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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)
Sponsor: 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.
Official title: A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2024-08-21
Completion Date
2029-01-12
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
riliprubart
Pharmaceutical form: Solution Route of administration: IV solution
Placebo
Pharmaceutical form: Solution Route of administration: IV solution
riliprubart
Pharmaceutical form: Solution Route of administration: SC solution
Placebo
Pharmaceutical form: Solution Route of administration: SC solution
IVIg
Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
Placebo
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Locations (113)
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
Scottsdale, Arizona, United States
Keck School of Medicine of University of Southern California- Site Number : 8400002
Los Angeles, California, United States
University of California Irvine Medical Center- Site Number : 8400007
Orange, California, United States
Yale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States
AdventHealth Orlando- Site Number : 8400006
Orlando, Florida, United States
AdventHealth Site Number : 8400006
Orlando, Florida, United States
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States
University of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans, Louisiana, United States
Johns Hopkins Hospital- Site Number : 8400015
Baltimore, Maryland, United States
Massachusetts General Hospital- Site Number : 8400009
Boston, Massachusetts, United States
Henry Ford Hospital- Site Number : 8400025
Detroit, Michigan, United States
Michigan State University- Site Number : 8400038
East Lansing, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
St Louis, Missouri, United States
Dent Neurologic Institute - Amherst- Site Number : 8400039
Amherst, New York, United States
Hospital for Special Surgery- Site Number : 8400041
New York, New York, United States
Columbia University Irving Medical Center- Site Number : 8400003
New York, New York, United States
Raleigh Neurology Associates- Site Number : 8400043
Raleigh, North Carolina, United States
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland, Ohio, United States
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, United States
Austin Neuromuscular Center- Site Number : 8400040
Austin, Texas, United States
University of Vermont Medical Center- Site Number : 8400012
Burlington, Vermont, United States
University of Virginia- Site Number : 8400023
Charlottesville, Virginia, United States
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320003
Buenos Aires, Argentina
Investigational Site Number : 0560002
Ghent, Belgium
Investigational Site Number : 0560001
Leuven, Belgium
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
Brasília, Federal District, Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
Curitiba, Paraná, Brazil
InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, Brazil
Investigational Site Number : 1240003
London, Ontario, Canada
Investigational Site Number : 1240006
Montreal, Quebec, Canada
Investigational Site Number : 1240001
Québec, Quebec, Canada
Investigational Site Number : 1560013
Beijing, China
Investigational Site Number : 1560010
Beijing, China
Investigational Site Number : 1560005
Beijing, China
Investigational Site Number : 1560017
Beijing, China
Investigational Site Number : 1560009
Changsha, China
Investigational Site Number : 1560011
Chengdu, China
Investigational Site Number : 1560002
Fuzhou, China
Investigational Site Number : 1560012
Guangzhou, China
Investigational Site Number : 1560007
Guangzhou, China
Investigational Site Number : 1560014
Hangzhou, China
Investigational Site Number : 1560016
Jiazhuang, China
Investigational Site Number : 1560008
Jinan, China
Investigational Site Number : 1560015
Nanchang, China
Investigational Site Number : 1560001
Shanghai, China
Investigational Site Number : 1560003
Wuhan, China
Investigational Site Number : 1560006
Wuhan, China
Investigational Site Number : 1560004
Xi'an, China
Investigational Site Number : 2030004
Brno, Czechia
Investigational Site Number : 2030003
Hradec Králové, Czechia
Investigational Site Number : 2030005
Ostrava, Czechia
Investigational Site Number : 2030002
Pardubice, Czechia
Investigational Site Number : 2030001
Prague, Czechia
Investigational Site Number : 2080002
Aarhus, Denmark
Investigational Site Number : 2080001
Copenhagen, Denmark
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, France
Investigational Site Number : 2500002
Marseille, France
Investigational Site Number : 2500005
Nice, France
Investigational Site Number : 2500003
Paris, France
Investigational Site Number : 2760003
Berlin, Germany
Investigational Site Number : 2760006
Göttingen, Germany
Investigational Site Number : 2760005
Hanover, Germany
Investigational Site Number : 2760001
Münster, Germany
Investigational Site Number : 3480003
Budapest, Hungary
Investigational Site Number : 3480004
Győr, Hungary
Investigational Site Number : 3480001
Szeged, Hungary
Investigational Site Number : 3760001
Haifa, Israel
Investigational Site Number : 3800002
Bologna, Italy
Investigational Site Number : 3920007
Amagasaki, Hyōgo, Japan
Investigational Site Number : 3920015
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920012
Higashi-Matsuyama, Saitama, Japan
Investigational Site Number : 3920005
Kawagoe, Saitama, Japan
Investigational Site Number : 3920014
Yaizu, Shizuoka, Japan
Investigational Site Number : 3920008
Kodaira, Tokyo, Japan
Investigational Site Number : 3920010
Ōta-ku, Tokyo, Japan
Investigational Site Number : 3920001
Chiba, Japan
Investigational Site Number : 3920009
Saga, Japan
Investigational Site Number : 4840002
Chihuahua City, Mexico
Investigational Site Number : 4840001
Tlalnepantla, Mexico
Investigational Site Number : 5780001
Oslo, Norway
Investigational Site Number : 6200003
Braga, Portugal
Investigational Site Number : 6200005
Coimbra, Portugal
Investigational Site Number : 6200002
Lisbon, Portugal
Investigational Site Number : 6200001
Lisbon, Portugal
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Sabadell, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240008
Majadahonda, Madrid, Spain
Investigational Site Number : 7240002
Pamplona, Navarre, Spain
Investigational Site Number : 7240003
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240007
Málaga, Spain
Investigational Site Number : 7240010
Santa Cruz de Tenerife, Spain
Investigational Site Number : 7240004
Valencia, Spain
Investigational Site Number : 7520001
Stockholm, Sweden
Investigational Site Number : 7560001
Basel, Switzerland
Investigational Site Number : 7560003
Bern, Switzerland
Investigational Site Number : 1580003
Kaohsiung City, Taiwan
Investigational Site Number : 1580001
Taipei, Taiwan
Investigational Site Number : 1580002
Taipei, Taiwan
Investigational Site Number : 7920004
Bursa, Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920003
Konya, Turkey (Türkiye)
Investigational Site Number : 8260007
London, England, United Kingdom
Investigational Site Number : 8260003
Inverness, Highland, United Kingdom
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom