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

AbbVie

Status and phase: Begins enrollment this month; Phase 2

Conditions: Ventral Hernia

Treatments: Drug: Placebo for AGN-151607-DP; Drug: AGN-151607-DP

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226791

M24-846

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

AGN-151607-DP Dose A

Experimental group

Description:

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

Treatment:

Drug: AGN-151607-DP

AGN-151607-DP Dose B

Experimental group

Description:

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

Treatment:

Drug: AGN-151607-DP

AGN-151607-DP Dose C

Experimental group

Description:

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

Treatment:

Drug: AGN-151607-DP

Placebo for AGN-151607-DP

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for AGN-151607-DP