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Monoclonal Antibodies
A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 60
Summary
This trial is testing a new treatment called AGN-151586, followed by BOTOX, for adults with deep wrinkles between their eyebrows. The treatment works by relaxing facial muscles to reduce wrinkles. Participants will receive injections and be monitored for safety and effectiveness over time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants achieving "none" or "mild" on the Facial Wrinkle Scale (FWS) according to the investigator assessment of Glabellar Lines (GL) severity at maximum frown
Side effects data
From 2023 Phase 3 trial • 638 Patients • NCT052488676%
HEADACHE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AGN-151586
Placebo/None
Placebo/AGN-151586
AGN-151586/None
AGN-151586/AGN-151586
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo, BOTOXExperimental Treatment2 Interventions
Participants will receive 5 intramuscular injections of placebo in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Group II: AGN-151586, BOTOXExperimental Treatment2 Interventions
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BOTOX
2013
Completed Phase 4
~1410
AGN-151586
2022
Completed Phase 3
~2250
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,954 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,603 Total Patients Enrolled