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Completed

NCT Number: NCT06308198

A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for 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 small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.

AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.

Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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Key information

Conditions

Glabellar Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital /ID# 256084, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the FWS-A at Screening and Baseline Day 1 visit. The investigator and participant ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
  • Must be in good health as per investigator's judgment based on medical history, physical examination, and vital sign measurements.

Exclusion criteria

  • Uncontrolled systemic disease.
  • Infection or dermatological condition at the treatment injection sites.

Treatment and study plan

AGN-151586

Drug

Intramuscular Injections

Placebo

Drug

Intramuscular Injections

Primary outcomes

  1. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown

    Time frame: Day 7

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  2. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown

    Time frame: Day 7

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  3. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately Day 84

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown

    Time frame: Hour 24

    Participant's assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  2. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown

    Time frame: Hour 24

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  3. Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL

    Time frame: Hour 24

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 5 (satisfaction with the effect of treatment) can also be used as a stand-alone item.

  4. Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 4 (natural look) for GL

    Time frame: Day 7

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 4 (satisfaction with the natural look) can also be used as a stand-alone item.

  5. Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL Over Time

    Time frame: Baseline up to approximately Day 84

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 5 (satisfaction with the effect of treatment) can also be used as a stand-alone item.

  6. Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Participant Assessment of GL Severity at Maximum Frown

    Time frame: Baseline to Day 42

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  7. Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Investigator Assessment of GL Severity at Maximum Frown

    Time frame: Baseline to Day 42

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  8. Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown Over Time

    Time frame: Baseline to Day 42

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  9. Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown Over Time

    Time frame: Baseline to Day 42

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  10. Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown

    Time frame: Baseline to Day 42

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  11. Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown

    Time frame: Baseline to Day 42

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  12. Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time

    Time frame: Baseline to Day 84

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  13. Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time

    Time frame: Baseline to Day 84

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  14. Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown

    Time frame: Hour 24

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  15. Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown

    Time frame: Hour 24

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

  16. Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL

    Time frame: Day 7

    The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact. Total scores are transformed to a 0 to 100 scale, with higher scores indicating better psychosocial outcomes.

  17. Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL

    Time frame: Day 7

    The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact.

  18. Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL

    Time frame: Day 7

    The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact.

  19. Percentage of Partcipatns who Achieve Patient-Reported Global Assessment of Change in GL Based on the Global Assessment of Change in Glabellar Lines (GAC-GL) Over Time

    Time frame: Baseline up to approximately Day 84

    The GAC-GL Questionnaire is a 2-item measure that assesses the appearance of the participant's GL "now" in comparison with their perspective before treatment at rest and at maximum furrow. The response options are scored on a 7-point VDS ranging from Very much improved to Very much worse. Scores are unique for at rest and maximum contraction, and they are simply the responses to the items.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of AGN-151586 for the Treatment of Moderate to Severe Glabellar Lines

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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