Glabellar LinesPhase 3NCT05248880
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
A Phase 3 study testing AGN-151586 in people with Glabellar Lines, run by AbbVie at 17 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 small quantities of botulinum toxin. AGN-151586 is an investigational product being developed for the treatment of GL. 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?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 8 Mar 2022to 1 Feb 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.
- 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
Show all 17Show fewer
- 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).
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States12 sites
SkinDC /ID# 238988
Arlington, Virginia, 22209
Duplicate_Kavali Plastic Surgery and Skin Renewal Center /ID# 244808
Atlanta, Georgia, 30328
DelRicht Research /ID# 244890
Baton Rouge, Louisiana, 70809
Clinical Research Center of the Carolinas /ID# 239064
Charleston, South Carolina, 29407
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067
Hunt Valley, Maryland, 21030-3216
Steve Yoelin MD Medical Associate Inc /ID# 243197
Newport Beach, California, 92663
Duplicate_Austin Institute for Clinical Research /ID# 238989
Pflugerville, Texas, 78660
Marcus Medical Spa /ID# 241703
Redondo Beach, California, 90277
Clear Dermatology & Aesthetics Center /ID# 238990
Scottsdale, Arizona, 85255-4134
Kalo Clinical Research /ID# 247279
West Valley City, Utah, 84120-2058
DMR Research PLLC /ID# 239061
Westport, Connecticut, 06880
WDC Cosmetic and Research, PLLC /ID# 233935
Wilmington, North Carolina, 28405
Canada5 sites
Dr Melinda Gooderham Medicine Profession /ID# 239657
Cobourg, Ontario, K9A 0Z4
Clinique D /ID# 239653
Laval, Quebec, H7N 6L2
The Centre for Clinical Trials /ID# 245873
Oakville, Ontario, L6J 7W5
YVR Aesthetics Training & Study Centre /ID# 241858
Vancouver, British Columbia, V5Z 1H2
Pacific Derm /ID# 239654
Vancouver, British Columbia, V6H 4E1
About this study
Official title: A Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines in Toxin-Naïve Subjects
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.
Read more
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
- Being tested
- AGN-151586, Placebo
- 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
Intramuscular Injection
PlaceboDrug
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: AGN-151586; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]
[Secondary 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 over time 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.
Measured: 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]
[Secondary endpoint for the United States FDA] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time 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.
Measured: 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]
Secondary endpoint for the United States FDA] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time 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.
Measured: 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]
[Secondary endpoint for the United States FDA] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Measured: 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]
[Secondary endpoint for the United States FDA] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Measured: Hour 24 (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 4 (Natural Look) for GL at Day 7 [US FDA]
[Secondary endpoint for the United States FDA] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Measured: Day 7 (Double-blind Period)
Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Percentages are rounded off to nearest single decimal.
Measured: Baseline, Day 7 (Double-blind Period)
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
[Secondary 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 Hour 24 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.
Measured: Baseline, Hour 24 (Double-blind Period)
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
[Secondary 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 Hour 24 during the Double-Blind Period 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.
Measured: Baseline, Hour 24 (Double-blind Period)
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 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.
Measured: Baseline, Hour 24 (Double-blind Period)
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 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.
Measured: Baseline, Hour 24 (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 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective.
Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS):
very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Measured: Hour 24 (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 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective.
Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Measured: Day 7 (Double-blind Period)
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 10 (Look Angry). Percentages are rounded off to nearest single decimal.
Measured: Day 7 (Double-blind Period)
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies]
[Secondary endpoint for European Union regulatory agencies] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 5 (Look Less Attractive). Percentages are rounded off to nearest single decimal.
Measured: Baseline, Day 7 (Double-blind Period)
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 start8 Mar 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248880
- Sponsor's protocol ID
- M21-508
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2022
- Last updated
- 18 Feb 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.