protocolSection identificationModule nctId: NCT06308198, orgStudyIdInfo id: M24-008, briefTitle: A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-22, completionDateStruct date: 2025-03-22, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Glabellar Lines, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: AGN-151586, interventions name: Placebo, outcomesModule primaryOutcomes measure: 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, primaryOutcomes measure: 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, primaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown, secondaryOutcomes measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown, secondaryOutcomes measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time, secondaryOutcomes measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time, secondaryOutcomes measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL, secondaryOutcomes measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL, secondaryOutcomes measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL, secondaryOutcomes measure: 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, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Hospital /ID# 256084, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Dermatology Hospital of Southern Medical University /ID# 256172, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510091, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Zhongda Hospital Southeast University /ID# 255937, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Xianyang Hospital of Yan'an University /ID# 256774, status: RECRUITING, city: Xianyang, state: Shaanxi, zip: 712000, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 260669, status: RECRUITING, city: Kaohsiung, zip: 807, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False