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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
AbbVie
Study ID
NCT07871513
Phase
PHASE2
Status
Recruiting
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Conditions

  • Glabellar Lines
  • Upper Facial Lines

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TrenibotulinumtoxinE and OnabotulinumtoxinA — DRUG
    Injection
  • Placebo — DRUG
    Injection
  • OnabotulinumtoxinA — DRUG
    Injection

Study Details

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.

Key Dates

First listed
Oct 13, 2026
Start date
Oct 7, 2026
Status verified
Oct 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Experimental: TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8
    Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA.
  • Active Comparator: OnabotulinumtoxinA
    Participants will receive a single treatment of onabotulinumtoxinA.
  • Placebo Comparator: Placebo
    Participants will receive a single treatment of placebo.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Day 150 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advanced Research Associates - Glendale /ID# 284389GlendaleArizona85308-

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Advanced Research Associates - Glendale· Glendale, AZ

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