A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines

November 3, 2026 updated by: AbbVie

A Phase 2 Study to Evaluate the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA for the Treatment of Moderate to Severe Upper Facial Lines in Adults

The objective of this Phase 2 study is to assess the safety and efficacy of single treatment of trenibotulinumtoxinE and onabotulibumtoxinA combination in adult participants with moderate to severe upper facial lines. The study has two parts; Part 1 evaluates treatment for glabellar lines.

Study Overview

Status

Status

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

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 (Estimated)

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.
300

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 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Total Skin and Beauty Dermatology Center /ID# 284360
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Recruiting
        • Advanced Research Associates - Glendale /ID# 284389
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Eye Research Foundation /ID# 284401
      • Vista, California, United States, 92083
        • Recruiting
        • Pacific Clinical Innovations /ID# 284406
    • Connecticut
      • Westport, Connecticut, United States, 06880
        • Recruiting
        • DMR Research - Westport /ID# 286612
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20005
        • Recruiting
        • Sherber+Rad /ID# 286392
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Biomedical Clinical Research /ID# 284411
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Laser and Skin Surgery Center of Indiana /ID# 284383
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Coleman Center For Cosmetic Dermatologic Surgery /ID# 286405
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • DelRicht Research - Prytania Street - New Orleans /ID# 284416
      • New Orleans, Louisiana, United States, 70130
        • Recruiting
        • Etre, Cosmetic Dermatology And Laser Center /ID# 284390
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Recruiting
        • Maryland Dermatology Laser Skin and Vein Institute /ID# 285750
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Recruiting
        • Skincare Physicians /ID# 284415
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Clarkston Dermatology /ID# 284483
    • North Carolina
      • Wilmington, North Carolina, United States, 28403
        • Recruiting
        • Wilmington Dermatology Center /ID# 284385
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Private Practice - Dr. Brian S. Biesman /ID# 284417
    • Texas
      • Austin, Texas, United States, 78746
        • Recruiting
        • Westlake Dermatology Clinical Research Center /ID# 284374
      • College Station, Texas, United States, 77845
        • Recruiting
        • J and S Studies /ID# 285693
      • Dallas, Texas, United States, 75225
        • Recruiting
        • Dallas Center for Dermatology and Aesthetics /ID# 284356
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research - Pflugerville /ID# 284375
    • Virginia
      • Arlington, Virginia, United States, 22209
        • Recruiting
        • SkinDC /ID# 284403

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For glabellar lines (GL) indication: participant must have moderate or severe GL at maximum furrow as assessed by both the investigator and participant using the AGLSS at Screening and Baseline (Day 1) visits.
  • Participant must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead electrocardiogram (ECG) parameters, clinical laboratory evaluations, and neurological assessment.
  • In the investigator's opinion, participant must not have a condition or be in a situation that may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Exclusion Criteria:

  • For GL Indication: Severe GL at rest as assessed by the investigator using the AGLSS at Screening or Baseline (Day 1).
  • 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
  • Active infection or dermatological condition at the treatment injection sites.
  • Medical condition that may put the subject at increased medical risk with exposure to botulinum toxin, including diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function

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: Triple

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: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8

Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

Injection
Active Comparator: OnabotulinumtoxinA

Participants will receive a single treatment of onabotulinumtoxinA.
Drug: OnabotulinumtoxinA

Injection
Placebo Comparator: Placebo

Participants will receive a single treatment of placebo.
Drug: Placebo

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 Day 150

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 Day 150
Percentage of Participants Achieving None or Mild on the Investigator-Assessed Allergan Glabellar Lines Severity Scale (AGLSS)
Time Frame: Day 7

Achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity.
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Time Frame: Day 7

Achievement of None or Mild on the subject-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity.
Day 7
Duration Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Time Frame: Up to Day 150

Duration AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the duration of treatment effect over time.
Up to Day 150
Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Time Frame: Up to to Day 7

Onset AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the rapidity of onset of treatment effect.
Up to to Day 7

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

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.
October 8, 2026

Primary Completion (Estimated)

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.
June 1, 2028

Study Completion (Estimated)

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.
June 1, 2028

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).
October 7, 2026

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.
October 7, 2026

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.
October 13, 2026

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 5, 2026

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 3, 2026

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, 2026

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.
  • M26-312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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