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

NCT ID: NCT05248867

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 638 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2023-03-17

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 was to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL.

This was a 12-week study in which eligible subjects were enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants were randomly assigned to receive AGN-151586 or placebo. There was 1 in a 4 chance that participants would receive placebo. Around 600 adult participants with moderate to severe GL were to be enrolled in the study in approximately 38 sites across the world.

Participants received either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may have received an open-label treatment of AGN-151586 during the study.

Participants attended regular visits during the study at a study site. The effect of the treatment was checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

Conditions

Glabellar Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo solution for injection

AGN-151586

Intervention Type: DRUG

AGN-151586 solution for injection

AGN-151586

Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.

Group Type: EXPERIMENTAL

AGN-151586

Intervention Type: DRUG

AGN-151586 solution for injection

Interventions

Placebo

Placebo solution for injection

Intervention Type: DRUG

AGN-151586

AGN-151586 solution for injection

Intervention Type: DRUG

Eligibility 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.
• 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:

• 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 neurotoxin 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 Baseline (Day 1 of treatment) 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 (SARS-CoV-2) infection.
• Female participant 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Total Skin and Beauty Derm Ctr /ID# 232378

Birmingham, Alabama, United States

Clinical Testing of Beverly Hills /ID# 233195

Encino, California, United States

Westside Aesthetics /ID# 232443

Los Angeles, California, United States

The Research Center at The Maas Clinic /ID# 241262

San Francisco, California, United States

Center for Dermatology and Dermatologic Surgery /ID# 232315

Washington D.C., District of Columbia, United States

Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232439

Boca Raton, Florida, United States

Dermatology Clinic & Cosmetic Center /ID# 244295

Baton Rouge, Louisiana, United States

Delricht Research /ID# 241253

New Orleans, Louisiana, United States

Skincare Physicians /ID# 233938

Chestnut Hill, Massachusetts, United States

BOYD Beauty Birmingham /ID# 232383

Birmingham, Michigan, United States

Skin Search of Rochester Inc. /ID# 232549

Rochester, New York, United States

Aesthetic Solutions /ID# 232389

Chapel Hill, North Carolina, United States

Aventiv Research Dublin /ID# 233936

Dublin, Ohio, United States

KGL Skin Study Center, LLC /ID# 233549

Newtown Square, Pennsylvania, United States

Nashville Center for Laser and Facial Surgery /ID# 242535

Nashville, Tennessee, United States

Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232410

Austin, Texas, United States

Dallas Plastic Surgery Institute /ID# 232328

Dallas, Texas, United States

Austin Institute for Clinical Research at SBA Dermatology /ID# 232316

Houston, Texas, United States

Beacon Dermatology Inc /ID# 233227

Calgary, Alberta, Canada

Alberta DermaSurgery Centre /ID# 241172

Edmonton, Alberta, Canada

Dr. Wei Jing Loo Medicine Prof /ID# 241863

London, Ontario, Canada

Erevna Innovations Inc. /ID# 239592

Westmount, Quebec, Canada

Studienzentrum Theatiner46 /ID# 241185

Munich, Bavaria, Germany

Rosenpark Research /ID# 232391

Darmstadt, Hesse, Germany

Privatpraxis Dr. Hilton & Partner /ID# 232392

Düsseldorf, North Rhine-Westphalia, Germany

Noahklinik GmbH /ID# 241184

Kassel, , Germany

Hautok and Hautok-cosmetics /ID# 232393

München, , Germany

Privatpraxis fuer Dermatologie und Aesthetik /ID# 241544

München, , Germany

MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 241186

Oberursel, , Germany

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 244708

Szeged, Csongrád megye, Hungary

Derm-Surg Kft. /ID# 244709

Kaposvár, Somogy County, Hungary

Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 244706

Debrecen, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 244707

Pécs, , Hungary

Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 242990

Oświęcim, Lesser Poland Voivodeship, Poland

Clinical Research Group Sp. z o.o. /ID# 242988

Warsaw, Masovian Voivodeship, Poland

High-Med Przychodnia Specjalistyczna /ID# 242973

Warsaw, Masovian Voivodeship, Poland

Novo-Med Zielinski i Wspolnicy Spolka Jawna /ID# 242986

Katowice, Silesian Voivodeship, Poland

Dermed Centrum Medyczne Sp. z o.o /ID# 242972

Lodz, Łódź Voivodeship, Poland

Countries

United States; Canada; Germany; Hungary; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-003667-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M21-500

Identifier Type: -

Identifier Source: org_study_id