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

Study Identifier
M24-846
CT.gov Identifier
NCT07226791
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Hernia
    • Study Drug
  • AGN-151607-DP
  • Placebo for AGN-151607-DP
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    CARI Clinical Trials INC /ID# 278844
    Riverside, California, United States, 92504
    Status
    Recruiting
    Location
    University of Florida - Jacksonville /ID# 261992
    Jacksonville, Florida, United States, 32209
    Status
    Recruiting
    Location
    Medical Research Center /ID# 278680
    Miami, Florida, United States, 33144
    Status
    Recruiting
    Location
    Avanza Medical Research Center /ID# 278885
    Pensacola, Florida, United States, 32503
    Status
    Recruiting
    Location
    NorthShore University-Endeavor Health Evanston Hospital /ID# 277995
    Evanston, Illinois, United States, 60201
    Status
    Recruiting
    Location
    Integrity Clinical Research /ID# 278710
    Wichita, Kansas, United States, 67202
    Status
    Completed
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