A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Study Overview
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Brief Summary
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This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines

Conditions
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Glabellar Lines

Intervention / Treatment
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* Drug: OnabotulinumtoxinA X
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator. Participant has moderate or severe GL at maximum frown. Exclusion Criteria: History of known immunization to any botulinum toxin serotype. History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class. Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including: Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function. Facial nerve palsy. Infection or dermatological condition at the site of study drug injection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo will be injected into the Glabellar Complex on Day 1. | Drug: Placebo<br>* Injection<br>|
| Experimental: OnabotulinumtoxinA X Dose A<br>OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1. | Drug: OnabotulinumtoxinA X<br>* Injection<br>|
| Experimental: OnabotulinumtoxinA X Dose B<br>OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1. | Drug: OnabotulinumtoxinA X<br>* Injection<br>|
| Experimental: OnabotulinumtoxinA X Dose C<br>OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1. | Drug: OnabotulinumtoxinA X<br>* Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale. | The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe | Day 1 to Day 30 | 
| Percentage of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | Day 1 to Day 270 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale. | The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe | Day 1 to Day 30 | 
| Percentage of Participants with Achievement of improvement per the Facial Lines Satisfaction Questionnaire Impact domain, among subjects with baseline scores of 14 points or greater. | The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. | Day 1 to Day 30 | 
| Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5. | The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. | Day 1 to Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OnabotulinumtoxinA X, BOTOX, Glabellar Lines