An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
Summary
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.
Timeline
- Start
- 2019-12-09
- Primary completion
- 2022-03-15
- Completion
- 2024-10-31
Outcome
Met primary endpoint
registry COUNT_OF_PARTICIPANTS Ravulizumab: 0 Participants NCT04201262 ↗
registry analysis (other test); Ravulizumab vs Placebo (ECU-NMO-301); p < 0.0001; Hazard Ratio (HR) 0.014 (95% CI 0.000 to 0.103); Log Rank NCT04201262 ↗
release “CHAMPION-NMOSD trial showed that Ultomiris (ravulizumab-cwvz) achieved a statistically significant and clinically meaningful reduction in the risk of relapse” astrazeneca.com ↗
release “Ultomiris , the first and only long-acting C5 complement inhibitor, met the primary endpoint of time to first on-trial relapse” astrazeneca.com ↗
release “Detailed positive results from the Phase III CHAMPION-NMOSD trial showed that Ultomiris (ravulizumab) significantly reduced relapse risk” astrazeneca.com ↗
release “In the CHAMPION-NMOSD trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial. Ultomiris met the primary endpoint” astrazeneca.com ↗
Publications
- Pittock SJ, Barnett MH, Bennett JL, Berthele A, de Seze J, Levy M, Nakashima I, Oreja-Guevara C, Palace J, Paul F, Pozzilli C, Pathak R, Allen K, Parks B, Kim HJ. Long-Term Ravulizumab Efficacy and Safety in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder: Final CHAMPION-NMOSD Results. Neurol Neuroimmunol Neuroinflamm. 2026 Sep;13(5):e200609. doi: 10.1212/NXI.0000000000200609. Epub 2026 Jul 13.
- Bennett JL, Bhattacharyya S, Zabeti A, Levy M, de Seze J, Taney MJ, Parks B, Allen K, Akpoji U, Pittock SJ. Safety and efficacy of ravulizumab in patients with NMOSD previously treated with rituximab: A post hoc analysis of the CHAMPION-NMOSD trial. Mult Scler. 2026 Apr;32(4):396-408. doi: 10.1177/13524585261425076. Epub 2026 Mar 4.
- Ortiz S, Pittock SJ, Berthele A, Levy M, Nakashima I, Oreja-Guevara C, Allen K, Mashhoon Y, Parks B, Kim HJ. Immediate and sustained terminal complement inhibition with ravulizumab in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. Front Neurol. 2024 Jan 31;15:1332890. doi: 10.3389/fneur.2024.1332890. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ravulizumab | Monoclonal antibody | — | Intravenous |