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

Study Overview
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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 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.

Official Title
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A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatment of Japanese Subjects With Moderate to Severe Glabellar Lines

Conditions
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Moderate to Severe Glabellar Lines

Intervention / Treatment
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* Drug: AGN-151586
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. | Drug: AGN-151586<br>* Intramuscular Injection<br>|
| Experimental: Dose 2<br>Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. | Drug: AGN-151586<br>* Intramuscular Injection<br>|
| Experimental: Dose 3<br>Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. | Drug: AGN-151586<br>* Intramuscular Injection<br>|
| Placebo Comparator: Placebo<br>Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. | Drug: Placebo<br>* Intramuscular Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with a >=2-grade improvement from baseline on the Facial Wrinkle Scale with Asian (FWS-A) Photonumeric 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 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 | 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 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 | 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 End of Study (Up to Day 42) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glabellar Lines, AGN-151586