A Phase 3 multi-center research study to evaluate the safety and how well the study drug, AGN-151586, works for the treatment of glabellar lines (frown lines between the eyebrows)
- Conditions
- Moderate to Severe Glabellar Lines (GL)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2021-003667-10-HU
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
- Adult male or female, at least 18 years old
- Subjects must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable)
- Subjects 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.
- Subjects must have moderate or severe GL at maximum frown as assessed by both the investigator and subject using the FWS at Screening and Baseline Day 1 Visit. The investigator and subject ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Subjects who have an uncontrolled systemic disease
- Subjects who have previously received treatment with any botulinum neurotoxin of any serotype for aesthetic treatment within the last 6 months prior to Baseline Day 1 and for therapeutic treatment within the last 12 months prior to Baseline Day 1
- Subjects who presents with or have a 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 Visits as determined by the investigator
- Subjects who have a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- Subjects who have a history of an allergic reaction or significant sensitivity to constituents of the study drug (or its excipients).
- Subjects who have tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
- Subjects who have a known immunization to any botulinum neurotoxin serotype.
- Subjects who have an anticipated need for surgery or overnight hospitalization during the study.
- Subjects who have a 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).
- Subjects who have a 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.
- Female subjects who are pregnant or breastfeeding, or are considering becoming pregnant or donating eggs during the study or within approximately 30 days after the last dose of study drug or before the end of study, whichever is longer.
- Subjects who have been treated with any investigational drug within 30 days prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- Subjects who have an anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).
- Subjects who have a clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula > 450 msec (males) or > 470 msec (females).
- Subjects with known active COVID infection or subjects with a positive polymerase chain reaction (PCR) test in the past 14 days prior to Baseline Day 1
- Female subjects of child-bearing potential who have a positive serum pregnancy test at screening and a positive urine pregnancy test at the Baseline Day 1 Visit (prior to the dose of study drug).
- Female subjects who are pregnant or breastfeeding, and are considering becoming pregnant or donating eggs during the study or f
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this pivotal study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in subjects with moderate to severe GL;Secondary Objective: Not applicable;Primary end point(s): The co-primary endpoints are:<br>- = 2-grade improvement from baseline on the Facial Wrinkle Scale (FWS) according to subject assessment of GL severity at maximum frown at Day 7<br>- = 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown at Day 7;Timepoint(s) of evaluation of this end point: Day 7 (6 days after the baseline Day 1 visit)
- Secondary Outcome Measures
Name Time Method