Sanofi announced that the riliprubart MOBILIZE phase 3 study (clinical study identifier: NCT06290128) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care treatment will be stopped. This decision follows an interim analysis by an independent data monitoring committee, which determined that the MOBILIZE study is unlikely to provide sufficient efficacy. No safety signals related to riliprubart were identified as part of this interim analysis.
The continuation of other ongoing studies with riliprubart, including the VITALIZE phase 3 study (clinical study identifier: NCT06290141) in IVIg-treated patients with CIDP, will be evaluated accordingly. Sanofi will work closely with investigators and site teams to ensure a wind-down of the MOBILIZE study, with appropriate transition of care for all enrolled patients. Sanofi will conduct a thorough analysis of the MOBILIZE data to inform future research directions and contribute to the broader scientific understanding of CIDP.
The termination of the MOBILIZE phase 3 study will not incur any significant financial cost. There is no change to the financial guidance for 2026. Riliprubart (SAR445088, BIVV020) is an IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system.
By blocking C1s, riliprubart has the potential to inhibit key inflammatory mechanisms that drive demyelination and axonal damage in CIDP. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
