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
1 other identifier
interventional
200
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
November 10, 2025
CompletedStudy Start
First participant enrolled
February 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
April 2, 2026
March 1, 2026
2.6 years
November 7, 2025
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Percentage of Participants Achieving PFC
Up to approximately 1 Month
Percentage of Participants With Usage of CST for the Purpose of PFC
Up to approximately 1 Month
Number of Lateral Abdominal Wall Muscles Released to Achieve PFC
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
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
Up to approximately 1 Month
- +2 more secondary outcomes
Study Arms (4)
AGN-151607-DP Dose A
EXPERIMENTALParticipants will receive AGN-151607-DP Dose A on Day 1.
AGN-151607-DP Dose B
EXPERIMENTALParticipants will receive AGN-151607-DP Dose B on Day 1.
AGN-151607-DP Dose C
EXPERIMENTALParticipants will receive AGN-151607-DP Dose C on Day 1.
Placebo for AGN-151607-DP
PLACEBO COMPARATORParticipants will receive Placebo for AGN-151607-DP on Day 1.
Interventions
Intramuscular Injection
Eligibility Criteria
You may qualify if:
- \- Midline ventral hernia requiring open surgical repair.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (3)
University of Florida - Jacksonville /ID# 261992
Jacksonville, Florida, 32209, United States
Medical Research Center /ID# 278680
Miami, Florida, 33144, United States
NextStage Clinical Research-Evergreen Surgical /ID# 278710
Eau Claire, Wisconsin, 54701, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2025
First Posted
November 10, 2025
Study Start
February 4, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
May 1, 2030
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.