Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elezanumab · 4 trials · 3 indications
The National Institutes of Health Stroke Scale (NIHSS) is a neurological examination used to quantitatively measure the severity of acute stroke by evaluating impact of cerebral infarction on level of consciousness, gaze, visual field, facial palsy, motor ability of arm and leg, limb ataxia, sensation, language, dysarthria, and extinction/inattention. Domains are scored on a scale of 0 to 2, 0 to 3, or 0 to 4, for a total range of 0 to 42 points with higher scores indicating impairment. The monthly-adjusted AUC of the NIHSS total score for each treatment group was derived using the trapezoidal method and contrasts from a Mixed Model with Repeated Measures (MMRM). Please refer to the formula for AUCi in the Statistical Analysis Plan (SAP) where i = treatment group (placebo, elezanumab) and j = visit during the Treatment Period {Day 1, Day 2-4, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52}.
The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively.
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 ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
| Arm | Type | Description |
|---|---|---|
| Elezanumab | EXPERIMENTAL | Participants will receive elezanumab 1800 mg |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo for elezanumab |
| Elezanumab 400mg Dose | EXPERIMENTAL | Participants randomized to receive 400mg of elezanumab by intravenous infusion. |
| Elezanumab 1800 mg Dose | EXPERIMENTAL | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. |
| Elezanumab Dose 1 | EXPERIMENTAL | Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion. |
| Elezanumab Dose 2 | EXPERIMENTAL | Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| Elezanumab | DRUG | Intravenous (IV) infusion |
| Placebo | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * Clinical diagnosis of acute ischemic stroke, supported by acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis. * Able to randomize within 24 hours of last known normal. * National Institute of Health Stroke Scale (NIH...
Elezanumab is an investigational small molecule being developed for neurological conditions, including acute ischemic stroke, spinal cord injury (SCI), and multiple sclerosis (MS). It is administered intravenously and has been studied in Phase 2 clinical trials for these indications.
Elezanumab is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie has sponsored multiple clinical trials evaluating the drug's safety and efficacy in neurological disorders.
Elezanumab is in Phase 2 clinical development. It has completed four Phase 2 trials, with no active trials currently enrolling. The drug remains investigational and has not been approved by regulatory authorities for any indication.
Elezanumab has completed four Phase 2 trials: NCT03737812 and NCT03737851 in multiple sclerosis, NCT04295538 in spinal cord injury, and NCT04309474 in acute ischemic stroke. These trials were randomized, double-blind, and placebo-controlled, enrolling a total of 331 participants.
Elezanumab is a small molecule that targets a specific molecular pathway involved in neurological damage and repair. By modulating this target, it aims to reduce injury and promote functional recovery in conditions like stroke, spinal cord injury, and multiple sclerosis.
No alternative names for Elezanumab have been reported. It is identified solely by its generic name and is being developed exclusively by AbbVie for neurological indications.