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

Part of paid clinical trials in Riverside, California.

Sponsor
AbbVie
Study ID
NCT07226791
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Ventral Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AGN-151607-DP — DRUG
    Intramuscular Injection
  • Placebo for AGN-151607-DP — DRUG
    Intramuscular Injection

Study Details

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.

Key Dates

Start date
Feb 4, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
May 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AGN-151607-DP Dose A
    Participants will receive AGN-151607-DP Dose A on Day 1.
  • Experimental: AGN-151607-DP Dose B
    Participants will receive AGN-151607-DP Dose B on Day 1.
  • Experimental: AGN-151607-DP Dose C
    Participants will receive AGN-151607-DP Dose C on Day 1.
  • Placebo Comparator: Placebo for AGN-151607-DP
    Participants will receive Placebo for AGN-151607-DP on Day 1.

Primary Outcome Measure

Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair [ Time Frame: Up to approximately 1 Month ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
CARI Clinical Trials INC /ID# 278844RiversideCalifornia92504-
University of Florida - Jacksonville /ID# 261992JacksonvilleFlorida32209-
Medical Research Center /ID# 278680MiamiFlorida33144-
Avanza Medical Research Center /ID# 278885PensacolaFlorida32503-
NorthShore University-Endeavor Health Evanston Hospital /ID# 277995EvanstonIllinois60201-
Integrity Clinical Research /ID# 278710WichitaKansas67202-
Novant Health New Hanover Regional Medical Center /ID# 261979WilmingtonNorth Carolina28401-7407
Site Coordinator
910-465-6679
Cleveland Clinic - Cleveland /ID# 277914ClevelandOhio44195-
Prisma Health Greenville Memorial Hospital /ID# 261995GreenvilleSouth Carolina29605-4210-
Baylor University Medical Center /ID# 261955DallasTexas75246-
Carilion Roanoke Memorial Hospital /ID# 278577RoanokeVirginia24014-

Find similar trials in Riverside, CA

By research site
CARI Clinical Trials INC· Riverside, CAUniversity of Florida - Jacksonville· Jacksonville, FLMedical Research Center· Miami, FLAvanza Medical Research Center· Pensacola, FLNorthShore University-Endeavor Health Evanston Hospital· Evanston, ILIntegrity Clinical Research· Wichita, KS

Related Studies