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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Glabellar Lines

Treatments: Drug: AGN-151586; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06308198

M24-008

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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161 participants in 3 patient groups, including a placebo group

Double-Blind Period: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586

Double-Blind Period: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Open-Label: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586