Discontinued

Alexion CHAMPION-ALS study (“A Phase 3, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Multicentre 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 biologic 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 complement system proteins are involved in disease onset and progression of motor symptoms.

UZ Leuven included patients receiving regular intravenous infusion of ravulizumab or placebo for 50 weeks. The primary endpoint was 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)

First results are expected by the end of 2022 and final results by the end of 2024.

Detailed information can be found at this link.