Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease. It is currently in Phase 2 clinical development and is not approved by regulatory authorities.
Ozanezumab is being developed by GSK plc, a global pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company sponsored a Phase 2 clinical trial of the drug in patients with ALS.
Ozanezumab is in Phase 2 clinical development. One Phase 2 trial has been completed, and there are no active trials currently enrolling. The drug remains investigational and has not received regulatory approval for any indication.
Ozanezumab has one completed clinical trial, identified as NCT01753076. This Phase 2 study compared Ozanezumab (also known as GSK1223249) against placebo in 304 patients with Amyotrophic Lateral Sclerosis across multiple countries, including the United States, Australia, and European nations.
Yes, Ozanezumab is also known as GSK1223249. The clinical trial NCT01753076, which evaluated the drug in Amyotrophic Lateral Sclerosis, used this alternative name to identify the investigational treatment in its official title.