AGN-151607-DP to help close the belly wall after open midline 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
This trial tests whether a single intramuscular dose of AGN-151607-DP helps safely close the belly wall in adults having open midline ventral hernia repair.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 6 sites (Riverside, California and 5 other locations) |
| Trial ID | NCT07226791 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized, placebo-controlled trial will enroll about 200 adults undergoing open midline ventral hernia repair across roughly 30 U.S. sites. Participants are randomly assigned to receive a single intramuscular injection of AGN-151607-DP or matching placebo on Day 1, and are followed for adverse events and change in disease activity related to fascial closure. The study specifically examines whether the drug can enable primary fascial closure without requiring more complex surgical techniques. Total study duration for participants is approximately 25 months with scheduled follow-up visits.
Who should consider this trial
Good fit: Adults with a midline ventral hernia who require open surgical repair and who do not have excluded neuromuscular conditions or recent abdominal/hernia surgery are the intended candidates.
Not a fit: People with diagnosed neuromuscular disorders (for example Duchenne muscular dystrophy, myasthenia gravis, ALS, mitochondrial disease) or those who had abdominal or hernia repair within the prior 6 months are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, the drug could make primary fascial closure safer and reduce the need for more complex repair techniques.
How similar studies have performed: This approach is relatively novel, with limited prior clinical evidence for intramuscular pharmacologic agents specifically used to aid fascial closure in ventral hernia repair.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Riverside, California and 5 other locations
- CARI Clinical Trials INC /ID# 278844 — Riverside, California, United States (Recruiting)
- University of Florida - Jacksonville /ID# 261992 — Jacksonville, Florida, United States (Recruiting)
- Medical Research Center /ID# 278680 — Miami, Florida, United States (Recruiting)
- NorthShore University-Endeavor Health Evanston Hospital /ID# 277995 — Evanston, Illinois, United States (Recruiting)
- Novant Health New Hanover Regional Medical Center /ID# 261979 — Wilmington, North Carolina, United States (Recruiting)
- NextStage Clinical Research-Evergreen Surgical /ID# 278710 — Eau Claire, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.