A Phase 2 Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair
研究概览
简要总结
A ventral hernia happens when the muscles in the front of your belly become weak and let organs push through, causing a bulge. If it gets worse, intestines can slip into the bulge, leading to serious pain and health problems. This study aims to asses if AGN-151607-DP is safe and effective for closing the belly wall after open ventral hernia surgery, without needing a complex procedure. Adverse Events and change in disease activity will be assessed.
AGN-151607-DP is an investigational drug being developed to treat ventral hernia. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 200 adult participants with midline ventral hernia needing open surgical repair will be enrolled in approximately 30 sites in the United States.
Participants will receive intramuscular injections of AGN-161607-DP or matching placebo on Day 1. Duration of the study is approximately 25 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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)
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
- •- Midline ventral hernia requiring open surgical repair.
排除标准
- •Medical condition that may put the participant at increased risk with exposure to AGN-151607-DP, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function.
- •History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening.
研究组 & 干预措施
AGN-151607-DP Dose B
Participants will receive AGN-151607-DP Dose B on Day 1.
干预措施: AGN-151607-DP (Drug)
AGN-151607-DP Dose A
Participants will receive AGN-151607-DP Dose A on Day 1.
干预措施: AGN-151607-DP (Drug)
AGN-151607-DP Dose C
Participants will receive AGN-151607-DP Dose C on Day 1.
干预措施: AGN-151607-DP (Drug)
Placebo for AGN-151607-DP
Participants will receive Placebo for AGN-151607-DP on Day 1.
干预措施: Placebo for AGN-151607-DP (Drug)
结局指标
主要结局
Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair
时间窗: Up to approximately 1 Month
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Percentage of Participants Experiencing Adverse Events
时间窗: Up to approximately 25 Months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Percentage of Participants Achieving PFC(Up to approximately 1 Month)
- Percentage of Participants With Usage of CST for the Purpose of PFC(Up to approximately 1 Month)
- Number of Lateral Abdominal Wall Muscles Released to Achieve PFC(Up to approximately 1 Month)
- Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair(Up to approximately 1 Month)
- Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair(Up to approximately 1 Month)
- Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair(Up to approximately 1 Month)
- Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair(Up to approximately 1 Month)