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

NCT06308198 | Completed Phase 3

• 1 other identifier: M24-008
• Study Type: interventional
• Target: 161
• Locations: 3 countries
• Sites: 12

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. 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.

Conditions

Glabellar Lines

Keywords

Glabellar Lines; AGN-151586

Outcome Measures

Primary Outcomes (3)

• 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

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

  Day 7

• 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

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

  Day 7

• Number of Participants with Adverse Events (AEs)

  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.

  Up to approximately Day 84

Secondary Outcomes (19)

• 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

  Hour 24

• 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

  Hour 24

• 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

  Hour 24

• 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

  Day 7

• 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

  Baseline up to approximately Day 84

Study Arms (3)

Double-Blind Period: AGN-151586

EXPERIMENTAL

Participants will receive AGN-151586 in the glabellar complex on Day 1.

Drug: AGN-151586

Double-Blind Period: Placebo

PLACEBO COMPARATOR

Participants will receive Placebo in the glabellar complex on Day 1.

Drug: Placebo

Open-Label: AGN-151586

EXPERIMENTAL

Participants who meet all retreatment criteria will receive AGN-151586 in the glabellar complex on Day 43.

Drug: AGN-151586

Interventions

AGN-151586 DRUG

Intramuscular Injections

Double-Blind Period: AGN-151586; Open-Label: AGN-151586

Placebo DRUG

Intramuscular Injections

Double-Blind Period: Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (12)

Beijing Hospital /ID# 256084

Beijing, Beijing Municipality, 100730, China

Location

Dermatology Hospital of Southern Medical University /ID# 256172

Guangzhou, Guangdong, 510091, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 255936

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 255937

Nanjing, Jiangsu, 210009, China

Location

Wuxi People's Hospital /ID# 256029

Wuxi, Jiangsu, 214023, China

Location

Xianyang Hospital of Yan'an University /ID# 256774

Xianyang, Shaanxi, 712000, China

Location

Huashan Hospital, Fudan University /ID# 255870

Shanghai, Shanghai Municipality, 200040, China

Location

Zhejiang Provincial People's Hospital /ID# 256028

Hangzhou, Zhejiang, 310014, China

Location

Tokyo Center Clinic /ID# 267380

Chuo-ku, Tokyo, 103-0027, Japan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 260669

Kaohsiung City, 807, Taiwan

Location

Tri-Service General Hospital /ID# 260673

Taipei, 11490, Taiwan

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: March 29, 2024
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

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: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (9); JP (1); TW (2)