A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines
1 other identifier
interventional
986
2 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2022
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2023
CompletedMay 29, 2024
May 1, 2024
1.3 years
February 14, 2022
May 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Day 1 to Day 126
Change in Vital Sign Measurements
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Day 1 to Day 126
Change in Electrocardiogram (ECG) Measurements
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Day 1 to Day 126
Presence of binding and neutralizing antidrug antibodies
Blood samples for immunogenicity testing will be collected from all participants treated with AGN-151586 at predetermined timepoints. Collected samples will be processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.
Day 1 to Day 126
Study Arms (1)
AGN-151586
EXPERIMENTALParticipants will receive 5 intramuscular injections in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may receive up to 2 additional cycles of open-label treatments.
Interventions
Eligibility Criteria
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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (43)
Skin Wellness Dermatology - Homewood /ID# 241233
Birmingham, Alabama, 35209-8314, United States
Advanced Research Associates - Glendale /ID# 232245
Glendale, Arizona, 85308, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 241237
Los Angeles, California, 90069, United States
The Eye Research Foundation /ID# 232229
Newport Beach, California, 92663-3637, United States
Cosmetic Laser Dermatology /ID# 243513
San Diego, California, 92121-2119, United States
UC San Diego Health - University Center Lane - La Jolla /ID# 241243
San Diego, California, 92122-1013, United States
Ava T. Shamban MD - Santa Monica. /ID# 241246
Santa Monica, California, 90404-2208, United States
Art of Skin MD /ID# 241244
Solana Beach, California, 92075-2228, United States
Moradi MD /ID# 241242
Vista, California, 92083-6030, United States
AboutSkin Research, LLC /ID# 241702
Greenwood Village, Colorado, 80111, United States
Susan H. Weinkle MD /ID# 233835
Bradenton, Florida, 34209-5642, United States
Skin Research Institute LLC /ID# 232240
Coral Gables, Florida, 33146-1837, United States
Skin and Cancer Associates, LLP /ID# 232228
Miami, Florida, 33137-3254, United States
ForCare Clinical Research /ID# 241229
Tampa, Florida, 33613-1244, United States
Hamilton Research, LLC /ID# 241232
Alpharetta, Georgia, 30022, United States
Atlanta Biomedical Clinical Research /ID# 241258
Atlanta, Georgia, 30331-2160, United States
Meridian Clinical Research Dermatology /ID# 241234
Savannah, Georgia, 31406-2632, United States
DeNova Research /ID# 232231
Chicago, Illinois, 60611, United States
Advanced Dermatology /ID# 241252
Lincolnshire, Illinois, 60069, United States
Laser and Skin Surgery Center of Indiana /ID# 233834
Indianapolis, Indiana, 46260-2386, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230
Metairie, Louisiana, 70006, United States
Etre Cosmetic Dermatology and Laser Center /ID# 232235
New Orleans, Louisiana, 70130-4353, United States
Visage Dermatology and Aesthetic Center /ID# 241248
Largo, Maryland, 20774-5341, United States
Rkmd, Llc /Id# 241239
North Bethesda, Maryland, 20852-3093, United States
Michigan Center for Research Company /ID# 241255
Clarkston, Michigan, 48346, United States
Rao Dermatology /ID# 243515
Atlantic Highlands, New Jersey, 07716-1241, United States
image Dermatology, P.C. /ID# 241227
Montclair, New Jersey, 07042, United States
The Rejuva Center /ID# 244285
Latham, New York, 12110, United States
Mariwalla Dermatology /ID# 241240
West Islip, New York, 11795-4916, United States
Northwest Dermatology Institute /ID# 233498
Portland, Oregon, 97210-2859, United States
Perelman Center for Advanced Medicine - /ID# 243966
Philadelphia, Pennsylvania, 19104-5127, United States
Sherman Aesthetic Center /ID# 241247
Nashville, Tennessee, 37205-2205, United States
Tennessee Clinical Research Center /ID# 241254
Nashville, Tennessee, 37215-2885, United States
DermResearch, Inc. Austin, TX /ID# 241228
Austin, Texas, 78759, United States
Bellaire Dermatology Associates /ID# 232243
Bellaire, Texas, 77401, United States
J&S Studies, Inc. /ID# 241236
College Station, Texas, 77845-3898, United States
Dallas Center for Dermatology and Aesthetics /ID# 241245
Dallas, Texas, 75225-6203, United States
Swinyer-Woseth Dermatology /ID# 241250
Salt Lake City, Utah, 84117-4209, United States
The Education & Research Foundation, Inc. /ID# 241225
Lynchburg, Virginia, 24501-1403, United States
Premier Clinical Research /ID# 233836
Spokane, Washington, 99202, United States
EthiQ2 Research, LLC /ID# 241256
Brookfield, Wisconsin, 53005, United States
Santa Cruz Behavioral (SCB) Research Center /ID# 241226
Bayamón, 00961-6910, Puerto Rico
Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241
San Juan, 00917, Puerto Rico
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2022
First Posted
February 21, 2022
Study Start
February 25, 2022
Primary Completion
June 26, 2023
Study Completion
June 26, 2023
Last Updated
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.