A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy
Sanofi
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021). * Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee. * Participants must have responded to IVIg in the past 5 years. * Participant…
Interventions
- Drugriliprubart
Pharmaceutical form: Solution Route of administration: IV solution
- DrugPlacebo
Pharmaceutical form: Solution Route of administration: IV solution
- Drugriliprubart
Pharmaceutical form: Solution Route of administration: SC solution
- DrugPlacebo
Pharmaceutical form: Solution Route of administration: SC solution
- DrugIVIg
Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
- DrugPlacebo
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Locations (118)
- Alabama Neurology Associates- Site Number : 8400019Homewood, Alabama
- Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014Scottsdale, Arizona
- Keck School of Medicine of University of Southern California- Site Number : 8400002Los Angeles, California
- University of California Irvine Medical Center- Site Number : 8400007Orange, California
- Yale University School of Medicine- Site Number : 8400018New Haven, Connecticut
- Nova Clinical Research - Bradenton- Site Number : 8400044Bradenton, Florida