A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines

  • STATUS
    Recruiting
  • End date
    Mar 21, 2023
  • participants needed
    600
  • sponsor
    Allergan
Updated on 28 October 2022

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 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 600 adult participants with moderate to severe GL will be enrolled in the study in approximately 38 sites across the world.

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.

Details
Condition Glabellar Lines
Treatment Placebo, AGN-151586
Clinical Study IdentifierNCT05248867
SponsorAllergan
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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
Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to Baseline (Day 1 of treatment) and for therapeutic treatment within the last 12 months prior to study drug administration
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 or 5 half-lives of the drug (whichever is longer) 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)
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