Sanofi has halted the Phase III MOBILIZE trial of riliprubart in CIDP after an independent interim analysis found the drug was unlikely to meet efficacy goals, though no safety concerns were observed. Other riliprubart studies, including the VITALIZE Phase III trial in IVIg-treated patients (NCT06290141), will continue while the company re-evaluates its programs. Sanofi will coordinate a careful wind-down of MOBILIZE, ensure patient care transitions, and analyze the data to guide future research.
Sanofi Halts Phase III MOBILIZE Trial of Riliprubart in CIDP After Interim Analysis Finds Low Efficacy
Sanofi has stopped the Phase III MOBILIZE study (NCT06290128) of riliprubart in chronic inflammatory demyelinating polyneuropathy (CIDP) after an independent interim analysis concluded the drug is unlikely to meet the study's efficacy thresholds. The independent data monitoring committee (IDMC) did not identify any safety signals related to riliprubart during the review.
What Happened
The MOBILIZE trial investigated riliprubart — an IgG4 humanised monoclonal antibody — in patients with CIDP who were refractory to standard-of-care (SoC) therapies (SoC includes treatments such as corticosteroids). Following the IDMC recommendation, Sanofi will wind down MOBILIZE and work with investigators and site teams to ensure appropriate transitions of care for enrolled patients.
Ongoing Programs and Next Steps
Sanofi said other clinical studies of riliprubart will continue, including the VITALIZE Phase III trial (NCT06290141), which is evaluating riliprubart in IVIg-treated CIDP patients. The company added that ongoing studies will be re-evaluated in light of the MOBILIZE findings, and it will perform a thorough analysis of the MOBILIZE data to inform future research and contribute to the broader scientific understanding of CIDP.
About Riliprubart and CIDP
Riliprubart selectively inhibits activated C1s proteases in the classical complement pathway, a mechanism intended to reduce complement-mediated inflammation. CIDP is a rare autoimmune disorder in which the immune system attacks the myelin sheath of peripheral nerves, causing progressive weakness and sensory loss in the arms and legs.
Prior Clinical Data
Phase II data had shown encouraging disease-controlling effects: after 24 weeks on riliprubart, 87% of SoC-treated subjects, 89% of SoC-refractory subjects, and 92% of SoC-naïve subjects demonstrated improvement or stable disease. Those earlier results supported further evaluation but were not predictive of MOBILIZE’s interim outcome.
Background: Sanofi gained riliprubart as part of its $11.6 billion acquisition of Bioverativ in March 2018. The initial report of the MOBILIZE stoppage was published by Clinical Trials Arena, a GlobalData-owned brand.
The information above is provided for general informational purposes and is not medical advice. Patients and clinicians should consult specialists before changing treatment plans.
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