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

Résumé

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.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair

   PFC will be defined as the ability to achieve fascia to fascia midline approximation.

   Délai Up to approximately 1 Month

2. Critère de jugement principal

   Percentage of Participants Experiencing Adverse Events

   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.

   Délai Up to approximately 25 Months

3. Critère de jugement secondaire

   Percentage of Participants Achieving PFC

   PFC will be defined as the ability to achieve fascia to fascia midline approximation.

   Délai Up to approximately 1 Month

4. Critère de jugement secondaire

   Percentage of Participants With Usage of CST for the Purpose of PFC

   Percentage of participants with usage of CST will be assessed.

   Délai Up to approximately 1 Month

5. Critère de jugement secondaire

   Number of Lateral Abdominal Wall Muscles Released to Achieve PFC

   Number of lateral abdominal wall muscles released to achieve PFC will be assessed.

   Délai Up to approximately 1 Month

6. Critère de jugement secondaire

   Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair

   Change in length of lateral abdominal wall complex will be assessed.

   Délai Up to approximately 1 Month

7. Critère de jugement secondaire

   Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair

   Change in length of lateral abdominal wall complex will be assessed.

   Délai Up to approximately 1 Month

8. Critère de jugement secondaire

   Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair

   Change in width to the hernia defect will be assessed.

   Délai Up to approximately 1 Month

9. Critère de jugement secondaire

   Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair

   Change in width to the hernia defect will be assessed.

   Délai Up to approximately 1 Month

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

11 sites sont en recrutement

Documents de l'étude

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Évolution au fil du temps

1. 25 août 2026

   Site ajouté

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