Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OnabotulinumtoxinA X · 2 trials · 2 indications
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 casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the 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.
Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.
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
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo will be injected into the forehead on Day 1. |
| OnabotulinumtoxinA X Dose A | EXPERIMENTAL | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| OnabotulinumtoxinA X Dose B | EXPERIMENTAL | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| OnabotulinumtoxinA X Dose C | EXPERIMENTAL | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| Name | Type | Description |
|---|---|---|
| OnabotulinumtoxinA X | DRUG | Intramuscular Injection |
| Placebo | DRUG | Intramuscular Injection |
Inclusion Criteria: * Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines * Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation Exclusion Criteria: * History of known immun...
OnabotulinumtoxinA X is an investigational small molecule being developed for the treatment of glabellar lines and forehead lines, which are types of facial wrinkles. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
OnabotulinumtoxinA X is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
OnabotulinumtoxinA X is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, one for glabellar lines and one for forehead lines.
OnabotulinumtoxinA X has completed two Phase 2 trials. NCT05100199 assessed the change in condition and adverse events in 328 adult participants with glabellar lines. NCT05152576 assessed adverse effects and change in condition in 124 adult participants with forehead lines. Both trials were conducted in the United States.
OnabotulinumtoxinA X is a distinct investigational product being developed by AbbVie. It is not the same as Botox, which is an approved formulation of onabotulinumtoxinA. OnabotulinumtoxinA X is still in clinical trials and has not been approved for any use.