Upper Facial LinesPhase 2NCT07871513
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 study testing TrenibotulinumtoxinE and OnabotulinumtoxinA and OnabotulinumtoxinA in people with Upper Facial Lines and Glabellar Lines, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Facial Lines, Glabellar Lines
- What is being tested?
- TrenibotulinumtoxinE and OnabotulinumtoxinA and OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2026to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advanced Research Associates - Glendale /ID# 284389
Glendale, Arizona, 85308
About this study
Official title: 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.
- Conditions
- Upper Facial Lines, Glabellar Lines
- Being tested
- TrenibotulinumtoxinE and OnabotulinumtoxinA, Placebo, OnabotulinumtoxinA
- Keywords
- Upper Facial Lines, Glabellar Lines, TrenibotulinumtoxinE, OnabotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrenibotulinumtoxinE and OnabotulinumtoxinADrug
Injection
PlaceboDrug
Injection
OnabotulinumtoxinADrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8 | Experimental | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. Receives: Drug: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| OnabotulinumtoxinA | Active comparator | Participants will receive a single treatment of onabotulinumtoxinA. Receives: Drug: OnabotulinumtoxinA |
| Placebo | Placebo comparator | Participants will receive a single treatment of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 150
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.
Measured: Day 7
Secondary outcomes (3)
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.
Measured: Day 7
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.
Measured: 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
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.
Measured: Up to to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start7 Oct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Facial LinesStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871513
- Sponsor's protocol ID
- M26-312
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.