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

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 Overview

• Status: Recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Drug: AGN-151607-DP; Drug: Placebo for AGN-151607-DP

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • California
    • Riverside, California, United States, 92504
      • Recruiting
      • CARI Clinical Trials INC /ID# 278844
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Recruiting
      • University of Florida - Jacksonville /ID# 261992
    • Miami, Florida, United States, 33144
      • Recruiting
      • Medical Research Center /ID# 278680
    • Pensacola, Florida, United States, 32503
      • Recruiting
      • Avanza Medical Research Center /ID# 278885
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University-Endeavor Health Evanston Hospital /ID# 277995
  • Kansas
    • Wichita, Kansas, United States, 67202
      • Completed
      • Integrity Clinical Research /ID# 278710
  • North Carolina
    • Wilmington, North Carolina, United States, 28401-7407
      • Recruiting
      • Novant Health New Hanover Regional Medical Center /ID# 261979
      • Contact: Site Coordinator; Phone Number: 910-465-6679
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic - Cleveland /ID# 277914
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor University Medical Center /ID# 261955

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair	PFC will be defined as the ability to achieve fascia to fascia midline approximation.	Up to approximately 1 Month
Percentage of Participants Experiencing Adverse Events	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 25 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving PFC	PFC will be defined as the ability to achieve fascia to fascia midline approximation.	Up to approximately 1 Month
Percentage of Participants With Usage of CST for the Purpose of PFC	Percentage of participants with usage of CST will be assessed.	Up to approximately 1 Month
Number of Lateral Abdominal Wall Muscles Released to Achieve PFC	Number of lateral abdominal wall muscles released to achieve PFC will be assessed.	Up to approximately 1 Month
Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair	Change in length of lateral abdominal wall complex will be assessed.	Up to approximately 1 Month
Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair	Change in length of lateral abdominal wall complex will be assessed.	Up to approximately 1 Month
Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair	Change in width to the hernia defect will be assessed.	Up to approximately 1 Month
Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair	Change in width to the hernia defect will be assessed.	Up to approximately 1 Month

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: November 7, 2025
• First Submitted That Met QC Criteria: November 7, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ventral Hernia; Primary fascial closure; AGN-151607-DP; Open Abdominal Ventral Hernia Repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Ventral
• Other Study ID Numbers: M24-846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes