Skip to content

A Phase 3, double-blind, placebo-controlled study evaluating efficacy and safety of riliprubart in participants with refractory chronic inflammatory demyelinating polyneuropathy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506503-26-00
Acronym
EFC17236
Enrollment
82
Registered
2024-06-17
Start date
2024-07-31
Completion date
Unknown
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic, Inflammatory Demyelinating, Polyneuropathy

Brief summary

Percentage of participants experiencing a response, Percentage of participants randomized to riliprubart with lasting response, Percentage of participants randomized to placebo who experience a response

Detailed description

Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) score, Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, Change from baseline in grip strength (kilopascals; dominant hand), Change from baseline in Medical Research Council Sum Score (MRC-SS), Percentage of participants refractory to immunoglobulins experiencing a response, Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A, Incidence and titer of anti-riliprubart antibodies (ADA), Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B, Incidence and titer of anti-riliprubart antibodies, Change from baseline in I-RODS score, Change from baseline in adjusted INCAT score, Change from baseline in grip strength (kilopascals; dominant hand), Change from baseline in MRC-SS, Change from baseline in EQ-5D-5L score, Change from baseline in RT-FSS, Percentage of participants randomized to riliprubart who experience a response at Week 48 without prior response in Part A (delayed response)

Interventions

DRUGriliprubart placebo
DRUGsolution for injection in prefilled pen (PFP)
DRUGsolution for injection in vial

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants experiencing a response, Percentage of participants randomized to riliprubart with lasting response, Percentage of participants randomized to placebo who experience a response

Secondary

MeasureTime frame
Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) score, Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, Change from baseline in grip strength (kilopascals; dominant hand), Change from baseline in Medical Research Council Sum Score (MRC-SS), Percentage of participants refractory to immunoglobulins experiencing a response, Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A, Incidence and titer of anti-riliprubart antibodies (ADA), Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B, Incidence and titer of anti-riliprubart antibodies, Change fro

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026