A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Glabellar Lines Clinical Trial

Official title:

A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248893
• Other study ID #: M21-509
• Status: Completed
• Phase: Phase 3
• Start date: February 25, 2022
• Est. completion date: June 26, 2023

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 of AGN-151586 over multiple repeat 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, 126 day 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 cycles 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 986
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• 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).

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• AGN-151586
Intramuscular Injection

Locations

Country	Name	City	State
Puerto Rico	Santa Cruz Behavioral (SCB) Research Center /ID# 241226	Bayamon
Puerto Rico	Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241	San Juan
United States	Hamilton Research, LLC /ID# 241232	Alpharetta	Georgia
United States	Atlanta Biomedical Clinical Research /ID# 241258	Atlanta	Georgia
United States	Rao Dermatology /ID# 243515	Atlantic Highlands	New Jersey
United States	DermResearch, Inc. Austin, TX /ID# 241228	Austin	Texas
United States	Bellaire Dermatology Associates /ID# 232243	Bellaire	Texas
United States	Skin Wellness Dermatology - Homewood /ID# 241233	Birmingham	Alabama
United States	Susan H. Weinkle MD /ID# 233835	Bradenton	Florida
United States	EthiQ2 Research, LLC /ID# 241256	Brookfield	Wisconsin
United States	DeNova Research /ID# 232231	Chicago	Illinois
United States	Michigan Center for Research Company /ID# 241255	Clarkston	Michigan
United States	J&S Studies, Inc. /ID# 241236	College Station	Texas
United States	Skin Research Institute LLC /ID# 232240	Coral Gables	Florida
United States	Dallas Center for Dermatology and Aesthetics /ID# 241245	Dallas	Texas
United States	Advanced Research Associates - Glendale /ID# 232245	Glendale	Arizona
United States	AboutSkin Research, LLC /ID# 241702	Greenwood Village	Colorado
United States	Laser and Skin Surgery Center of Indiana /ID# 233834	Indianapolis	Indiana
United States	Visage Dermatology and Aesthetic Center /ID# 241248	Largo	Maryland
United States	The Rejuva Center /ID# 244285	Latham	New York
United States	Advanced Dermatology /ID# 241252	Lincolnshire	Illinois
United States	Skin Care and Laser Physicians of Beverly Hills /ID# 241237	Los Angeles	California
United States	The Education & Research Foundation, Inc. /ID# 241225	Lynchburg	Virginia
United States	Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230	Metairie	Louisiana
United States	Skin and Cancer Associates, LLP /ID# 232228	Miami	Florida
United States	image Dermatology, P.C. /ID# 241227	Montclair	New Jersey
United States	Sherman Aesthetic Center /ID# 241247	Nashville	Tennessee
United States	Tennessee Clinical Research Center /ID# 241254	Nashville	Tennessee
United States	Etre Cosmetic Dermatology and Laser Center /ID# 232235	New Orleans	Louisiana
United States	The Eye Research Foundation /ID# 232229	Newport Beach	California
United States	Rkmd, Llc /Id# 241239	North Bethesda	Maryland
United States	Perelman Center for Advanced Medicine - /ID# 243966	Philadelphia	Pennsylvania
United States	Northwest Dermatology Institute /ID# 233498	Portland	Oregon
United States	Swinyer-Woseth Dermatology /ID# 241250	Salt Lake City	Utah
United States	Cosmetic Laser Dermatology /ID# 243513	San Diego	California
United States	UC San Diego Health - University Center Lane - La Jolla /ID# 241243	San Diego	California
United States	Ava T. Shamban MD - Santa Monica. /ID# 241246	Santa Monica	California
United States	Meridian Clinical Research Dermatology /ID# 241234	Savannah	Georgia
United States	Art of Skin MD /ID# 241244	Solana Beach	California
United States	Premier Clinical Research /ID# 233836	Spokane	Washington
United States	ForCare Clinical Research /ID# 241229	Tampa	Florida
United States	Moradi MD /ID# 241242	Vista	California
United States	Mariwalla Dermatology /ID# 241240	West Islip	New York

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	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.	Day 1 to Day 126
Primary	Change in Vital Sign Measurements	Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Day 1 to Day 126
Primary	Change in Electrocardiogram (ECG) Measurements	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).	Day 1 to Day 126
Primary	Presence of binding and neutralizing antidrug antibodies	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.	Day 1 to Day 126