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

NCT ID: NCT06308198

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-29

Study Completion Date

2025-02-26

Brief Summary

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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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Detailed Description

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Double-Blind Period: AGN-151586

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

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

Intramuscular Injections

Double-Blind Period: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intramuscular Injections

Open-Label: AGN-151586

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

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

Intramuscular Injections

Interventions

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AGN-151586

Intramuscular Injections

Intervention Type DRUG

Placebo

Intramuscular Injections

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Beijing Hospital /ID# 256084

Beijing, Beijing Municipality, China

Site Status

Dermatology Hospital of Southern Medical University /ID# 256172

Guangzhou, Guangdong, China

Site Status

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

Wuhan, Hubei, China

Site Status

Nanjing Drum Tower Hospital /ID# 255936

Nanjing, Jiangsu, China

Site Status

Zhongda Hospital Southeast University /ID# 255937

Nanjing, Jiangsu, China

Site Status

Wuxi People's Hospital /ID# 256029

Wuxi, Jiangsu, China

Site Status

Xianyang Hospital of Yan'an University /ID# 256774

Xianyang, Shaanxi, China

Site Status

Huashan Hospital, Fudan University /ID# 255870

Shanghai, Shanghai Municipality, China

Site Status

Zhejiang Provincial People's Hospital /ID# 256028

Hangzhou, Zhejiang, China

Site Status

Tokyo Center Clinic /ID# 267380

Chuo-ku, Tokyo, Japan

Site Status

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

Kaohsiung City, , Taiwan

Site Status

Tri-Service General Hospital /ID# 260673

Taipei, , Taiwan

Site Status

Countries

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China Japan Taiwan

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M24-008

Related Info

Other Identifiers

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M24-008

Identifier Type: -

Identifier Source: org_study_id

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