Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines

NCT06151561 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-040
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 over a range of doses for the treatment of moderate to severe GL in Japanese participants. AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. 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

Moderate to Severe Glabellar Lines

Keywords

Glabellar Lines, AGN-151586

Outcome Measures

Primary Outcomes (1)

• 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, at any timepoint through Day 7

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

  Baseline (Day 1) through Day 7

Secondary Outcomes (3)

• Percentage of participants with a >= 2-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time

  Baseline (Day 1) through End of Study (Up to Day 42)

• Percentage of participants with a >= 1-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time

  Baseline (Day 1) through End of Study (Up to Day 42)

• Percentage of participants with a None or Mild on the FWS-A according to investigator assessment of GL severity at maximum frown over time

  Baseline (Day 1) through End of Study (Up to Day 42)

Study Arms (4)

Dose 1

EXPERIMENTAL

Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1.

Drug: AGN-151586

Dose 2

EXPERIMENTAL

Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1.

Drug: AGN-151586

Dose 3

EXPERIMENTAL

Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1.

Drug: AGN-151586

Placebo

PLACEBO COMPARATOR

Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1.

Drug: Placebo

Interventions

AGN-151586 DRUG

Intramuscular Injection

Dose 1; Dose 2; Dose 3

Placebo DRUG

Intramuscular Injection

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
• Participants must have moderate or severe GL at maximum frown as assessed by the investigator using the FWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.

You may not qualify if:

• Participants must not have uncontrolled systemic disease.
• History of known immunization to any botulinum neurotoxin serotype
• Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
• Anticipated need for surgery or overnight hospitalization during the study.
• History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
• History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
• Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
• Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
• Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
• Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Tokyo Center Clinic /ID# 257898

Central District, Tokyo, 103-0028, Japan

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: November 30, 2023
• Study Start: January 5, 2024
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

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: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (1)