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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2030-05-31

Brief Summary

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A ventral hernia happens when the muscles in the front of your belly become weak and let abdominal content 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.

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Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AGN-151607-DP Dose A

Participants will receive AGN-151607-DP Dose A on Day 1.

Group Type EXPERIMENTAL

AGN-151607-DP

Intervention Type DRUG

Intramuscular Injection

AGN-151607-DP Dose B

Participants will receive AGN-151607-DP Dose B on Day 1.

Group Type EXPERIMENTAL

AGN-151607-DP

Intervention Type DRUG

Intramuscular Injection

AGN-151607-DP Dose C

Participants will receive AGN-151607-DP Dose C on Day 1.

Group Type EXPERIMENTAL

AGN-151607-DP

Intervention Type DRUG

Intramuscular Injection

Placebo for AGN-151607-DP

Participants will receive Placebo for AGN-151607-DP on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo for AGN-151607-DP

Intervention Type DRUG

Intramuscular Injection

Interventions

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AGN-151607-DP

Intramuscular Injection

Intervention Type DRUG

Placebo for AGN-151607-DP

Intramuscular Injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No