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NCT06290141PHASE3Recruiting

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)

Sanofi

Start Date

8/21/2024

Completion Date

1/12/2029

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 Criteria

Age Range: 18 years to No maximum

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 must be on a stable maintenance dosage of IVIg. * Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT). * Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines. * Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline. * 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 * Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive. * Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy. * Sensory CIDP, distal CIDP and focal CIDP variants. * Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments. * Poorly controlled diabetes * Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections). * Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody. * Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening). * Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment. * Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt. * Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse. * Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk. * Recent treatment with plasma exchange * Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive/ chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine). * Prior treatment with riliprubart. * Recent use of any specific complement system inhibitor (eg, eculizumab). * Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation. * Prior treatment with B-cell depleting agents such as rituximab within 6 months. * Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening). * Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening. * Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial. * Positive result of any of the following tests: * hepatitis B surface antigen (HbsAg). * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \[anti-HBs Ab\] are also positive, indicating natural immunity). * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained. * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies. * Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation. * Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized. * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. * Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol. * Recent treatment with efgartigimod. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions

DRUG

riliprubart

DRUG

Placebo

DRUG

riliprubart

DRUG

Placebo

DRUG

IVIg

DRUG

Placebo

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Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Locations

Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama 35209

United States

Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014

Scottsdale, Arizona 85251

United States

Keck School of Medicine of University of Southern California- Site Number : 8400002

Los Angeles, California 90033

United States

University of California Irvine Medical Center- Site Number : 8400007

Orange, California 92868

United States

IMMUNOe International Research Centers - Centennial- Site Number : 8400049

Centennial, Colorado 80112

United States

Yale University School of Medicine- Site Number : 8400018

New Haven, Connecticut 06510

United States

Nova Clinical Research - Bradenton- Site Number : 8400044

Bradenton, Florida 34209

United States

Design Neuroscience Center- Site Number : 8400053

Miami Lakes, Florida 33016

United States

AdventHealth Orlando- Site Number : 8400006

Orlando, Florida 32803

United States

AdventHealth Site Number : 8400006

Orlando, Florida 32804-5558

United States

NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024

Glenview, Illinois 60026

United States

University of Kansas Medical Center- Site Number : 8400010

Kansas City, Kansas 66160

United States

Ochsner Medical Center - Jefferson Highway- Site Number : 8400030

New Orleans, Louisiana 70121

United States

Johns Hopkins Hospital- Site Number : 8400015

Baltimore, Maryland 21287

United States

Massachusetts General Hospital- Site Number : 8400009

Boston, Massachusetts 02114

United States

Henry Ford Hospital- Site Number : 8400025

Detroit, Michigan 48202

United States

Michigan State University- Site Number : 8400038

East Lansing, Michigan 48824

United States

Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037

St Louis, Missouri 63110

United States

Profound Research- Site Number : 8400052

Las Vegas, Nevada 89106

United States

Dent Neurologic Institute - Amherst- Site Number : 8400039

Amherst, New York 14226

United States

Hospital for Special Surgery - Site Number : 8400041

New York, New York 10021

United States

Columbia University Irving Medical Center- Site Number : 8400003

New York, New York 10032

United States

Raleigh Neurology Associates- Site Number : 8400043

Raleigh, North Carolina 27607

United States

University of Cincinnati Medical Center- Site Number : 8400020

Cincinnati, Ohio 45219

United States

University Hospitals Cleveland Medical Center- Site Number : 8400033

Cleveland, Ohio 44106

United States

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

Hershey, Pennsylvania 17033

United States

Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022

Philadelphia, Pennsylvania 19104

United States

Austin Neuromuscular Center- Site Number : 8400040

Austin, Texas 78756

United States

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

Houston, Texas 77054

United States

University of Vermont Medical Center- Site Number : 8400012

Burlington, Vermont 05401

United States

University of Virginia- Site Number : 8400023

Charlottesville, Virginia 22908

United States

Investigational Site Number : 0320001

Buenos Aires, 1015

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1181

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1221

Argentina

Investigational Site Number : 0560002

Ghent, 9000

Belgium

Investigational Site Number : 0560001

Leuven, 3000

Belgium

L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006

Brasília, Federal District 70200-730

Brazil

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

Belo Horizonte, Minas Gerais 30150-320

Brazil

Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007

Curitiba, Paraná 81210-310

Brazil

InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

PSEG Centro de Pesquisa Clínica- Site Number : 0760009

São Paulo, 04038-002

Brazil

Investigational Site Number : 1240003

London, Ontario N6A 5A5

Canada

Investigational Site Number : 1240006

Montreal, Quebec H3a 2b4

Canada

Investigational Site Number : 1240001

Québec, Quebec G1E 7G9

Canada

Investigational Site Number : 1560013

Beijing, 100034

China

Investigational Site Number : 1560010

Beijing, 100050

China

Investigational Site Number : 1560005

Beijing, 100053

China

Investigational Site Number : 1560017

Beijing, 100730

China

Investigational Site Number : 1560009

Changsha, 410008

China

Investigational Site Number : 1560011

Chengdu, 610072

China

Investigational Site Number : 1560002

Fuzhou, 350001

China

Investigational Site Number : 1560012

Guangzhou, 510000

China

Investigational Site Number : 1560007

Guangzhou, 510080

China

Investigational Site Number : 1560014

Hangzhou, 310003

China

Investigational Site Number : 1560016

Jiazhuang, 050000

China

Investigational Site Number : 1560008

Jinan, 250014

China

Investigational Site Number : 1560015

Nanchang, 330006

China

Investigational Site Number : 1560001

Shanghai, 200040

China

Investigational Site Number : 1560003

Wuhan, 430030

China

Investigational Site Number : 1560006

Wuhan, 430060

China

Investigational Site Number : 1560004

Xi'an, 710038

China

Investigational Site Number : 2030004

Brno, 625 00

Czechia

Investigational Site Number : 2030003

Hradec Králové, 500 05

Czechia

Investigational Site Number : 2030005

Ostrava, 708 52

Czechia

Investigational Site Number : 2030002

Pardubice, 532 03

Czechia

Investigational Site Number : 2030001

Prague, 128 08

Czechia

Investigational Site Number : 2080002

Aarhus, 8200

Denmark

Investigational Site Number : 2080001

Copenhagen, 2100

Denmark

Investigational Site Number : 2500001

Le Kremlin-Bicêtre, 94270

France

Investigational Site Number : 2500006

Lille, 59037

France

Investigational Site Number : 2500002

Marseille, 13885

France

Investigational Site Number : 2500005

Nice, 06001

France

Investigational Site Number : 2500003

Paris, 75013

France

Investigational Site Number : 2760003

Berlin, 10117

Germany

Investigational Site Number : 2760008

Bochum, 44791

Germany

Investigational Site Number : 2760007

Essen, 45147

Germany

Investigational Site Number : 2760006

Göttingen, 37075

Germany

Investigational Site Number : 2760005

Hanover, 30625

Germany

Investigational Site Number : 2760009

Homburg, 66421

Germany

Investigational Site Number : 2760001

Münster, 48149

Germany

Investigational Site Number : 3480003

Budapest, 1085

Hungary

Investigational Site Number : 3480005

Budapest, 1125

Hungary

Investigational Site Number : 3480004

Győr, 9024

Hungary

Investigational Site Number : 3480001

Szeged, 6720

Hungary

Investigational Site Number : 3760001

Haifa, 3109601

Israel

Investigational Site Number : 3800004

Milan, Milano 20132

Italy

Investigational Site Number : 3800003

Milan, Milano 20133

Italy

Investigational Site Number : 3800005

Rozzano, Milano 20089

Italy

Investigational Site Number : 3800001

Padua, Padova 35128

Italy

Investigational Site Number : 3800002

Bologna, 40139

Italy

Investigational Site Number : 3920007

Amagasaki, Hyōgo 660-8511

Japan

Investigational Site Number : 3920015

Yokohama, Kanagawa 222-0036

Japan

Investigational Site Number : 3920012

Higashi-Matsuyama, Saitama 355-0005

Japan

Investigational Site Number : 3920005

Kawagoe, Saitama 350-8550

Japan

Investigational Site Number : 3920014

Yaizu, Shizuoka 425-8505

Japan

Investigational Site Number : 3920008

Kodaira, Tokyo 187-8551

Japan

Investigational Site Number : 3920010

Ōta-ku, Tokyo 143-8541

Japan

Investigational Site Number : 3920001

Chiba, 260-8677

Japan

Investigational Site Number : 3920009

Saga, 849-0937

Japan

Investigational Site Number : 4840002

Chihuahua City, 31000

Mexico

Investigational Site Number : 4840001

Tlalnepantla, 54055

Mexico

Investigational Site Number : 5780001

Oslo, 0450

Norway

Investigational Site Number : 6200003

Braga, 4710-243

Portugal

Investigational Site Number : 6200005

Coimbra, 3000-075

Portugal

Investigational Site Number : 6200002

Lisbon, 1150-199

Portugal

Investigational Site Number : 6200001

Lisbon, 1349-019

Portugal

Investigational Site Number : 7240012

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Investigational Site Number : 7240009

Barcelona, Barcelona [Barcelona] 08035

Spain

Investigational Site Number : 7240006

Sabadell, Barcelona [Barcelona] 08208

Spain

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña] 08041

Spain

Investigational Site Number : 7240008

Majadahonda, Madrid 28222

Spain

Investigational Site Number : 7240002

Pamplona, Navarre 31008

Spain

Investigational Site Number : 7240003

Oviedo, Principality of Asturias 33011

Spain

Investigational Site Number : 7240007

Málaga, 29010

Spain

Investigational Site Number : 7240010

Santa Cruz de Tenerife, 38010

Spain

Investigational Site Number : 7240004

Valencia, 46026

Spain

Investigational Site Number : 7520001

Stockholm, 113 65

Sweden

Investigational Site Number : 7560001

Basel, 4056

Switzerland

Investigational Site Number : 7560003

Bern, 3010

Switzerland

Investigational Site Number : 1580003

Kaohsiung City, 833

Taiwan

Investigational Site Number : 1580001

Taipei, 100

Taiwan

Investigational Site Number : 1580002

Taipei, 112

Taiwan

Investigational Site Number : 7920004

Bursa, 16059

Turkey (Türkiye)

Investigational Site Number : 7920001

Istanbul, 34093

Turkey (Türkiye)

Investigational Site Number : 7920002

Istanbul, 34785

Turkey (Türkiye)

Investigational Site Number : 7920003

Konya, 42075

Turkey (Türkiye)

Investigational Site Number : 8260007

London, England E1 1BB

United Kingdom

Investigational Site Number : 8260003

Inverness, Highland IV2 3UJ

United Kingdom

Investigational Site Number : 8260001

Oxford, Oxfordshire OX3 9DU

United Kingdom