NCT05248893

A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 986 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines. AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States. This is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment during the study. Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

Conditions

• Glabellar Lines

Interventions

Type	Name	Description
DRUG	AGN-151586	Intramuscular Injection

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2022-02-21
• Last updated: 2024-05-29

Locations

43 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study