Clinical trial NCT05248880: A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Keywords: Glabellar Lines
AGN-151586
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: Day 7
measure: Number of Participants with Adverse Events
timeFrame: Up to 12 Weeks
measure: Change from baseline in Vital Sign Measurements
timeFrame: Up to 12 Weeks
measure: Change from baseline in ECG parameters
timeFrame: Up to 12 Weeks
measure: Change from baseline in laboratory evaluations
timeFrame: Up to 12 Weeks
measure: Presence of binding and neutralizing antidrug antibodies
timeFrame: Up to 12 Weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 6 Weeks
measure: 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
timeFrame: Up to 6 Weeks
measure: Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Item 5 (overall satisfaction) for GL
timeFrame: Day 7
measure: Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 5 (overall satisfaction) for GL
timeFrame: Hour 24
measure: Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 4 (natural look) for GL
timeFrame: Day 7
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center /ID# 238990
state: Arizona
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Assoc. Inc /ID# 243197
state: California
city: Redondo Beach
country: United States
facility: Marcus Facial Plastic Surgery /ID# 241703
state: California
city: Westport
country: United States
facility: DMR Research PLLC /ID# 239061
state: Connecticut
city: Atlanta
country: United States
facility: Kavali Plastic Surgery /ID# 244808
state: Georgia
city: Baton Rouge
country: United States
facility: Delricht Research - 10154 Jefferson /ID# 244890
state: Louisiana
city: Hunt Valley
country: United States
facility: Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067
state: Maryland
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 233935
state: North Carolina
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas /ID# 239064
state: South Carolina
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 238989
state: Texas
city: West Valley City
country: United States
facility: Kalo Clinical Research /ID# 247279
state: Utah
city: Arlington
country: United States
facility: SkinDC /ID# 238988
state: Virginia
city: Vancouver
country: Canada
facility: YVR Aesthetics Training & Study Centre /ID# 241858
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm /ID# 239654
state: British Columbia
city: Cobourg
country: Canada
facility: Dr Melinda Gooderham Medicine Profession /ID# 239657
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials /ID# 245873
state: Ontario
city: Laval
country: Canada
facility: Clinique D /ID# 239653
state: Quebec
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: