Glabellar LinesPhase 3NCT05248893
A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
A Phase 3 study testing AGN-151586 in people with Glabellar Lines, run by AbbVie at 43 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- AGN-151586
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 43 sitesin 2 countries
- Study dates
- 25 Feb 2022to 26 Jun 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States41 sites
Hamilton Research, LLC /ID# 241232
Alpharetta, Georgia, 30022
Atlanta Biomedical Clinical Research /ID# 241258
Atlanta, Georgia, 30331-2160
Rao Dermatology /ID# 243515
Atlantic Highlands, New Jersey, 07716-1241
DermResearch, Inc. Austin, TX /ID# 241228
Austin, Texas, 78759
Bellaire Dermatology Associates /ID# 232243
Bellaire, Texas, 77401
Skin Wellness Dermatology - Homewood /ID# 241233
Birmingham, Alabama, 35209-8314
Susan H. Weinkle MD /ID# 233835
Bradenton, Florida, 34209-5642
EthiQ2 Research, LLC /ID# 241256
Brookfield, Wisconsin, 53005
DeNova Research /ID# 232231
Chicago, Illinois, 60611
Michigan Center for Research Company /ID# 241255
Clarkston, Michigan, 48346
J&S Studies, Inc. /ID# 241236
College Station, Texas, 77845-3898
Skin Research Institute LLC /ID# 232240
Coral Gables, Florida, 33146-1837
Dallas Center for Dermatology and Aesthetics /ID# 241245
Dallas, Texas, 75225-6203
Advanced Research Associates - Glendale /ID# 232245
Glendale, Arizona, 85308
AboutSkin Research, LLC /ID# 241702
Greenwood Village, Colorado, 80111
Laser and Skin Surgery Center of Indiana /ID# 233834
Indianapolis, Indiana, 46260-2386
Visage Dermatology and Aesthetic Center /ID# 241248
Largo, Maryland, 20774-5341
The Rejuva Center /ID# 244285
Latham, New York, 12110
Advanced Dermatology /ID# 241252
Lincolnshire, Illinois, 60069
Skin Care and Laser Physicians of Beverly Hills /ID# 241237
Los Angeles, California, 90069
The Education & Research Foundation, Inc. /ID# 241225
Lynchburg, Virginia, 24501-1403
Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230
Metairie, Louisiana, 70006
Skin and Cancer Associates, LLP /ID# 232228
Miami, Florida, 33137-3254
image Dermatology, P.C. /ID# 241227
Montclair, New Jersey, 07042
Sherman Aesthetic Center /ID# 241247
Nashville, Tennessee, 37205-2205
Tennessee Clinical Research Center /ID# 241254
Nashville, Tennessee, 37215-2885
Etre Cosmetic Dermatology and Laser Center /ID# 232235
New Orleans, Louisiana, 70130-4353
The Eye Research Foundation /ID# 232229
Newport Beach, California, 92663-3637
Rkmd, Llc /Id# 241239
North Bethesda, Maryland, 20852-3093
Perelman Center for Advanced Medicine - /ID# 243966
Philadelphia, Pennsylvania, 19104-5127
Northwest Dermatology Institute /ID# 233498
Portland, Oregon, 97210-2859
Swinyer-Woseth Dermatology /ID# 241250
Salt Lake City, Utah, 84117-4209
Cosmetic Laser Dermatology /ID# 243513
San Diego, California, 92121-2119
UC San Diego Health - University Center Lane - La Jolla /ID# 241243
San Diego, California, 92122-1013
Ava T. Shamban MD - Santa Monica. /ID# 241246
Santa Monica, California, 90404-2208
Meridian Clinical Research Dermatology /ID# 241234
Savannah, Georgia, 31406-2632
Art of Skin MD /ID# 241244
Solana Beach, California, 92075-2228
Premier Clinical Research /ID# 233836
Spokane, Washington, 99202
ForCare Clinical Research /ID# 241229
Tampa, Florida, 33613-1244
Moradi MD /ID# 241242
Vista, California, 92083-6030
Mariwalla Dermatology /ID# 241240
West Islip, New York, 11795-4916
Puerto Rico2 sites
Santa Cruz Behavioral (SCB) Research Center /ID# 241226
Bayamón, 00961-6910
Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241
San Juan, 00917
About this study
Official title: A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines
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.
Read more
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.
- Conditions
- Glabellar Lines
- Being tested
- AGN-151586
- Keywords
- Glabellar Lines, AGN-151586
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-151586Drug
Powder for Solution for Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| AGN-151586 | Experimental | Participants will receive 5 intramuscular injections in the glabellar complex on Day 1 (Dose 1). Based on meeting the retreatment criteria, the participant may receive up to 2 additional doses of open-label treatments. Receives: Drug: AGN-151586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (Baseline) to Day 126
Participants With Post-Baseline Potentially Clinically Important (PCI) Values for Systolic Blood Pressure
The number of subjects with at least 1 PCI post-baseline value during the study are reported. A post-baseline value was considered PCI if it met both the observed-value and the change-from-baseline criteria.
Measured: Day 1 (Baseline) to Day 126
Participants With Post-Baseline PCI Values for Diastolic Blood Pressure
The number of subjects with at least 1 PCI post-baseline value during the study are reported. A post-baseline value was considered PCI if it met both the observed-value and the change-from-baseline criteria.
Measured: Day 1 (Baseline) to Day 126
Participants With Post-Baseline PCI Values for Heart Rate
The number of subjects with at least 1 PCI post-baseline value during the study are reported. A post-baseline value was considered PCI if it met both the observed-value and the change-from-baseline criteria.
Measured: Day 1 (Baseline) to Day 126
Participants With Post-baseline PCI Values in Temperature
Only the observed-value criterion (>= 38.3 C) was needed for temperature to be potentially clinically important (but must be more extreme than baseline, if baseline was present).
Measured: Day 1 (Baseline) to Day 126
Participants With Post-baseline PCI Values in Electrocardiogram Parameters
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). A post-baseline value is considered potentially clinically important if it meets either the observed-value or the change-from-baseline criteria (but must be more extreme than baseline if baseline is present).
Measured: Day 1 (Baseline) to Day 126
Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586
Blood samples for immunogenicity testing were collected from participants treated with AGN-151586 at predetermined timepoints. Collected samples were processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.
Measured: Day 1 (Baseline) to Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start25 Feb 2022
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248893
- Sponsor's protocol ID
- M21-509
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2022
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.