Approval Probability
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Ozanezumab · 1 trial · 1 indication
The joint rank score is a combined assessment of function and survival. Function is assessed using change from Baseline in the ALSFRS-R total score. To calculate joint rank scores, every participant was compared with all other participants in a pair wise manner and assigned a score of -1, 0 or 1 based on their relative outcomes. A subject's joint rank score is the sum of their scores across the pair wise comparisons. The . The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing. Lower scores of ALSFRS-R reflect greater impairment.
| Arm | Type | Description |
|---|---|---|
| Ozanezumab IV | EXPERIMENTAL | Administered by IV route. Treatment period - 48 Weeks |
| Placebo | PLACEBO_COMPARATOR | Normal saline by IV route. Treatment period - 48 weeks |
| Name | Type | Description |
|---|---|---|
| Ozanezumab | DRUG | Ozanezumab injection solution |
| Placebo | DRUG | Normal saline (0.9% sodium chloride) infusion |
Inclusion Criteria: * Patients with diagnosis of familial or sporadic ALS * Onset of muscle weakness no more than 30 months before screening visit. * Slow Vital Capacity (SVC) of at least 65% predicted for gender, age, ethnicity and height at Screening. * If on riluzole, the dose must have been sta...
Ozanezumab is an investigational monoclonal antibody developed by GSK plc for amyotrophic lateral sclerosis (ALS), a progressive neurological disease. It is not approved and remains in clinical development, having completed a Phase 2 trial. GSK1223249 is another designation used for this same antibody candidate.
Ozanezumab was studied as a treatment for amyotrophic lateral sclerosis, a neurological condition affecting motor neurons. It was evaluated in adults 18 years and older with ALS. The program reached Phase 2, and the drug is investigational rather than approved for any indication.
Ozanezumab targets RTN4, also known as Nogo-A, and acts as an inhibitor of that target. RTN4 is a protein associated with inhibition of nerve fiber growth. By binding and inhibiting RTN4, the antibody was designed to address a mechanism thought relevant to motor neuron disease in ALS.
Ozanezumab is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical program for the antibody, including the Phase 2 study conducted across multiple countries. The compound is also referenced by the code GSK1223249.
Ozanezumab is in Phase 2, and it is investigational rather than approved. One Phase 2 trial has been completed, and no trials are currently active. The completed study was randomized, double-blind, and placebo-controlled, enrolling 304 participants with amyotrophic lateral sclerosis.
Ozanezumab was evaluated in the Phase 2 trial NCT01753076, titled Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis. That trial is completed and enrolled 304 participants across the United States, Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, South Korea, and the United Kingdom.