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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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