A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
Study Details
Study Description
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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in toxin-naïve participants with moderate to severe GL.
This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites.
Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AGN-151586 Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586. |
Drug: AGN-151586
Intramuscular Injection
|
| Experimental: Placebo Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586. |
Drug: AGN-151586
Intramuscular Injection
Drug: Placebo
Intramuscular Injection
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments (composite) of Glabellar Lines (GL) severity at maximum frown [Day 7]
The investigator and participant assessments of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
- Number of Participants with Adverse Events [Up to 12 Weeks]
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 from baseline in Vital Sign Measurements [Up to 12 Weeks]
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
- Change from baseline in ECG parameters [Up to 12 Weeks]
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).
- Change from baseline in laboratory evaluations [Up to 12 Weeks]
Percentage of participants with abnormal clinical laboratory values like hematology and chemistry will be assessed.
- Presence of binding and neutralizing antidrug antibodies [Up to 12 Weeks]
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.
Secondary Outcome Measures
- Percentage of participants with ≥ 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown over the double-blind period [Up to 6 Weeks]
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
- Percentage of participants with ≥ 2-grade improvement from baseline on the FWS according to participant assessment of GL severity at maximum frown over the double-blind period [Up to 6 Weeks]
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
- Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Item 5 (overall satisfaction) for GL [Hour 24]
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
- Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 4 (natural look) for GL [Day 7]
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Uncontrolled systemic disease.
-
Participants must not have a history of any use of botulinum neurotoxin of any serotype for any indication (including any investigational botulinum neurotoxin product).
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Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including:
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Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
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History of facial nerve palsy
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Infection or dermatological condition at the treatment injection sites
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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
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History of known immunization to any botulinum neurotoxin serotype.
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Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
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Anticipated need for surgery or overnight hospitalization during the study.
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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).
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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.
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Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or subjects with a positive polymerase chain reaction (PCR) test in the past 14 days prior to Baseline Day 1 who are asymptomatic.
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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.
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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.
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Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clear Dermatology & Aesthetics Center /ID# 238990 | Scottsdale | Arizona | United States | 85255-4134 |
| 2 | Steve Yoelin MD Medical Assoc. Inc /ID# 243197 | Newport Beach | California | United States | 92663-3311 |
| 3 | Marcus Facial Plastic Surgery /ID# 241703 | Redondo Beach | California | United States | 90277 |
| 4 | DMR Research PLLC /ID# 239061 | Westport | Connecticut | United States | 06880-5369 |
| 5 | Kavali Plastic Surgery /ID# 244808 | Atlanta | Georgia | United States | 30328-4402 |
| 6 | Delricht Research - 10154 Jefferson /ID# 244890 | Baton Rouge | Louisiana | United States | 70809-2725 |
| 7 | Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067 | Hunt Valley | Maryland | United States | 21030-3216 |
| 8 | Wilmington Dermatology Center /ID# 233935 | Wilmington | North Carolina | United States | 28403 |
| 9 | Clinical Research Center of the Carolinas /ID# 239064 | Charleston | South Carolina | United States | 29407 |
| 10 | Austin Institute for Clinical Research /ID# 238989 | Pflugerville | Texas | United States | 78660 |
| 11 | Kalo Clinical Research /ID# 247279 | Salt Lake City | Utah | United States | 84102-1686 |
| 12 | SkinDC /ID# 238988 | Arlington | Virginia | United States | 22209 |
| 13 | YVR Aesthetics Training & Study Centre /ID# 241858 | Vancouver | British Columbia | Canada | V5Z 1H2 |
| 14 | Pacific Derm /ID# 239654 | Vancouver | British Columbia | Canada | V6H 4E1 |
| 15 | Dr Melinda Gooderham Medicine Profession /ID# 239657 | Cobourg | Ontario | Canada | K9A 0Z4 |
| 16 | The Centre for Clinical Trials /ID# 245873 | Oakville | Ontario | Canada | L6J 7W5 |
| 17 | Clinique D /ID# 239653 | Laval | Quebec | Canada | H7N 6L2 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: ALLERGAN INC., Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M21-508