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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07226791

Registry updated: 2026-08-25
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Description

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

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

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.

Conditions

Ventral Hernia

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record