protocolSection identificationModule nctId: NCT06290128, orgStudyIdInfo id: EFC17236, secondaryIdInfos id: U1111-1295-5755, type: REGISTRY, domain: ICTRP, secondaryIdInfos 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-02-03, completionDateStruct date: 2027-10-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double-blind treatment in part A and open-label treatment in Part B., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Riliprubart, interventions name: Placebo, interventions name: Riliprubart, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of participants refractory to standard of care (SOC) experiencing a response, primaryOutcomes measure: Percentage of participants randomized to riliprubart with lasting response, primaryOutcomes measure: Percentage of participants randomized to placebo who experience a response, primaryOutcomes measure: Percentage of participants randomized to riliprubart who experience a response, secondaryOutcomes measure: Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score, secondaryOutcomes measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, secondaryOutcomes measure: Change from baseline in grip strength (kilopascals; dominant hand), secondaryOutcomes measure: Change from baseline in Medical Research Council Sum Score (MRCSS), secondaryOutcomes measure: Percentage of participants refractory to immunoglobulins experiencing a response, secondaryOutcomes measure: Change from baseline in the EuroQol 5 Dimension, 5Level Health Scale (EQ5D5L), secondaryOutcomes measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), secondaryOutcomes measure: Number of participants with treatmentemergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs), secondaryOutcomes measure: Incidence and titer of anti-riliprubart antibodies (ADA), secondaryOutcomes measure: Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), secondaryOutcomes measure: Incidence and titer of anti-riliprubart antibodies, secondaryOutcomes measure: Change from baseline in I RODS score, secondaryOutcomes measure: Change from baseline in adjusted INCAT score, secondaryOutcomes measure: Change from baseline in grip strength (kilopascals; dominant hand), secondaryOutcomes measure: Change from baseline in MRC-SS, secondaryOutcomes measure: Change from baseline in EQ-5D-5L score, secondaryOutcomes measure: Change from baseline in RT-FSS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alabama Neurology Associates Site Number : 8400019, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35209, country: United States, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False