Phase 2 Study of AGN-151607-DP to Test Safety and Effectiveness for Closing the Belly Wall After Open Ventral Hernia Surgery Without Complex Techniques

What this Trial Is About

This trial investigates the use of AGN-151607-DP, an investigational drug, for adults with midline ventral hernia undergoing open surgical repair. The study aims to assess whether this drug is safe and effective for closing the belly wall without needing a complex surgical procedure called the component separation technique. Researchers will evaluate adverse events and changes in disease activity to better understand the treatments impact. Participants will be randomly assigned to receive one of three doses of AGN-151607-DP or a matching placebo. Each participant will get a single intramuscular injection of the assigned dose on Day 1 of the study. The trial is designed with a sequential dose-escalation approach and will take place at about 30 sites in the United States. During the approximately 25-month study period, participants will attend regular weekly visits at a hospital or clinic. Medical assessments, blood tests, and questionnaires will be used to monitor the effects of the treatment and check for side effects. The main outcomes measured include the percentage of participants achieving primary fascial closure without the complex technique and the occurrence of adverse events.

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