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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AGN-151607-DP Dose A 		Participants will receive AGN-151607-DP Dose A on Day 1.
  • Drug: AGN-151607-DP
    Intramuscular Injection
Experimental
AGN-151607-DP Dose B 		Participants will receive AGN-151607-DP Dose B on Day 1.
  • Drug: AGN-151607-DP
    Intramuscular Injection
Experimental
AGN-151607-DP Dose C 		Participants will receive AGN-151607-DP Dose C on Day 1.
  • Drug: AGN-151607-DP
    Intramuscular Injection
Placebo Comparator
Placebo for AGN-151607-DP 		Participants will receive Placebo for AGN-151607-DP on Day 1.
  • Drug: Placebo for AGN-151607-DP
    Intramuscular Injection

Recruiting Locations

Medical Research Center /ID# 278680
Miami 4164138, Florida 4155751 33144

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.