ClinicalTrials.gg
RecruitingNCT07871513Updated Oct 13, 2026

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

A Phase 2 interventional study of TrenibotulinumtoxinE and OnabotulinumtoxinA and Placebo in Upper Facial Lines and Glabellar Lines, sponsored by AbbVie. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Upper Facial Lines
  • Glabellar Lines

Keywords

  • Upper Facial Lines
  • Glabellar Lines
  • TrenibotulinumtoxinE
  • OnabotulinumtoxinA
03

In context

Lead sponsor

AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Experimental
    TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8

    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.

    Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA

  • Active comparator
    OnabotulinumtoxinA

    Participants will receive a single treatment of onabotulinumtoxinA.

    Drug: OnabotulinumtoxinA

  • Placebo comparator
    Placebo

    Participants will receive a single treatment of placebo.

    Drug: Placebo

Interventions

  • DrugTrenibotulinumtoxinE and OnabotulinumtoxinA

    Injection

  • DrugPlacebo

    Injection

  • Injection

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    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.

    Time frame: Up to Day 150

  2. Percentage of Participants Achieving None or Mild on the Investigator-Assessed Allergan Glabellar Lines Severity Scale (AGLSS)

    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.

    Time frame: Day 7

Secondary outcomes

  1. Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS

    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.

    Time frame: Day 7

  2. Duration Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS

    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.

    Time frame: Up to Day 150

  3. Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS

    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.

    Time frame: Up to to Day 7

07

Study locations

1 of 1 sites recruiting
  • Advanced Research Associates - Glendale /ID# 284389
    Glendale, Arizona 85308, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

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

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

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartEst.
Oct 7, 2026
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871513
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Oct 7, 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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