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)

NCT ID: NCT06834789

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2025-11-03

Brief Summary

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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

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA

Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

Intramuscular injection

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular injection

Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA

Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

Intramuscular injection

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular injection

Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA

Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

Intramuscular injection

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular injection

Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA

Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

Intramuscular injection

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular injection

Cohort 3: Placebo and OnabotulinumtoxinA

Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular injection

Placebo

Intervention Type DRUG

Intramuscular injection

Interventions

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AGN-151586

Intramuscular injection

Intervention Type DRUG

OnabotulinumtoxinA

Intramuscular injection

Intervention Type DRUG

Placebo

Intramuscular injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Investigate MD /ID# 270771

Scottsdale, Arizona, United States

Site Status

Eye Research Foundation /ID# 270827

Newport Beach, California, United States

Site Status

Marcus Facial Plastic Surgery /ID# 270770

Redondo Beach, California, United States

Site Status

Skin Research Institute LLC /ID# 270831

Coral Gables, Florida, United States

Site Status

Skincare Physicians /ID# 271018

Chestnut Hill, Massachusetts, United States

Site Status

Wilmington Dermatology Center /ID# 270828

Wilmington, North Carolina, United States

Site Status

Austin Institute for Clinical Research - Pflugerville /ID# 270834

Pflugerville, Texas, United States

Site Status

SkinDC /ID# 270932

Arlington, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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M25-207

Identifier Type: -

Identifier Source: org_study_id

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