RecruitingPhase 3NCT06290141

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

Sponsor

Sanofi

Enrollment

160 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IVIg, a drug called Placebo, and others for people with chronic inflammatory demyelinating polyneuropathy. The study is currently recruiting participants at 129 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(135)

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

IMMUNOe International Research Centers - Centennial- Site Number : 8400049

Centennial, Colorado, United States

Yale University School of Medicine- Site Number : 8400018

New Haven, Connecticut, United States

Nova Clinical Research - Bradenton- Site Number : 8400044

Bradenton, Florida, United States

Design Neuroscience Center- Site Number : 8400053

Miami Lakes, Florida, 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

Profound Research- Site Number : 8400052

Las Vegas, Nevada, 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

Lenox Hill Hospital- Site Number : 8400051

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 State Health Milton South Hershey Medical Center- Site Number : 8400042

Hershey, Pennsylvania, 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

Gadolin Research - Beaumont- Site Number : 8400047

Beaumont, Texas, United States

UTHealth - The University of Texas Health Sciences Center at Houston- Site Number : 8400050

Houston, 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

Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760016

Belo Horizonte, Minas Gerais, 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 : 2500006

Lille, 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 : 2760008

Bochum, Germany

Investigational Site Number : 2760007

Essen, Germany

Investigational Site Number : 2760006

Göttingen, Germany

Investigational Site Number : 2760005

Hanover, Germany

Investigational Site Number : 2760009

Homburg, Germany

Investigational Site Number : 2760001

Münster, Germany

Investigational Site Number : 2760011

Schwäbisch Hall, Germany

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000002

Thessaloniki, Greece

Investigational Site Number : 3480003

Budapest, Hungary

Investigational Site Number : 3480005

Budapest, Hungary

Investigational Site Number : 3480004

Győr, Hungary

Investigational Site Number : 3480001

Szeged, Hungary

Investigational Site Number : 3760001

Haifa, Israel

Investigational Site Number : 3800004

Milan, Milano, Italy

Investigational Site Number : 3800003

Milan, Milano, Italy

Investigational Site Number : 3800005

Rozzano, Milano, Italy

Investigational Site Number : 3800001

Padua, Padova, Italy

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 : 6200006

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

View Full Details on ClinicalTrials.gov

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NCT06290141

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