RecruitingPhase 2NCT07226791

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

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


Sponsor

AbbVie

Enrollment

200 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AGN-151607-DP and a drug called Placebo for AGN-151607-DP for people with ventral hernia. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAGN-151607-DP

Intramuscular Injection

DRUGPlacebo for AGN-151607-DP

Intramuscular Injection


Locations(13)

CARI Clinical Trials INC /ID# 278844

Riverside, California, United States

University of Florida - Jacksonville /ID# 261992

Jacksonville, Florida, United States

Medical Research Center /ID# 278680

Miami, Florida, United States

Avanza Medical Research Center /ID# 278885

Pensacola, Florida, United States

NorthShore University-Endeavor Health Evanston Hospital /ID# 277995

Evanston, Illinois, United States

Integrity Clinical Research /ID# 278710

Wichita, Kansas, United States

Mayo Clinic Hospital Rochester /ID# 278995

Rochester, Minnesota, United States

Novant Health New Hanover Regional Medical Center /ID# 261979

Wilmington, North Carolina, United States

Cleveland Clinic - Cleveland /ID# 277914

Cleveland, Ohio, United States

Penn State Milton S. Hershey Medical Center /ID# 261987

Hershey, Pennsylvania, United States

Prisma Health Greenville Memorial Hospital /ID# 261995

Greenville, South Carolina, United States

Baylor University Medical Center /ID# 261955

Dallas, Texas, United States

Carilion Roanoke Memorial Hospital /ID# 278577

Roanoke, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07226791


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