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

NCT05248867 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M21-5002021-003667-10
• Study Type: interventional
• Target: 638
• Locations: 5 countries
• Sites: 38

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

Keywords

Glabellar Lines; AGN-151586

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]

  \[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

  Baseline, Day 7 (Double-blind period)

• Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]

  \[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

  Baseline, Day 7 (Double-blind period)

• Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]

  \[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

  Baseline, Day 7 (Double-blind Period)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  From time of informed consent to end of study; median time on follow-up was 85 days for Double-blind Placebo, AGN-151586, Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for Placebo/None group, and 53 days for AGN-151586/None group

Secondary Outcomes (23)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]

  Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]

  Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

• Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]

  Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

• Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA]

  Day 7 (Double-blind Period)

• Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA]

  Hour 24 (Double-blind Period)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: AGN-151586

AGN-151586

EXPERIMENTAL

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.

Drug: AGN-151586

Interventions

Placebo DRUG

Placebo solution for injection

Placebo

AGN-151586 DRUG

AGN-151586 solution for injection

AGN-151586; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (38)

Total Skin and Beauty Derm Ctr /ID# 232378

Birmingham, Alabama, 35205, United States

Location

Clinical Testing of Beverly Hills /ID# 233195

Encino, California, 91436-2124, United States

Location

Westside Aesthetics /ID# 232443

Los Angeles, California, 90025-1708, United States

Location

The Research Center at The Maas Clinic /ID# 241262

San Francisco, California, 94115-1809, United States

Location

Center for Dermatology and Dermatologic Surgery /ID# 232315

Washington D.C., District of Columbia, 20037-1445, United States

Location

Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232439

Boca Raton, Florida, 33431-6465, United States

Location

Dermatology Clinic & Cosmetic Center /ID# 244295

Baton Rouge, Louisiana, 70808-4691, United States

Location

Delricht Research /ID# 241253

New Orleans, Louisiana, 70115, United States

Location

Skincare Physicians /ID# 233938

Chestnut Hill, Massachusetts, 02467, United States

Location

BOYD Beauty Birmingham /ID# 232383

Birmingham, Michigan, 48009-6301, United States

Location

Skin Search of Rochester Inc. /ID# 232549

Rochester, New York, 14623, United States

Location

Aesthetic Solutions /ID# 232389

Chapel Hill, North Carolina, 27517-9901, United States

Location

Aventiv Research Dublin /ID# 233936

Dublin, Ohio, 43016, United States

Location

KGL Skin Study Center, LLC /ID# 233549

Newtown Square, Pennsylvania, 19073-2228, United States

Location

Nashville Center for Laser and Facial Surgery /ID# 242535

Nashville, Tennessee, 37203-1513, United States

Location

Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232410

Austin, Texas, 78746-4720, United States

Location

Dallas Plastic Surgery Institute /ID# 232328

Dallas, Texas, 75231, United States

Location

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

Houston, Texas, 77056-4129, United States

Location

Beacon Dermatology Inc /ID# 233227

Calgary, Alberta, T3E 0B2, Canada

Location

Alberta DermaSurgery Centre /ID# 241172

Edmonton, Alberta, T6G 1C3, Canada

Location

Dr. Wei Jing Loo Medicine Prof /ID# 241863

London, Ontario, N6H 5L5, Canada

Location

Erevna Innovations Inc. /ID# 239592

Westmount, Quebec, H3C 1Z3, Canada

Location

Studienzentrum Theatiner46 /ID# 241185

Munich, Bavaria, 80333, Germany

Location

Rosenpark Research /ID# 232391

Darmstadt, Hesse, 64283, Germany

Location

Privatpraxis Dr. Hilton & Partner /ID# 232392

Düsseldorf, North Rhine-Westphalia, 40212, Germany

Location

Noahklinik GmbH /ID# 241184

Kassel, 34117, Germany

Location

Hautok and Hautok-cosmetics /ID# 232393

München, 80333, Germany

Location

Privatpraxis fuer Dermatologie und Aesthetik /ID# 241544

München, 80539, Germany

Location

MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 241186

Oberursel, 61440, Germany

Location

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

Szeged, Csongrád megye, 6725, Hungary

Location

Derm-Surg Kft. /ID# 244709

Kaposvár, Somogy County, 7400, Hungary

Location

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

Debrecen, 4031, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 244707

Pécs, 7624, Hungary

Location

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

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

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

Warsaw, Masovian Voivodeship, 01-142, Poland

Location

High-Med Przychodnia Specjalistyczna /ID# 242973

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

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

Katowice, Silesian Voivodeship, 40-650, Poland

Location

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

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 21, 2022
• Study Start: March 16, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

PL (5); HU (4); DE (7); US (18); CA (4)