Clinical trial NCT06308198: A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of AGN-151586 for the Treatment of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Keywords: Glabellar Lines
AGN-151586
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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
timeFrame: Day 7
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
timeFrame: Day 7
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately Day 84
Secondary outcomes:
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
timeFrame: Hour 24
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
timeFrame: Hour 24
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
timeFrame: Hour 24
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
timeFrame: Day 7
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
timeFrame: Baseline up to approximately Day 84
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
timeFrame: Baseline to Day 42
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
timeFrame: Baseline to Day 42
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
timeFrame: Baseline to Day 42
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
timeFrame: Baseline to Day 42
measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown
timeFrame: Baseline to Day 42
measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown
timeFrame: Baseline to Day 42
measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time
timeFrame: Baseline to Day 84
measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time
timeFrame: Baseline to Day 84
measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown
timeFrame: Hour 24
measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown
timeFrame: Hour 24
measure: Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL
timeFrame: Day 7
measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL
timeFrame: Day 7
measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL
timeFrame: Day 7
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
timeFrame: Baseline up to approximately Day 84
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital /ID# 256084
state: Beijing
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University /ID# 256172
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 255936
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 255937
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital /ID# 256029
state: Jiangsu
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University /ID# 256774
state: Shaanxi
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 255870
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital /ID# 256028
state: Zhejiang
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic /ID# 267380
state: Tokyo
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 260669
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 260673
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: