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

NCT05248880 | Completed Phase 3 Results FDA Drug

• 1 other identifier: M21-508
• Study Type: interventional
• Target: 309
• Locations: 2 countries
• Sites: 17

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. 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.

Conditions

Glabellar Lines

Keywords

Glabellar Lines; AGN-151586

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]

  \[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

  Baseline, Day 7 (Double-blind period)

• Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]

  \[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

  Baseline, Day 7 (Double-blind period)

• Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]

  \[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

  Baseline, Day 7 (Double-blind Period)

• 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.

  From time of informed consent to end of study; median time on follow-up was 85 days for all groups.

Secondary Outcomes (15)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]

  Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]

  Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]

  Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

• Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA]

  Day 7 (Double-blind Period)

• Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA]

  Hour 24 (Double-blind Period)

Study Arms (2)

AGN-151586

EXPERIMENTAL

Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.

Drug: AGN-151586

Placebo

EXPERIMENTAL

Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.

Drug: AGN-151586; Drug: Placebo

Interventions

AGN-151586 DRUG

Intramuscular Injection

AGN-151586; Placebo

Placebo DRUG

Intramuscular Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (17)

Clear Dermatology & Aesthetics Center /ID# 238990

Scottsdale, Arizona, 85255-4134, United States

Location

Steve Yoelin MD Medical Associate Inc /ID# 243197

Newport Beach, California, 92663, United States

Location

Marcus Medical Spa /ID# 241703

Redondo Beach, California, 90277, United States

Location

DMR Research PLLC /ID# 239061

Westport, Connecticut, 06880, United States

Location

Duplicate_Kavali Plastic Surgery and Skin Renewal Center /ID# 244808

Atlanta, Georgia, 30328, United States

Location

DelRicht Research /ID# 244890

Baton Rouge, Louisiana, 70809, United States

Location

Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067

Hunt Valley, Maryland, 21030-3216, United States

Location

WDC Cosmetic and Research, PLLC /ID# 233935

Wilmington, North Carolina, 28405, United States

Location

Clinical Research Center of the Carolinas /ID# 239064

Charleston, South Carolina, 29407, United States

Location

Duplicate_Austin Institute for Clinical Research /ID# 238989

Pflugerville, Texas, 78660, United States

Location

Kalo Clinical Research /ID# 247279

West Valley City, Utah, 84120-2058, United States

Location

SkinDC /ID# 238988

Arlington, Virginia, 22209, United States

Location

YVR Aesthetics Training & Study Centre /ID# 241858

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Pacific Derm /ID# 239654

Vancouver, British Columbia, V6H 4E1, Canada

Location

Dr Melinda Gooderham Medicine Profession /ID# 239657

Cobourg, Ontario, K9A 0Z4, Canada

Location

The Centre for Clinical Trials /ID# 245873

Oakville, Ontario, L6J 7W5, Canada

Location

Clinique D /ID# 239653

Laval, Quebec, H7N 6L2, Canada

Location

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 21, 2022
• Study Start: March 8, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 18, 2026
• Results First Posted: February 18, 2026

Record last verified: 2026-01

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/

Locations

CA (5); US (12)