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A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines

NCT06308198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2025-03-19

No results posted yet for this study

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 and efficacy of AGN-151586 compared to placebo in adult participants.

AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.

Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular 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.

Conditions

  • Glabellar Lines

Interventions

DRUG

AGN-151586

Intramuscular Injections

DRUG

Placebo

Intramuscular Injections

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2025-02-26
Completion
2025-02-26

Countries

  • China
  • Japan
  • Taiwan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06308198 on ClinicalTrials.gov