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NCT05248893

PHASE3

A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with botulinum toxin. The primary purpose of this study is to evaluate the safety of AGN-151586 over up to three 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 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 doses 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.

Official title: A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

992

Start Date

2022-02-25

Completion Date

2023-06-26

Last Updated

2026-09-25

Healthy Volunteers

Conditions

Glabellar Lines

Interventions

DRUG

AGN-151586

Powder for Solution for Intramuscular Injection

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 subject 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 toxin 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 screening 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 (SARSCoV-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).

Locations (43)

Skin Wellness Dermatology - Homewood /ID# 241233

Birmingham, Alabama, United States

Advanced Research Associates - Glendale /ID# 232245

Glendale, Arizona, United States

Skin Care and Laser Physicians of Beverly Hills /ID# 241237

Los Angeles, California, United States

The Eye Research Foundation /ID# 232229

Newport Beach, California, United States

Cosmetic Laser Dermatology /ID# 243513

San Diego, California, United States

UC San Diego Health - University Center Lane - La Jolla /ID# 241243

San Diego, California, United States

Ava T. Shamban MD - Santa Monica. /ID# 241246

Santa Monica, California, United States

Art of Skin MD /ID# 241244

Solana Beach, California, United States

Moradi MD /ID# 241242

Vista, California, United States

AboutSkin Research, LLC /ID# 241702

Greenwood Village, Colorado, United States

Susan H. Weinkle MD /ID# 233835

Bradenton, Florida, United States

Skin Research Institute LLC /ID# 232240

Coral Gables, Florida, United States

Skin and Cancer Associates, LLP /ID# 232228

Miami, Florida, United States

ForCare Clinical Research /ID# 241229

Tampa, Florida, United States

Hamilton Research, LLC /ID# 241232

Alpharetta, Georgia, United States

Atlanta Biomedical Clinical Research /ID# 241258

Atlanta, Georgia, United States

Meridian Clinical Research Dermatology /ID# 241234

Savannah, Georgia, United States

DeNova Research /ID# 232231

Chicago, Illinois, United States

Advanced Dermatology /ID# 241252

Lincolnshire, Illinois, United States

Laser and Skin Surgery Center of Indiana /ID# 233834

Indianapolis, Indiana, United States

Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230

Metairie, Louisiana, United States

Etre Cosmetic Dermatology and Laser Center /ID# 232235

New Orleans, Louisiana, United States

Visage Dermatology and Aesthetic Center /ID# 241248

Largo, Maryland, United States

Rkmd, Llc /Id# 241239

North Bethesda, Maryland, United States

Michigan Center for Research Company /ID# 241255

Clarkston, Michigan, United States

Rao Dermatology /ID# 243515

Atlantic Highlands, New Jersey, United States

image Dermatology, P.C. /ID# 241227

Montclair, New Jersey, United States

The Rejuva Center /ID# 244285

Latham, New York, United States

Mariwalla Dermatology /ID# 241240

West Islip, New York, United States

Northwest Dermatology Institute /ID# 233498

Portland, Oregon, United States

Perelman Center for Advanced Medicine - /ID# 243966

Philadelphia, Pennsylvania, United States

Sherman Aesthetic Center /ID# 241247

Nashville, Tennessee, United States

Tennessee Clinical Research Center /ID# 241254

Nashville, Tennessee, United States

DermResearch, Inc. Austin, TX /ID# 241228

Austin, Texas, United States

Bellaire Dermatology Associates /ID# 232243

Bellaire, Texas, United States

J&S Studies, Inc. /ID# 241236

College Station, Texas, United States

Dallas Center for Dermatology and Aesthetics /ID# 241245

Dallas, Texas, United States

Swinyer-Woseth Dermatology /ID# 241250

Salt Lake City, Utah, United States

The Education & Research Foundation, Inc. /ID# 241225

Lynchburg, Virginia, United States

Premier Clinical Research /ID# 233836

Spokane, Washington, United States

EthiQ2 Research, LLC /ID# 241256

Brookfield, Wisconsin, United States

Santa Cruz Behavioral (SCB) Research Center /ID# 241226

Bayamón, Puerto Rico

Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241

San Juan, Puerto Rico