Alexion CHAMPION-ALS study
Active but not recruiting anymore
Alexion CHAMPION-ALS study (“A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis”)
This global phase 3 study aims to assess the effect and safety of Ultomiris (ravulizumab) on disease progression in 354 patients with familial or sporadic ALS.
Ultomiris is a biological product, specifically a monoclonal antibody, designed to bind and inhibit the activity of the C5 protein, preventing overactivation of the complement system. There is evidence of potential benefit in ALS patients, as proteins of the complement system are involved in the onset of the disease and the progression of motor symptoms.
UZ Leuven included patients receiving regular intravenous infusions of ravulizumab or placebo for 50 weeks. The primary endpoint is to demonstrate a statistically significant difference between the two products on patient functioning measured by the ALSFRS-R scale (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale)
Initial results are expected in late 2022 and final results in late 2024.
Detailed information can be found at this link.