo
干预措施: Placebo (Drug)
Visugromab high dose
干预措施: Visugromab (CTL-002) (Drug)
结局指标
主要结局
Change from baseline in appetite at 12 weeks
时间窗: 12 weeks
Measured on the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy instrument (minimum score 0, maximum 20; higher is better outcome)
Change from baseline in body weight at 12 weeks
时间窗: 12 weeks
Change from baseline in body weight at 12 weeks
时间窗: 12 weeks
Change from baseline in appetite at 12 weeks
时间窗: 12 weeks
Measured on the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy instrument (minimum score 0, maximum 20; higher is better outcome)
次要结局
未报告次要终点