A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
Part of paid clinical trials in Lincolnshire, Illinois.
- Sponsor
- AbbVie
- Study ID
- NCT07756580
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Glabellar Lines
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AGN-151586 — DRUGInjection
- BOTOX — DRUGInjection
Study Details
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL. AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States. Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.
Key Dates
- First listed
- Aug 10, 2026
- Start date
- Aug 10, 2026
- Status verified
- Aug 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1 - AGN-151586 and BOTOXParticipants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.
- Experimental: Cohort 2 - AGN-151586 and BOTOXParticipants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.
Primary Outcome Measure
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Day 141 ]
Central Contacts
- ABBVIE CALL CENTER844-663-3742
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advanced Dermatology - Lincolnshire /ID# 284012 | Lincolnshire | Illinois | 60069 | - |