drugset / Trial / NCT06859099

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

NCT06859099

Phase 3 Enrolling by invitation 300 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-04-01
Primary completion
2029-10-03
Completion
2029-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Riliprubart Monoclonal antibody Subcutaneous