A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)

Phase 1

Recruiting

• Conditions: Glabellar Lines
• Interventions: Drug: AGN-151586; Drug: OnabotulinumtoxinA; Drug: Placebo

• Registration Number: NCT06834789
• Lead Sponsor: AbbVie

Brief Summary

The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study Start: 2025-02-18
• Study First Posted: 2025-02-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
• Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.

Exclusion Criteria

• Active infection or dermatological condition at the treatment injection sites.
• History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA	OnabotulinumtoxinA	Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA	OnabotulinumtoxinA	Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA	OnabotulinumtoxinA	Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA	AGN-151586	Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA	OnabotulinumtoxinA	Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: Placebo and OnabotulinumtoxinA	OnabotulinumtoxinA	Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.
Cohort 3: Placebo and OnabotulinumtoxinA	Placebo	Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA	AGN-151586	Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA	AGN-151586	Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA	AGN-151586	Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Up to approximately 10.4 months	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA	Up to approximately 10.4 months	Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.

Trial Locations

Locations (8)

Investigate MD /ID# 270771; 🇺🇸 Scottsdale, Arizona, United States

Marcus Facial Plastic Surgery /ID# 270770; 🇺🇸 Redondo Beach, California, United States

Skin Research Institute LLC /ID# 270831; 🇺🇸 Coral Gables, Florida, United States

Skincare Physicians /ID# 271018; 🇺🇸 Chestnut Hill, Massachusetts, United States

Wilmington Dermatology Center /ID# 270828; 🇺🇸 Wilmington, North Carolina, United States

Austin Institute for Clinical Research - Pflugerville /ID# 270834; 🇺🇸 Pflugerville, Texas, United States

SkinDC /ID# 270932; 🇺🇸 Arlington, Virginia, United States

Eye Research Foundation /ID# 270827; 🇺🇸 Newport Beach, California, United States