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

Completed · Phase 3 · Has a placebo group

Conditions studied: Glabellar Lines

In brief

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.

Key facts

Study ID: NCT05248880
Run by: AbbVie
People needed: 309
Starts: 2022-03-08
Expected to finish: 2023-02-01
Last updated by the study team: 2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

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

Full record on ClinicalTrials.gov

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