Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis
Summary
This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of approximately 294 eligible subjects will be randomised from approximately 37 centers worldwide. The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed.
Timeline
- Start
- 2012-12-20
- Primary completion
- 2015-01-22
- Completion
- 2015-01-22
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Ozanezumab 15 mg/kg; p = 0.120; Mean Difference (Final Values) -30.0 (95% CI -67.9 to 7.9); ANCOVA NCT01753076 ↗
paper INTERPRETATION: Ozanezumab did not show efficacy compared with placebo in patients with ALS. PMID 28139349 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ozanezumab | Monoclonal antibody | 15 mg/kg | Intravenous |