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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in toxin-naïve participants with moderate to severe GL. This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
309
Intramuscular Injection
Intramuscular Injection
Clear Dermatology & Aesthetics Center /ID# 238990
Scottsdale, Arizona, United States
Steve Yoelin MD Medical Assoc. Inc /ID# 243197
Newport Beach, California, United States
Marcus Facial Plastic Surgery /ID# 241703
Redondo Beach, California, United States
DMR Research PLLC /ID# 239061
Westport, Connecticut, United States
Kavali Plastic Surgery /ID# 244808
Atlanta, Georgia, United States
Delricht Research - 10154 Jefferson /ID# 244890
Baton Rouge, Louisiana, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067
Hunt Valley, Maryland, United States
Wilmington Dermatology Center /ID# 233935
Wilmington, North Carolina, United States
Clinical Research Center of the Carolinas /ID# 239064
Charleston, South Carolina, United States
Austin Institute for Clinical Research /ID# 238989
Pflugerville, Texas, United States
...and 7 more locations
Percentage of participants with ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments (composite) of Glabellar Lines (GL) severity at maximum frown
The investigator and participant assessments of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
Time frame: Day 7
Number of Participants with Adverse Events
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: Up to 12 Weeks
Change from baseline in Vital Sign Measurements
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time frame: Up to 12 Weeks
Change from baseline in ECG parameters
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: Up to 12 Weeks
Change from baseline in laboratory evaluations
Percentage of participants with abnormal clinical laboratory values like hematology and chemistry will be assessed.
Time frame: Up to 12 Weeks
Presence of binding and neutralizing antidrug antibodies
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.
Time frame: Up to 12 Weeks
Percentage of participants with ≥ 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown over the double-blind period
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
Time frame: Up to 6 Weeks
Percentage of participants with ≥ 2-grade improvement from baseline on the FWS according to participant assessment of GL severity at maximum frown over the double-blind period
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
Time frame: Up to 6 Weeks
Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Item 5 (overall satisfaction) for GL
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Time frame: Day 7
Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 5 (overall satisfaction) for GL
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Time frame: Hour 24
Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 4 (natural look) for GL
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Time frame: Day 7
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