NCT06290141

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	riliprubart	Pharmaceutical form: Solution Route of administration: IV solution
DRUG	Placebo	Pharmaceutical form: Solution Route of administration: IV solution
DRUG	riliprubart	Pharmaceutical form: Solution Route of administration: SC solution
DRUG	Placebo	Pharmaceutical form: Solution Route of administration: SC solution
DRUG	IVIg	Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
DRUG	Placebo	Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution

Timeline

• Start date: 2024-08-21
• Primary completion: 2027-07-09
• Completion: 2029-01-12
• First posted: 2024-03-04
• Last updated: 2026-04-16

Locations

115 sites across 23 countries: United States, Argentina, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Norway, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study