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NCT06290128PHASE3Recruiting

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work

Sanofi

Start Date

7/12/2024

Completion Date

11/20/2028

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 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 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 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 Immunoglobulin M (IgM) monoclonal gammopathy, POEMS syndrome, and 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 and 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 other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact 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 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 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 * Participant has recently received immunoglobulins (IVIg or SCIg) * Recent treatment with plasma exchange * Prior treatment with riliprubart * Prior treatment with (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine * 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 * Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer * Treatment within 6 months prior to dosing with immunosuppressive/ chemotherapeutic medications, such as cyclophosphamide, methotrexate, tacrolimus, interferon, or tumor necrosis factor (TNF)-α inhibitors. Certain immunosuppressants commonly used in CIDP (azathioprine, cyclosporine, or mycophenolate mofetil) are allowed, as indicated under inclusion criterion. * 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; eg, imprisoned or legally institutionalized * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potential risk for noncompliance to study procedures * Participants are employees at the clinical study site or other individuals directly involved in the conduct of the study, or immediate family member of such individuals * Any country related specific regulation that would prevent the participant from entering the study * Recent treatment with efgartigimod The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions

DRUG

Riliprubart

DRUG

Placebo

DRUG

Riliprubart

DRUG

Placebo

Interested in This Trial?

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Conditions

Chronic Inflammatory Demyelinating PolyradiculoneuropathyPolyneuropathy, Inflammatory Demyelinating, Chronic

Locations

Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama 35209

United States

USC Norris Comprehensive Cancer Center- Site Number : 8400002

Los Angeles, California 90033

United States

University of California Irvine - Manchester Pavilion- 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

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

NeuroMedical Clinic of Central Louisiana- Site Number : 8400031

Alexandria, Louisiana 71301

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

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 : 0560001

Leuven, 3000

Belgium

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760012

Vitória, Espírito Santo 29055-450

Brazil

Hospital Sao Rafael- Site Number : 0760011

Salvador, Estado de Bahia 41253-190

Brazil

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

Belo Horizonte, Minas Gerais 30150-320

Brazil

Hospital Moinhos de Vento- Site Number : 0760003

Porto Alegre, Rio Grande do Sul 90035-902

Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760007

Ribeirão Preto, São Paulo 14049-900

Brazil

PSEG Centro de Pesquisa Clínica- Site Number : 0760009

São Paulo, 04038-002

Brazil

Investigational Site Number : 1000002

Blagoevgrad, 2700

Bulgaria

Investigational Site Number : 1000001

Pleven, 5800

Bulgaria

Investigational Site Number : 1240001

Québec, Quebec G1E 7G9

Canada

Investigational Site Number : 1520003

Lo Barnechea, Reg Metropolitana de Santiago 7691236

Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago 8207257

Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago 8380456

Chile

Investigational Site Number : 1560013

Beijing, 100034

China

Investigational Site Number : 1560010

Beijing, 100050

China

Investigational Site Number : 1560005

Beijing, 100053

China

Investigational Site Number : 1560016

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 : 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 : 2030002

Pardubice, 532 03

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 : 2500003

Lille, 59037

France

Investigational Site Number : 2500002

Marseille, 13885

France

Investigational Site Number : 2500005

Montpellier, 34295

France

Investigational Site Number : 2500004

Paris, 75013

France

Investigational Site Number : 2760001

Bad Homburg, 61348

Germany

Investigational Site Number : 2760004

Berlin, 12163

Germany

Investigational Site Number : 2760007

Bochum, 44791

Germany

Investigational Site Number : 2760005

Essen, 45147

Germany

Investigational Site Number : 2760003

Giessen, 35392

Germany

Investigational Site Number : 2760006

Tübingen, 72076

Germany

Investigational Site Number : 3000002

Athens, 124 62

Greece

Investigational Site Number : 3000003

Larissa, 411 10

Greece

Investigational Site Number : 3000001

Thessaloniki, 546 36

Greece

Investigational Site Number : 3800001

Milan, Milano 20132

Italy

Investigational Site Number : 3800009

Rozzano, Milano 20089

Italy

Investigational Site Number : 3800006

Rome, Roma 00133

Italy

Investigational Site Number : 3800008

Rome, Roma 00189

Italy

Investigational Site Number : 3800007

Messina, 98125

Italy

Investigational Site Number : 3800003

Palermo, 90127

Italy

Investigational Site Number : 3800005

Pavia, 27100

Italy

Investigational Site Number : 3800004

Pisa, 56126

Italy

Investigational Site Number : 3920006

Sayama, Osaka 589-8511

Japan

Investigational Site Number : 3920005

Kawagoe, Saitama 350-8550

Japan

Investigational Site Number : 3920014

Yaizu, Shizuoka 425-8505

Japan

Investigational Site Number : 3920011

Bunkyo-Ku, Tokyo 113-8510

Japan

Investigational Site Number : 3920008

Kodaira, Tokyo 187-8551

Japan

Investigational Site Number : 3920001

Chiba, 260-8677

Japan

Investigational Site Number : 3920003

Fukuoka, 812-8582

Japan

Investigational Site Number : 3920009

Saga, 849-0937

Japan

Investigational Site Number : 3920013

Tokyo, 173-8605

Japan

Investigational Site Number : 4840003

Guadalajara, Jalisco 44670

Mexico

Investigational Site Number : 4840005

Culiacán, Sinaloa 80020

Mexico

Investigational Site Number : 4840002

Veracruz, 91900

Mexico

Investigational Site Number : 5280001

Amsterdam, 1105 AZ

Netherlands

Investigational Site Number : 5280002

Rotterdam, 3015 CE

Netherlands

Investigational Site Number : 6160006

Krakow, Lesser Poland Voivodeship 31-501

Poland

Investigational Site Number : 6160002

Lublin, Lublin Voivodeship 20-016

Poland

Investigational Site Number : 6160003

Rzeszów, Podkarpackie Voivodeship 35-055

Poland

Investigational Site Number : 6200005

Coimbra, 3000-075

Portugal

Investigational Site Number : 6200004

Lisbon, 1150-199

Portugal

Investigational Site Number : 6200001

Lisbon, 1349-019

Portugal

Investigational Site Number : 6200003

Matosinhos Municipality, 4464-513

Portugal

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi 02841

South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi 05505

South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi 06351

South Korea

Investigational Site Number : 7240012

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Investigational Site Number : 7240008

Barcelona, Barcelona [Barcelona] 08035

Spain

Investigational Site Number : 7240007

Bilbao, Basque Country 48013

Spain

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña] 08041

Spain

Investigational Site Number : 7240006

Majadahonda, Madrid 28222

Spain

Investigational Site Number : 7240003

Pamplona, Navarre 31008

Spain

Investigational Site Number : 7240005

Oviedo, Principality of Asturias 33011

Spain

Investigational Site Number : 7240009

Sabadell, 08208

Spain

Investigational Site Number : 7240010

Santa Cruz de Tenerife, 38010

Spain

Investigational Site Number : 7240002

Valencia, 46026

Spain

Investigational Site Number : 7520001

Stockholm, 113 65

Sweden

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 : 7920006

Ankara, 06170

Turkey (Türkiye)

Investigational Site Number : 7920007

Ankara, 06620

Turkey (Türkiye)

Investigational Site Number : 7920002

Bursa, 16059

Turkey (Türkiye)

Investigational Site Number : 7920001

Istanbul, 34093

Turkey (Türkiye)

Investigational Site Number : 7920004

Istanbul, 34785

Turkey (Türkiye)

Investigational Site Number : 7920003

Konya, 42075

Turkey (Türkiye)