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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)
This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.
This is a single-arm study. All participants transitioning to Study LTS17261 will receive riliprubart weekly for up to 3 years, or until commercialization of riliprubart for the treatment of CIDP or termination of the riliprubart clinical development program for the treatment of CIDP, or the local availability of other options for long-term treatment with riliprubart, whichever comes first. The total number of study visits will be 12.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States
University of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, United States
Investigational Site Number : 0320003
Buenos Aires, Argentina
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004
Ribeirão Preto, São Paulo, Brazil
Investigational Site Number : 1240001
Gatineau, Quebec, Canada
Investigational Site Number : 1240002
Québec, Quebec, Canada
Investigational Site Number : 1520003
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560013
Beijing, China
Investigational Site Number : 1560005
Beijing, China
Start Date
April 1, 2025
Primary Completion Date
October 3, 2029
Completion Date
October 3, 2029
Last Updated
March 5, 2026
300
ESTIMATED participants
Riliprubart Prefilled Pen (PFP)
DRUG
Lead Sponsor
Sanofi
NCT06968975
NCT01847937
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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