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Long-term extension study to evaluate the safety and efficacy of riliprubart (SAR445088) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517032-22-00
Acronym
LTS17261
Enrollment
155
Registered
2025-04-22
Start date
2025-06-10
Completion date
Unknown
Last updated
2025-12-05

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

Conditions

Immune system diseases.

Brief summary

Number of participants having any adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, electrocardiograms (ECGs), and vital signs during the study period.

Detailed description

Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)., Percentage of participants experiencing improvement from baseline., Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time., Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time., Change from baseline in grip strength (kilopascals; dominant hand) over time., Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time.

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of participants having any adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, electrocardiograms (ECGs), and vital signs during the study period.

Secondary

MeasureTime frame
Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)., Percentage of participants experiencing improvement from baseline., Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time., Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time., Change from baseline in grip strength (kilopascals; dominant hand) over time., Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time.

Countries

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

Outcome results

None listed

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