Approval Probability
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Also known as Elezanumab
ABT-555 · 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...
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ABT-555 is an investigational small molecule being developed for the treatment of Multiple Sclerosis. It is currently in Phase 1 clinical development, with a completed study in subjects with relapsing forms of Multiple Sclerosis. The drug is not yet approved and remains under investigation.
ABT-555 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Multiple Sclerosis.
ABT-555 is in Phase 1 clinical development. A Phase 1 study has been completed, but the drug is still investigational and has not received regulatory approval. It is being studied for the treatment of relapsing forms of Multiple Sclerosis.
ABT-555 has one completed clinical trial, registered as NCT02601885, titled "A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis." This Phase 1 study enrolled 20 participants in the United States and was a randomized, double-blind, controlled trial.
ABT-555 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Multiple Sclerosis. The completed Phase 1 trial, NCT02601885, was designed to evaluate the drug's safety and tolerability, but further studies are needed before any approval consideration.