A Phase 3, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Riliprubart in Participants With Refractory Chronic Inflammatory Demyelinating Polyneuropathy
Sanofi
Summary
The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 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 two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee. * Participant must be refractory to either immunoglobulin therapy or corticoster…
Interventions
- DrugRiliprubart
Pharmaceutical form: Solution Route of administration: IV Infusion
- DrugPlacebo
Pharmaceutical form: Solution Route of administration: IV Infusion
- DrugRiliprubart
Pharmaceutical form: Solution Route of administration: SC Injection
- DrugPlacebo
Pharmaceutical form: Solution Route of administration: SC Injection
Locations (125)
- Alabama Neurology Associates- Site Number : 8400019Homewood, Alabama
- USC Norris Comprehensive Cancer Center- Site Number : 8400002Los Angeles, California
- University of California Irvine - Manchester Pavilion- Site Number : 8400007Orange, California
- Yale University School of Medicine- Site Number : 8400018New Haven, Connecticut
- NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024Glenview, Illinois
- University of Kansas Medical Center (KUMC)- Site Number : 8400010Westwood, Kansas