nctId: NCT06290128 id: EFC17236 id: U1111-1295-5755 type: REGISTRY domain: ICTRP id: 2023-506503-26 type: REGISTRY domain: CTIS briefTitle: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work acronym: MOBILIZE overallStatus: RECRUITING date: 2024-04-09 date: 2026-02-03 date: 2027-10-12 date: 2024-03-04 date: 2024-03-28 name: Sanofi class: INDUSTRY briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blind treatment in part A and open-label treatment in Part B. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Riliprubart name: Placebo name: Riliprubart name: Placebo measure: Percentage of participants refractory to standard of care (SOC) experiencing a response measure: Percentage of participants randomized to riliprubart with lasting response measure: Percentage of participants randomized to placebo who experience a response measure: Percentage of participants randomized to riliprubart who experience a response measure: Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in Medical Research Council Sum Score (MRCSS) measure: Percentage of participants refractory to immunoglobulins experiencing a response measure: Change from baseline in the EuroQol 5 Dimension, 5Level Health Scale (EQ5D5L) measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) measure: Number of participants with treatmentemergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) measure: Incidence and titer of anti-riliprubart antibodies (ADA) measure: Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) measure: Incidence and titer of anti-riliprubart antibodies measure: Change from baseline in I RODS score measure: Change from baseline in adjusted INCAT score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in MRC-SS measure: Change from baseline in EQ-5D-5L score measure: Change from baseline in RT-FSS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alabama Neurology Associates Site Number : 8400019 status: RECRUITING city: Birmingham state: Alabama zip: 35209 country: United States lat: 33.52066 lon: -86.80249 hasResults: False