Ravulizumab-cwvz (Ultomiris®) reduces the risk of relapse in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD), according to results from an open-label phase 3 clinical trial called CHAMPION-NMOSD.
“These trial results show that Ultomiris may help patients move towards eliminating relapses, which is an important advancement in the treatment of NMOSD,” said Marc Dunoyer the chief executive officer of Alexion, the developers of the treatment, in a press release.
CHAMPION-NMOSD is an external placebo-controlled, open-label, multicenter study evaluating the safety and efficacy of ravulizumab in adults with NMOSD. During the primary treatment period, all participants receive the treatment via intravenous infusion.
After completion of the primary treatment period, all participants have the opportunity to continue receiving the treatment in a long-term extension period of the study for up to 2 years.
The primary endpoint is the time to first relapse. Secondary endpoints are the incidence of treatment-emergent adverse and serious adverse events, annualized relapse rate, and clinically important worsening on the Expanded Disability Status Scale.
The study already recruited 58 participants with NMSOD aged 18 years and older. It met its primary endpoint, with no relapses being observed in any of the patients over a median treatment duration of 73 weeks. The safety and tolerability of the treatment were consistent with previous studies and other approved indications, according to the company.
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The trial is ongoing with all but 2 patients continuing to receive treatment in the long-term extension period. The estimated completion date of the trial is July 31, 2024.
Ravulizumab is a long-acting C5 complement inhibitor. It is a modified version of eculizumab, with an increased half-life reducing the frequency of infusions needed. Eculizumab is approved by the US Food and Drug Administration (FDA) to treat NMOSD. Ravulizumab has not been approved by the FDA to treat NMOSD, but it is approved for other indications.
ULTOMIRIS® (ravulizumab-cwvz) met primary endpoint in CHAMPION-NMOSD phase III trial in adults with neuromyelitis optica spectrum disorder. News release. Alexion; May 5, 2022.
An efficacy and safety study of ravulizumab in adult participants with NMOSD. US National Library of Medicine. Last updated February 21, 2022. Accessed May 12, 2022.