A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines

Glabellar Lines Clinical Trial

Official title:

A Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines in Toxin-Naïve Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248880
• Other study ID #: M21-508
• Status: Completed
• Phase: Phase 3
• Start date: March 8, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2024
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable).
• Participant must have moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline Day 1 visit.

Exclusion Criteria:

• Uncontrolled systemic disease.
• Participants must not have a history of any use of botulinum neurotoxin of any serotype for any indication (including any investigational botulinum neurotoxin product).
• Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or interfere with the study

evaluation, including:

• Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
• History of facial nerve palsy
• Infection or dermatological condition at the treatment injection sites
• Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
• Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator
• History of known immunization to any botulinum neurotoxin serotype.
• Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
• Anticipated need for surgery or overnight hospitalization during the study.
• History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
• History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
• Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
• Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
• Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
• Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• AGN-151586
Intramuscular Injection
• Placebo
Intramuscular Injection

Locations

Country	Name	City	State
Canada	Dr Melinda Gooderham Medicine Profession /ID# 239657	Cobourg	Ontario
Canada	Clinique D /ID# 239653	Laval	Quebec
Canada	The Centre for Clinical Trials /ID# 245873	Oakville	Ontario
Canada	Pacific Derm /ID# 239654	Vancouver	British Columbia
Canada	YVR Aesthetics Training & Study Centre /ID# 241858	Vancouver	British Columbia
United States	SkinDC /ID# 238988	Arlington	Virginia
United States	Kavali Plastic Surgery /ID# 244808	Atlanta	Georgia
United States	Delricht Research - 10154 Jefferson /ID# 244890	Baton Rouge	Louisiana
United States	Clinical Research Center of the Carolinas /ID# 239064	Charleston	South Carolina
United States	Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067	Hunt Valley	Maryland
United States	Steve Yoelin MD Medical Assoc. Inc /ID# 243197	Newport Beach	California
United States	Austin Institute for Clinical Research /ID# 238989	Pflugerville	Texas
United States	Marcus Facial Plastic Surgery /ID# 241703	Redondo Beach	California
United States	Clear Dermatology & Aesthetics Center /ID# 238990	Scottsdale	Arizona
United States	Kalo Clinical Research /ID# 247279	West Valley City	Utah
United States	DMR Research PLLC /ID# 239061	Westport	Connecticut
United States	Wilmington Dermatology Center /ID# 233935	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7
Primary	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.	Up to 12 Weeks
Primary	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.	Up to 12 Weeks
Primary	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).	Up to 12 Weeks
Primary	Change from baseline in laboratory evaluations	Percentage of participants with abnormal clinical laboratory values like hematology and chemistry will be assessed.	Up to 12 Weeks
Primary	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.	Up to 12 Weeks
Secondary	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.	Up to 6 Weeks
Secondary	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.	Up to 6 Weeks
Secondary	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.	Day 7
Secondary	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.	Hour 24
Secondary	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.	Day 7