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Recruiting NCT07226791

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

Phase II Interventional Ventral Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AGN-151607-DP, Placebo for AGN-151607-DP.
Who it may be relevant to
Registry conditions: Ventral Hernia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair [Time frame: Up to approximately 1 Month]
  • Percentage of Participants Experiencing Adverse Events [Time frame: Up to approximately 25 Months]
Secondary outcome measures (7)
  • Percentage of Participants Achieving PFC [Time frame: Up to approximately 1 Month]
  • Percentage of Participants With Usage of CST for the Purpose of PFC [Time frame: Up to approximately 1 Month]
  • Number of Lateral Abdominal Wall Muscles Released to Achieve PFC [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Up to approximately 1 Month]

Eligibility criteria

Inclusion criteria

\- Midline ventral hernia requiring open surgical repair.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • 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
  • … and 4 more centers

Identifiers

NCT: NCT07226791 · M24-846

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗