Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABT-555
Elezanumab · 5 trials · 4 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. |
| Group 2 | EXPERIMENTAL | Participants will receive multiple doses of ABT-555 or placebo |
| Group 3 | EXPERIMENTAL | Participants will receive multiple doses of ABT-555 or placebo |
| Group 1 | EXPERIMENTAL | Participants will receive multiple doses of ABT-555 or placebo |
| Name | Type | Description |
|---|---|---|
| Elezanumab | DRUG | Intravenous (IV) infusion |
| Placebo | DRUG | Intravenous (IV) infusion |
| ABT-555 | DRUG | Intravenous 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 monoclonal antibody developed by AbbVie Inc. (ticker ABBV) for neurologic conditions. It has been studied in Phase 2 clinical trials for acute ischemic stroke, multiple sclerosis, and spinal cord injury. It is not approved and remains in clinical development.
Elezanumab targets RGMA, or repulsive guidance molecule A. It is an inhibitor of RGMA, meaning it is designed to block the activity of this target. RGMA is a protein involved in regulating neural repair and axon growth, which is the basis for studying elezanumab in neurologic injury and disease.
Elezanumab has been studied in clinical trials for three neurologic indications: acute ischemic stroke, multiple sclerosis, including relapsing and progressive forms, and acute traumatic cervical spinal cord injury. It is investigational and has not been approved for any indication.
Elezanumab is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating elezanumab in acute ischemic stroke, multiple sclerosis, and spinal cord injury.
Elezanumab is in Phase 2 clinical development. All of its reported trials were Phase 2 studies, and they have been completed. The drug is investigational and has not been approved by the FDA for any indication.
Elezanumab has been evaluated in completed Phase 2 trials including NCT04309474 in acute ischemic stroke, NCT04295538 in acute traumatic cervical spinal cord injury, and NCT03737851 and NCT03737812 in relapsing and progressive forms of multiple sclerosis. These studies were randomized, double-blind, and placebo-controlled.