Clinical trial NCT05248893: A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
Official title: A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Keywords: Glabellar Lines
AGN-151586
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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. The purpose of this study is to evaluate the safety of AGN-151586 over multiple repeat 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, 126 day 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 cycles 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.


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.
* 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).

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Day 1 to Day 126
measure: Change in Vital Sign Measurements
timeFrame: Day 1 to Day 126
measure: Change in Electrocardiogram (ECG) Measurements
timeFrame: Day 1 to Day 126
measure: Presence of binding and neutralizing antidrug antibodies
timeFrame: Day 1 to Day 126
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Skin Wellness Dermatology - Homewood /ID# 241233
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 232245
state: Arizona
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills /ID# 241237
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 232229
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 243513
state: California
city: San Diego
country: United States
facility: UC San Diego Health - University Center Lane - La Jolla /ID# 241243
state: California
city: Santa Monica
country: United States
facility: Ava T. Shamban MD - Santa Monica. /ID# 241246
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD /ID# 241244
state: California
city: Vista
country: United States
facility: Moradi MD /ID# 241242
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC /ID# 241702
state: Colorado
city: Bradenton
country: United States
facility: Susan H. Weinkle MD /ID# 233835
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 232240
state: Florida
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 232228
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 241229
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC /ID# 241232
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Biomedical Clinical Research /ID# 241258
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research Dermatology /ID# 241234
state: Georgia
city: Chicago
country: United States
facility: DeNova Research /ID# 232231
state: Illinois
city: Lincolnshire
country: United States
facility: Advanced Dermatology /ID# 241252
state: Illinois
city: Indianapolis
country: United States
facility: Laser and Skin Surgery Center of Indiana /ID# 233834
state: Indiana
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230
state: Louisiana
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center /ID# 232235
state: Louisiana
city: Largo
country: United States
facility: Visage Dermatology and Aesthetic Center /ID# 241248
state: Maryland
city: North Bethesda
country: United States
facility: Rkmd, Llc /Id# 241239
state: Maryland
city: Clarkston
country: United States
facility: Michigan Center for Research Company /ID# 241255
state: Michigan
city: Atlantic Highlands
country: United States
facility: Rao Dermatology /ID# 243515
state: New Jersey
city: Montclair
country: United States
facility: image Dermatology, P.C. /ID# 241227
state: New Jersey
city: Latham
country: United States
facility: The Rejuva Center /ID# 244285
state: New York
city: West Islip
country: United States
facility: Mariwalla Dermatology /ID# 241240
state: New York
city: Portland
country: United States
facility: Northwest Dermatology Institute /ID# 233498
state: Oregon
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine - /ID# 243966
state: Pennsylvania
city: Nashville
country: United States
facility: Sherman Aesthetic Center /ID# 241247
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center /ID# 241254
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc. Austin, TX /ID# 241228
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 232243
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc. /ID# 241236
state: Texas
city: Dallas
country: United States
facility: Dallas Center for Dermatology and Aesthetics /ID# 241245
state: Texas
city: Salt Lake City
country: United States
facility: Swinyer-Woseth Dermatology /ID# 241250
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc. /ID# 241225
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 233836
state: Washington
city: Brookfield
country: United States
facility: EthiQ2 Research, LLC /ID# 241256
state: Wisconsin
city: Bayamon
country: Puerto Rico
facility: Santa Cruz Behavioral (SCB) Research Center /ID# 241226
city: San Juan
country: Puerto Rico
facility: Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: