Clinical trial NCT05248867: A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
Official title: A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Keywords: Glabellar Lines
AGN-151586
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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]
timeFrame: Baseline, Day 7 (Double-blind period)
measure: 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]
timeFrame: Baseline, Day 7 (Double-blind period)
measure: 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]
timeFrame: Baseline, Day 7 (Double-blind Period)
measure: Number of Participants With Adverse Events
timeFrame: 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:
measure: 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]
timeFrame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
measure: 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]
timeFrame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
measure: 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]
timeFrame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
measure: 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]
timeFrame: Day 7 (Double-blind Period)
measure: 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]
timeFrame: Hour 24 (Double-blind Period)
measure: Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA]
timeFrame: Day 7 (Double-blind Period)
measure: Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies]
timeFrame: Baseline, Day 7 (Double-blind Period)
measure: Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
timeFrame: Baseline, Hour 24 (Double-blind Period)
measure: Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
timeFrame: Baseline, Hour 24 (Double-blind Period)
measure: Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
timeFrame: Baseline, Hour 24 (Double-blind Period)
measure: Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
timeFrame: Baseline, Hour 24 (Double-blind Period)
measure: 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 [European Union Regulatory Agencies]
timeFrame: Hour 24 (Double-blind Period)
measure: Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies]
timeFrame: Day 7 (Double-blind Period)
measure: Time to the First ≥ 1-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies]
timeFrame: From Baseline to Day 43 (Double-blind Period)
measure: Time to the First ≥1-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies]
timeFrame: From Baseline to Day 43 (Double-blind Period)
measure: Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies]
timeFrame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period)
measure: Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies]
timeFrame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period)
measure: Time to Return to Baseline FWS According to Participant Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies]
timeFrame: From Baseline to Day 43 (Double-blind Period)
measure: Time to Return to Baseline FWS According to Investigator Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies]
timeFrame: From Baseline to Day 43 (Double-blind Period)
measure: 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 Over Time [European Union Regulatory Agencies]
timeFrame: Baseline, Hours 8, 24, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
measure: Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies]
timeFrame: Baseline, Day 7 (Double-blind Period)
measure: Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies]
timeFrame: Baseline, Day 7 (Double-blind Period)
measure: Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies]
timeFrame: Hours 24 and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Derm Ctr /ID# 232378
state: Alabama
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills /ID# 233195
state: California
city: Los Angeles
country: United States
facility: Westside Aesthetics /ID# 232443
state: California
city: San Francisco
country: United States
facility: The Research Center at The Maas Clinic /ID# 241262
state: California
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery /ID# 232315
state: District of Columbia
city: Boca Raton
country: United States
facility: Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232439
state: Florida
city: Baton Rouge
country: United States
facility: Dermatology Clinic & Cosmetic Center /ID# 244295
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research /ID# 241253
state: Louisiana
city: Chestnut Hill
country: United States
facility: Skincare Physicians /ID# 233938
state: Massachusetts
city: Birmingham
country: United States
facility: BOYD Beauty Birmingham /ID# 232383
state: Michigan
city: Rochester
country: United States
facility: Skin Search of Rochester Inc. /ID# 232549
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions /ID# 232389
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Dublin /ID# 233936
state: Ohio
city: Newtown Square
country: United States
facility: KGL Skin Study Center, LLC /ID# 233549
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery /ID# 242535
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232410
state: Texas
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 232328
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research at SBA Dermatology /ID# 232316
state: Texas
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 233227
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre /ID# 241172
state: Alberta
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 241863
state: Ontario
city: Westmount
country: Canada
facility: Erevna Innovations Inc. /ID# 239592
state: Quebec
city: Muenchen
country: Germany
facility: Studienzentrum Theatiner46 /ID# 241185
state: Bayern
city: Darmstadt
country: Germany
facility: Rosenpark Research /ID# 232391
state: Hessen
city: Duesseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner /ID# 232392
state: Nordrhein-Westfalen
city: Kassel
country: Germany
facility: Noahklinik GmbH /ID# 241184
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics /ID# 232393
city: Muenchen
country: Germany
facility: Privatpraxis fuer Dermatologie und Aesthetik /ID# 241544
city: Oberursel
country: Germany
facility: MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 241186
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 244708
state: Csongrad
city: Kaposvár
country: Hungary
facility: Derm-Surg Kft. /ID# 244709
state: Somogy
city: Debrecen
country: Hungary
facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 244706
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 244707
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o /ID# 242972
state: Lodzkie
city: Oswiecim
country: Poland
facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 242990
state: Malopolskie
city: Warsaw
country: Poland
facility: Clinical Research Group Sp. z o.o. /ID# 242988
state: Mazowieckie
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistyczna /ID# 242973
state: Mazowieckie
city: Katowice
country: Poland
facility: Novo-Med Zielinski i Wspolnicy Spolka Jawna /ID# 242986
state: Slaskie
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: