NCT06859099

Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP

Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Polyneuropathy, Inflammatory Demyelinating, Chronic

Interventions

Type	Name	Description
DRUG	Riliprubart Prefilled Pen (PFP)	Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Timeline

• Start date: 2025-04-01
• Primary completion: 2029-10-03
• Completion: 2029-10-03
• First posted: 2025-03-05
• Last updated: 2026-04-16

Locations

44 sites across 19 countries: United States, Argentina, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Portugal, Serbia, South Korea, Spain, Sweden

Regulatory

• FDA-regulated drug study