protocolSection identificationModule nctId: NCT06290141, orgStudyIdInfo id: EFC18156, secondaryIdInfos id: U1111-1295-3363, type: REGISTRY, domain: ICTRP, secondaryIdInfos id: 2023-508338-33, type: REGISTRY, domain: CTIS, briefTitle: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), acronym: VITALIZE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-11-05, completionDateStruct date: 2027-05-19, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up., conditionsModule conditions: Chronic Inflammatory Demyelinating Polyneuropathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Part A is a double-blind treatment period and Part B is an open-label period., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: riliprubart, interventions name: Placebo, interventions name: riliprubart, interventions name: Placebo, interventions name: IVIg, interventions name: Placebo, interventions name: IVIg premedication, outcomesModule primaryOutcomes measure: Percentage of participants experiencing a response, primaryOutcomes measure: Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period, secondaryOutcomes measure: Change from baseline in Rasch-built Overall Disability Scale (I-RODS) 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 (MRC-SS), secondaryOutcomes measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), secondaryOutcomes measure: Percentage of participants experiencing a relapse, secondaryOutcomes measure: Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), secondaryOutcomes measure: Number of participants with TEAEs, including SAEs and AESIs, secondaryOutcomes measure: Number of participants with treatment-emergent ADA in participants treated with riliprubart, secondaryOutcomes measure: Number of participants with TEAEs, including SAEs and AESIs, secondaryOutcomes measure: Percentage of participants randomized to riliprubart experiencing a relapse, secondaryOutcomes measure: Percentage of participants randomized to IVIg continuation experiencing a relapse, secondaryOutcomes measure: Number of participants and titer of anti-drug antibodies (ADA), secondaryOutcomes measure: Change from baseline in I-RODS, 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 RT-FSS, secondaryOutcomes measure: Change from baseline in EQ-5D-5L score, secondaryOutcomes measure: Percentage of participants randomized to riliprubart who experience a response during the open-label period without prior response in the double-blind period (delayed response), secondaryOutcomes measure: Percentage of participants randomized to IVIg continuation who experience a response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False