nctId: NCT06290141 id: EFC18156 id: U1111-1295-3363 type: REGISTRY domain: ICTRP 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-11-05 date: 2027-05-19 date: 2024-03-04 date: 2024-03-29 name: Sanofi class: INDUSTRY 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. conditions: Chronic Inflammatory Demyelinating Polyneuropathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part A is a double-blind treatment period and Part B is an open-label period. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: riliprubart name: Placebo name: riliprubart name: Placebo name: IVIg name: Placebo name: IVIg premedication measure: Percentage of participants experiencing a response measure: Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period measure: Change from baseline in Rasch-built Overall Disability Scale (I-RODS) 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 (MRC-SS) measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) measure: Percentage of participants experiencing a relapse measure: Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L) measure: Number of participants with TEAEs, including SAEs and AESIs measure: Number of participants with treatment-emergent ADA in participants treated with riliprubart measure: Number of participants with TEAEs, including SAEs and AESIs measure: Percentage of participants randomized to riliprubart experiencing a relapse measure: Percentage of participants randomized to IVIg continuation experiencing a relapse measure: Number of participants and titer of anti-drug antibodies (ADA) measure: Change from baseline in I-RODS 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 RT-FSS measure: Change from baseline in EQ-5D-5L score 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) measure: Percentage of participants randomized to IVIg continuation who experience a response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False