A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 992
- 试验地点
- 86
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with botulinum toxin. The primary purpose of this study is to evaluate the safety of AGN-151586 over up to three treatments of the study drug to improve the appearance of glabellar lines.
AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States.
This is an open-label study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional doses of treatment during the study.
Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable).
- •Participant must have moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline Day 1 visit.
排除标准
- •Uncontrolled systemic disease.
- •Presence or history of any medical condition that may place the subject at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including:
- •Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- •History of facial nerve palsy
- •Infection or dermatological condition at the treatment injection sites
- •Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
- •Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator
- •History of known immunization to any botulinum toxin serotype.
- •Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to screening and for therapeutic treatment within the last 12 months prior to study drug administration.
- •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 (SARSCoV-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 or 5 half-lives of the drug (whichever is longer) 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).
研究组 & 干预措施
AGN-151586
Participants will receive 5 intramuscular injections in the glabellar complex on Day 1 (Dose 1). Based on meeting the retreatment criteria, the participant may receive up to 2 additional doses of open-label treatments.
干预措施: AGN-151586 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Day 1 (Baseline) to Day 126
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Participants With Post-Baseline Potentially Clinically Important (PCI) Values for Systolic Blood Pressure
时间窗: Day 1 (Baseline) to Day 126
The number of subjects with at least 1 PCI post-baseline value during the study are reported. A post-baseline value was considered PCI if it met both the observed-value and the change-from-baseline criteria.
Participants With Post-Baseline PCI Values for Diastolic Blood Pressure
时间窗: Day 1 (Baseline) to Day 126
The number of subjects with at least 1 PCI post-baseline value during the study are reported. A post-baseline value was considered PCI if it met both the observed-value and the change-from-baseline criteria.
Participants With Post-Baseline PCI Values for Heart Rate
时间窗: Day 1 (Baseline) to Day 126
The number of subjects with at least 1 PCI post-baseline value during the study are reported. A post-baseline value was considered PCI if it met both the observed-value and the change-from-baseline criteria.
Participants With Post-baseline PCI Values in Temperature
时间窗: Day 1 (Baseline) to Day 126
Only the observed-value criterion (\>= 38.3 C) was needed for temperature to be potentially clinically important (but must be more extreme than baseline, if baseline was present).
Participants With Post-baseline PCI Values in Electrocardiogram Parameters
时间窗: Day 1 (Baseline) to Day 126
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF). A post-baseline value is considered potentially clinically important if it meets either the observed-value or the change-from-baseline criteria (but must be more extreme than baseline if baseline is present).
Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586
时间窗: Day 1 (Baseline) to Day 126
Blood samples for immunogenicity testing were collected from participants treated with AGN-151586 at predetermined timepoints. Collected samples were processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.
Change in Vital Sign Measurements
时间窗: Day 1 to Day 126
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Adverse Events
时间窗: Day 1 to Day 126
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Change in Electrocardiogram (ECG) Measurements
时间窗: Day 1 to Day 126
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Presence of binding and neutralizing antidrug antibodies
时间窗: Day 1 to Day 126
Blood samples for immunogenicity testing will be collected from all participants treated with AGN-151586 at predetermined timepoints. Collected samples will be processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.
次要结局
未报告次要终点