Clinical trial NCT06151561: Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines
Official title: A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatment of Japanese Subjects With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moderate to Severe Glabellar Lines
Keywords: Glabellar Lines, AGN-151586
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: 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. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe GL in Japanese participants.

AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan.

Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Participants must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
* Participants must have moderate or severe GL at maximum frown as assessed by the investigator using the FWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.

Exclusion Criteria:

* Participants must not have uncontrolled systemic disease.
* History of known immunization to any botulinum neurotoxin serotype
* 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 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 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.
* 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 >= 2-grade improvement from baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide according to investigator assessment of Glabellar Lines (GL) severity at maximum frown, at any timepoint through Day 7
timeFrame: Baseline (Day 1) through Day 7
Secondary outcomes:
measure: Percentage of participants with a >= 2-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time
timeFrame: Baseline (Day 1) through End of Study (Up to Day 42)
measure: Percentage of participants with a >= 1-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time
timeFrame: Baseline (Day 1) through End of Study (Up to Day 42)
measure: Percentage of participants with a None or Mild on the FWS-A according to investigator assessment of GL severity at maximum frown over time
timeFrame: Baseline (Day 1) through End of Study (Up to Day 42)
Other outcomes:
Locations:
city: Central District
country: Japan
facility: Tokyo Center Clinic /ID# 257898
state: Tokyo
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: