AGN-151586
DrugIntramuscular Injection
NCT Number: NCT05248893
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Santa Cruz Behavioral (SCB) Research Center /ID# 241226, Bayamón, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular Injection
Time frame: Day 1 to Day 126
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Day 1 to Day 126
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time frame: Day 1 to Day 126
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Time frame: Day 1 to Day 126
Blood samples for immunogenicity testing will be collected from all participants treated with AGN-151586 at predetermined timepoints. Collected samples will be processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.
AbbVie
Industry
A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06308198
Glabellar Lines
Beijing, Beijing Municipality, China
View Trial DetailsNCT05496335
Glabellar Lines
Newport Beach, California, United States
View Trial DetailsNCT07622004
Glabellar Lines
Seoul, South Korea
View Trial DetailsNCT07398755
Glabellar Lines, Midface Volume Deficiency
Vienna, State of Vienna, Austria
View Trial Details