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)

November 14, 2025 updated by: AbbVie

A Phase 1 Study to Evaluate the Safety and Efficacy of Co-administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Investigate MD /ID# 270771
    • California
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation /ID# 270827
      • Redondo Beach, California, United States, 90277
        • Marcus Facial Plastic Surgery /ID# 270770
    • Florida
      • Coral Gables, Florida, United States, 33146-1837
        • Skin Research Institute LLC /ID# 270831
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Skincare Physicians /ID# 271018
    • North Carolina
      • Wilmington, North Carolina, United States, 28403
        • Wilmington Dermatology Center /ID# 270828
    • Texas
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research - Pflugerville /ID# 270834
    • Virginia
      • Arlington, Virginia, United States, 22209
        • SkinDC /ID# 270932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA
Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Drug: AGN-151586
Intramuscular injection
Drug: OnabotulinumtoxinA
Intramuscular injection
Experimental: Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA
Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Drug: AGN-151586
Intramuscular injection
Drug: OnabotulinumtoxinA
Intramuscular injection
Experimental: Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA
Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Drug: AGN-151586
Intramuscular injection
Drug: OnabotulinumtoxinA
Intramuscular injection
Experimental: Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA
Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Drug: AGN-151586
Intramuscular injection
Drug: OnabotulinumtoxinA
Intramuscular injection
Experimental: Cohort 3: Placebo and OnabotulinumtoxinA
Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.
Drug: Placebo
Intramuscular injection
Drug: OnabotulinumtoxinA
Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: 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.
Up to approximately 10.4 months
Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA
Time Frame: 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.
Up to approximately 10.4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Actual)

November 3, 2025

Study Completion (Actual)

November 3, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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