Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trials

Find Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trials Near You

A Phase 3, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Riliprubart in Participants With Refractory Chronic Inflammatory Demyelinating Polyneuropathy

Status: Recruiting
Location: See all (121) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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 corticosteroid therapy, as defined below.

‣ Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening

⁃ Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening

• Participant has an INCAT score of 2 to 9

• Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months

• Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone or equivalent)

• Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening

• Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention

• Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant

• A body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive

Locations
United States
Alabama
Alabama Neurology Associates- Site Number : 8400019
RECRUITING
Homewood
California
USC Norris Comprehensive Cancer Center- Site Number : 8400002
RECRUITING
Los Angeles
University of California Irvine - Manchester Pavilion- Site Number : 8400007
RECRUITING
Orange
Connecticut
Yale University School of Medicine- Site Number : 8400018
RECRUITING
New Haven
Illinois
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
RECRUITING
Glenview
Kansas
University of Kansas Medical Center (KUMC)- Site Number : 8400010
RECRUITING
Westwood
Louisiana
NeuroMedical Clinic of Central Louisiana- Site Number : 8400031
RECRUITING
Alexandria
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital- Site Number : 8400009
RECRUITING
Boston
Maryland
Johns Hopkins Hospital- Site Number : 8400015
RECRUITING
Baltimore
Michigan
Henry Ford Hospital- Site Number : 8400025
RECRUITING
Detroit
Michigan State University- Site Number : 8400038
RECRUITING
East Lansing
Missouri
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
RECRUITING
St Louis
North Carolina
Raleigh Neurology Associates- Site Number : 8400043
RECRUITING
Raleigh
New York
Columbia University Irving Medical Center- Site Number : 8400003
RECRUITING
New York
Hospital for Special Surgery- Site Number : 8400041
RECRUITING
New York
Ohio
University of Cincinnati Medical Center- Site Number : 8400020
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center- Site Number : 8400033
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Cleveland
Pennsylvania
Penn State Health Milton South Hershey Medical Center- Site Number : 8400042
RECRUITING
Hershey
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
RECRUITING
Philadelphia
Texas
Austin Neuromuscular Center- Site Number : 8400040
RECRUITING
Austin
Virginia
University of Virginia- Site Number : 8400023
RECRUITING
Charlottesville
Vermont
University of Vermont Medical Center- Site Number : 8400012
RECRUITING
Burlington
Other Locations
Argentina
Investigational Site Number : 0320001
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Buenos Aires
Investigational Site Number : 0320002
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Buenos Aires
Investigational Site Number : 0320003
RECRUITING
Buenos Aires
Belgium
Investigational Site Number : 0560001
RECRUITING
Leuven
Brazil
Hospital Moinhos de Vento- Site Number : 0760003
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760007
RECRUITING
Ribeirão Preto
Hospital Sao Rafael- Site Number : 0760011
RECRUITING
Salvador
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
RECRUITING
São Paulo
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760012
RECRUITING
Vitória
Bulgaria
Investigational Site Number : 1000002
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Blagoevgrad
Investigational Site Number : 1000001
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Pleven
Canada
Investigational Site Number : 1240001
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Québec
Chile
Investigational Site Number : 1520003
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Lo Barnechea
Investigational Site Number : 1520001
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Santiago
Investigational Site Number : 1520002
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Santiago
China
Investigational Site Number : 1560005
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Beijing
Investigational Site Number : 1560010
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Beijing
Investigational Site Number : 1560013
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Beijing
Investigational Site Number : 1560016
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Beijing
Investigational Site Number : 1560009
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Changsha
Investigational Site Number : 1560011
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Chengdu
Investigational Site Number : 1560002
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Fuzhou
Investigational Site Number : 1560007
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Guangzhou
Investigational Site Number : 1560012
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Guangzhou
Investigational Site Number : 1560014
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Hangzhou
Investigational Site Number : 1560008
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Jinan
Investigational Site Number : 1560015
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Nanchang
Investigational Site Number : 1560001
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Shanghai
Investigational Site Number : 1560003
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Wuhan
Investigational Site Number : 1560006
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Wuhan
Investigational Site Number : 1560004
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Xi'an
Denmark
Investigational Site Number : 2080002
RECRUITING
Aarhus
Investigational Site Number : 2080001
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Copenhagen
France
Investigational Site Number : 2500001
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Le Kremlin-bicêtre
Investigational Site Number : 2500003
RECRUITING
Lille
Investigational Site Number : 2500002
RECRUITING
Marseille
Investigational Site Number : 2500005
RECRUITING
Montpellier
Investigational Site Number : 2500004
RECRUITING
Paris
Germany
Investigational Site Number : 2760001
RECRUITING
Bad Homburg
Investigational Site Number : 2760004
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Berlin
Investigational Site Number : 2760007
RECRUITING
Bochum
Investigational Site Number : 2760003
RECRUITING
Giessen
Investigational Site Number : 2760006
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Tübingen
Greece
Investigational Site Number : 3000002
RECRUITING
Athens
Investigational Site Number : 3000003
RECRUITING
Larissa
Investigational Site Number : 3000001
RECRUITING
Thessaloniki
Italy
Investigational Site Number : 3800007
RECRUITING
Messina
Investigational Site Number : 3800001
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Milan
Investigational Site Number : 3800003
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Palermo
Investigational Site Number : 3800005
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Pavia
Investigational Site Number : 3800004
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Pisa
Investigational Site Number : 3800002
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Rome
Investigational Site Number : 3800006
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Rome
Investigational Site Number : 3800008
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Rome
Investigational Site Number : 3800009
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Rozzano
Japan
Investigational Site Number : 3920011
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Bunkyo
Investigational Site Number : 3920001
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Chiba
Investigational Site Number : 3920003
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Fukuoka
Investigational Site Number : 3920005
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Kawagoe
Investigational Site Number : 3920008
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Kodaira
Investigational Site Number : 3920009
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Saga
Investigational Site Number : 3920006
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Sayama
Investigational Site Number : 3920013
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Tokyo
Investigational Site Number : 3920014
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Yaizu
Mexico
Investigational Site Number : 4840005
RECRUITING
Culiacán
Investigational Site Number : 4840003
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Guadalajara
Investigational Site Number : 4840002
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Veracruz
Netherlands
Investigational Site Number : 5280001
RECRUITING
Amsterdam
Investigational Site Number : 5280002
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Rotterdam
Poland
Investigational Site Number : 6160006
RECRUITING
Krakow
Investigational Site Number : 6160002
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Lublin
Investigational Site Number : 6160003
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Rzeszów
Portugal
Investigational Site Number : 6200005
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Coimbra
Investigational Site Number : 6200001
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Lisbon
Investigational Site Number : 6200004
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Lisbon
Investigational Site Number : 6200003
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Matosinhos Municipality
Republic of Korea
Investigational Site Number : 4100001
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Seoul
Investigational Site Number : 4100002
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Seoul
Investigational Site Number : 4100003
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Seoul
Spain
Investigational Site Number : 7240001
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Barcelona
Investigational Site Number : 7240008
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Barcelona
Investigational Site Number : 7240007
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Bilbao
Investigational Site Number : 7240006
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Majadahonda
Investigational Site Number : 7240005
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Oviedo
Investigational Site Number : 7240003
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Pamplona
Investigational Site Number : 7240009
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Sabadell
Investigational Site Number : 7240010
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Santa Cruz De Tenerife
Investigational Site Number : 7240012
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Santiago De Compostela
Investigational Site Number : 7240002
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Valencia
Sweden
Investigational Site Number : 7520001
RECRUITING
Stockholm
Taiwan
Investigational Site Number : 1580003
RECRUITING
Kaohsiung City
Investigational Site Number : 1580001
RECRUITING
Taipei
Investigational Site Number : 1580002
RECRUITING
Taipei
Turkey
Investigational Site Number : 7920006
RECRUITING
Ankara
Investigational Site Number : 7920002
RECRUITING
Bursa
Investigational Site Number : 7920001
RECRUITING
Istanbul
Investigational Site Number : 7920004
RECRUITING
Istanbul
Investigational Site Number : 7920003
RECRUITING
Konya
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-07-12
Estimated Completion Date: 2028-11-20
Participants
Target number of participants: 140
Treatments
Experimental: Riliprubart Arm
Riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Placebo_comparator: Placebo Arm
Placebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov