A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines

Study Identifier
M24-008
CT.gov Identifier
NCT06308198
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • AGN-151586
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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 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.

    Study Locations

    Location
    Status
    Location
    Beijing Hospital /ID# 256084
    Beijing, Beijing Municipality, China, 100730
    Status
    Not applicable
    Location
    Dermatology Hospital of Southern Medical University /ID# 256172
    Guangzhou, Guangdong, China, 510091
    Status
    Not applicable
    Location
    Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871
    Wuhan, Hubei, China, 430022
    Status
    Not applicable
    Location
    Nanjing Drum Tower Hospital /ID# 255936
    Nanjing, Jiangsu, China, 210008
    Status
    Not applicable
    Location
    Zhongda Hospital Southeast University /ID# 255937
    Nanjing, Jiangsu, China, 210009
    Status
    Not applicable
    Location
    Wuxi People's Hospital /ID# 256029
    Wuxi, Jiangsu, China, 214023
    Status
    Not applicable
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