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Also known as OnabotA X
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 being developed for aesthetic treatment of facial lines, specifically forehead lines and glabellar lines. It is an investigational injectable product studied in adult participants. AbbVie Inc. is developing it as a Phase 2 candidate in dermatology.
OnabotulinumtoxinA X targets SNAP25, a protein involved in neurotransmitter release at nerve terminals. It acts as an inhibitor of SNAP25. By targeting this protein, the drug is designed to reduce muscle contraction that contributes to facial lines such as forehead and glabellar lines.
OnabotulinumtoxinA X is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating the drug in adult participants with forehead lines and glabellar lines.
OnabotulinumtoxinA X is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 program includes completed trials in forehead lines and glabellar lines, with no active trials currently listed.
OnabotulinumtoxinA X has been studied in two completed Phase 2 trials. NCT05152576 evaluated the drug in 124 adults with forehead lines in the United States. NCT00199 assessed 328 adults with glabellar lines, also in the United States. Both were randomized, double-blind, and placebo-controlled.