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NCT07756580PHASE1Recruiting

A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines

AbbVie

Start Date

8/10/2026

Completion Date

3/1/2027

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 assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL. AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States. Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits * Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters * Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator. Exclusion Criteria: * Severe glabellar lines at rest as assessed by the investigator using the FWS * Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening * History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug

Interventions

DRUG

AGN-151586

DRUG

BOTOX

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Conditions

Glabellar Lines

Locations

Advanced Research Associates - Glendale /ID# 283833

Glendale, Arizona 85308

United States

Eye Research Foundation /ID# 283835

Newport Beach, California 92663

United States

Pacific Clinical Innovations /ID# 283812

Vista, California 92083

United States

Etre, Cosmetic Dermatology And Laser Center /ID# 283831

New Orleans, Louisiana 70130

United States

Skincare Physicians /ID# 283851

Chestnut Hill, Massachusetts 02467

United States

Wilmington Dermatology Center /ID# 283853

Wilmington, North Carolina 28403

United States

Tennessee Clinical Research Center /ID# 283894

Nashville, Tennessee 37215

United States

Austin Institute for Clinical Research - Pflugerville /ID# 283817

Pflugerville, Texas 78660

United States