Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair

Официальное название

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

Обзор

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.

Вмешательства

• Препарат AGN-151607-DP
  Intramuscular Injection
• Препарат Placebo for AGN-151607-DP
  Intramuscular Injection

Первичные конечные точки

• Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair [Срок оценки: Up to approximately 1 Month]
• Percentage of Participants Experiencing Adverse Events [Срок оценки: Up to approximately 25 Months]

Вторичные конечные точки (7)

• Percentage of Participants Achieving PFC [Срок оценки: Up to approximately 1 Month]
• Percentage of Participants With Usage of CST for the Purpose of PFC [Срок оценки: Up to approximately 1 Month]
• Number of Lateral Abdominal Wall Muscles Released to Achieve PFC [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Up to approximately 1 Month]

Критерии участия

Критерии включения

\- Midline ventral hernia requiring open surgical repair.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 12 центров

• CARI Clinical Trials INC /ID# 278844 — Riverside
• University of Florida - Jacksonville /ID# 261992 — Jacksonville
• Medical Research Center /ID# 278680 — Miami
• Avanza Medical Research Center /ID# 278885 — Pensacola
• NorthShore University-Endeavor Health Evanston Hospital /ID# 277995 — Evanston
• Integrity Clinical Research /ID# 278710 — Wichita
• Mayo Clinic Hospital Rochester /ID# 278995 — Rochester
• Novant Health New Hanover Regional Medical Center /ID# 261979 — Wilmington
• … и ещё 4 центра

Идентификаторы

NCT: NCT07226791 · M24-846

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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