A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)

NCT06834789
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Phase
Phase 1
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Recruitment status
Completed
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Participants
132
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Lead sponsor
AbbVie
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Start date
2025-02-18
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Number of sites
8
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Summary
The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).
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Short title
A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)
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Official title
A Phase 1 Study to Evaluate the Safety and Efficacy of Co-administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-11-03
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First posted
2025-02-19
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Registry last updated
2025-11-17
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Primary completion date
2025-11-03
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Start date
2025-02-18
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Actual participants
132
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Participants
132
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
8
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06834789
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ClinicalTrials.gov ID
NCT06834789
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. Number of Participants with Adverse Events (AEs)

    Timeframe: Up to approximately 10.4 months

    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.

  2. Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA

    Timeframe: Up to approximately 10.4 months

    Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
  • Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.

  • Active infection or dermatological condition at the treatment injection sites.
  • 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, and/or other products in the same class.
Sources for eligibility
clinicaltrials.gov

  • Investigate MD /ID# 270771Scottsdale, United States
  • Eye Research Foundation /ID# 270827Newport Beach, United States
  • Marcus Facial Plastic Surgery /ID# 270770Redondo Beach, United States
  • Skin Research Institute LLC /ID# 270831Coral Gables, United States
  • Skincare Physicians /ID# 271018Chestnut Hill, United States
  • Wilmington Dermatology Center /ID# 270828Wilmington, United States
  • Austin Institute for Clinical Research - Pflugerville /ID# 270834Pflugerville, United States
  • SkinDC /ID# 270932Arlington, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (1)