Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair (NCT07226791)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: CARI Clinical Trials INC /ID# 278844 — Riverside, California
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- CARI Clinical Trials INC /ID# 278844 — Riverside, California
- University of Florida - Jacksonville /ID# 261992 — Jacksonville, Florida
- Medical Research Center /ID# 278680 — Miami, Florida
- Avanza Medical Research Center /ID# 278885 — Pensacola, Florida
- NorthShore University-Endeavor Health Evanston Hospital /ID# 277995 — Evanston, Illinois
- Integrity Clinical Research /ID# 278710 — Wichita, Kansas
- Mayo Clinic Hospital Rochester /ID# 278995 — Rochester, Minnesota
- Novant Health New Hanover Regional Medical Center /ID# 261979 — Wilmington, North Carolina
- Cleveland Clinic - Cleveland /ID# 277914 — Cleveland, Ohio
- Penn State Milton S. Hershey Medical Center /ID# 261987 — Hershey, Pennsylvania
- Prisma Health Greenville Memorial Hospital /ID# 261995 — Greenville, South Carolina
- Baylor University Medical Center /ID# 261955 — Dallas, Texas
- Carilion Roanoke Memorial Hospital /ID# 278577 — Roanoke, Virginia
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ventral Hernia
- CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs — Jacksonville, Florida
- AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair — Weston, Florida
- Methocarbamol in Ventral and Inguinal HR — Greenville, South Carolina
- The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery — Philadelphia, Pennsylvania
- Robotic Versus Open Ventral Hernia Repair — Gainesville, Florida
Explore by condition: All Ventral Hernia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.