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

NCT06290128 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC17236U1111-1295-57552023-506503-26
• Study Type: interventional
• Target: 140
• Locations: 24 countries
• Sites: 125

Brief 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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Polyneuropathy, Inflammatory Demyelinating, Chronic

Keywords

Autoimmune Diseases, Neurologic; Autoimmune Disorders, Nervous System; Peripheral Nerves Disease; Nervous System Diseases; Neurologic Disorders; Neurological Disorders; Complement Inhibitor; Complement Inhibitors

Outcome Measures

Primary Outcomes (3)

• Percentage of participants experiencing a response

  A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24.

  Baseline to week 24

• Percentage of participants randomized to riliprubart with lasting response

  Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score at week 48 versus baseline.

  Baseline to week 48

• Percentage of participants randomized to placebo who experience a response

  A response is defined as a decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus week 24.

  Week 24 to week 48

Secondary Outcomes (18)

• Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score

  Baseline to week 24

• Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score

  Baseline to week 24

• Change from baseline in grip strength (kilopascals; dominant hand)

  Baseline to week 24

• Change from baseline in Medical Research Council Sum Score (MRC-SS)

  Baseline to week 24

• Percentage of participants refractory to immunoglobulins experiencing a response

  Baseline to week 24

Study Arms (2)

Riliprubart Arm

EXPERIMENTAL

Riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

Drug: Riliprubart; Drug: Placebo

Placebo Arm

PLACEBO COMPARATOR

Placebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

Drug: Riliprubart; Drug: Placebo

Interventions

Placebo DRUG

Pharmaceutical form: Solution Route of administration: IV Infusion

Placebo Arm; Riliprubart Arm

Riliprubart DRUG

Pharmaceutical form: Solution Route of administration: IV Infusion

Also known as: SAR445088

Placebo Arm; Riliprubart Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (125)

Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama, 35209, United States

RECRUITING

USC Norris Comprehensive Cancer Center- Site Number : 8400002

Los Angeles, California, 90033, United States

RECRUITING

University of California Irvine - Manchester Pavilion- Site Number : 8400007

Orange, California, 92868, United States

RECRUITING

Yale University School of Medicine- Site Number : 8400018

New Haven, Connecticut, 06510, United States

RECRUITING

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

Glenview, Illinois, 60026, United States

RECRUITING

University of Kansas Medical Center (KUMC)- Site Number : 8400010

Westwood, Kansas, 66205-2003, United States

RECRUITING

NeuroMedical Clinic of Central Louisiana- Site Number : 8400031

Alexandria, Louisiana, 71301, United States

RECRUITING

Ochsner Medical Center - Jefferson Highway- Site Number : 8400030

New Orleans, Louisiana, 70121, United States

RECRUITING

Johns Hopkins Hospital- Site Number : 8400015

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital- Site Number : 8400009

Boston, Massachusetts, 02114, United States

RECRUITING

Henry Ford Hospital- Site Number : 8400025

Detroit, Michigan, 48202, United States

RECRUITING

Michigan State University- Site Number : 8400038

East Lansing, Michigan, 48824, United States

RECRUITING

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

St Louis, Missouri, 63110, United States

RECRUITING

Profound Research- Site Number : 8400052

Las Vegas, Nevada, 89106, United States

RECRUITING

Hospital for Special Surgery- Site Number : 8400041

New York, New York, 10021, United States

RECRUITING

Columbia University Irving Medical Center- Site Number : 8400003

New York, New York, 10032, United States

RECRUITING

Raleigh Neurology Associates- Site Number : 8400043

Raleigh, North Carolina, 27607, United States

RECRUITING

University of Cincinnati Medical Center- Site Number : 8400020

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals Cleveland Medical Center- Site Number : 8400033

Cleveland, Ohio, 44106, United States

RECRUITING

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

Hershey, Pennsylvania, 17033, United States

RECRUITING

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

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Austin Neuromuscular Center- Site Number : 8400040

Austin, Texas, 78756, United States

RECRUITING

University of Vermont Medical Center- Site Number : 8400012

Burlington, Vermont, 05401, United States

RECRUITING

University of Virginia- Site Number : 8400023

Charlottesville, Virginia, 22908, United States

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1015, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1181, Argentina

RECRUITING

Investigational Site Number : 0320003

Buenos Aires, 1221, Argentina

RECRUITING

Investigational Site Number : 0560001

Leuven, 3000, Belgium

RECRUITING

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

Vitória, Espírito Santo, 29055-450, Brazil

RECRUITING

Hospital Sao Rafael- Site Number : 0760011

Salvador, Estado de Bahia, 41253-190, Brazil

RECRUITING

Hospital Moinhos de Vento- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, 90035-902, Brazil

RECRUITING

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

PSEG Centro de Pesquisa Clínica- Site Number : 0760009

São Paulo, 04038-002, Brazil

RECRUITING

Investigational Site Number : 1000002

Blagoevgrad, 2700, Bulgaria

RECRUITING

Investigational Site Number : 1000001

Pleven, 5800, Bulgaria

RECRUITING

Investigational Site Number : 1240001

Québec, Quebec, G1E 7G9, Canada

RECRUITING

Investigational Site Number : 1520003

Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile

RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8207257, Chile

RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8380456, Chile

RECRUITING

Investigational Site Number : 1560013

Beijing, 100034, China

RECRUITING

Investigational Site Number : 1560010

Beijing, 100050, China

RECRUITING

Investigational Site Number : 1560005

Beijing, 100053, China

RECRUITING

Investigational Site Number : 1560016

Beijing, 100730, China

RECRUITING

Investigational Site Number : 1560009

Changsha, 410008, China

RECRUITING

Investigational Site Number : 1560011

Chengdu, 610072, China

RECRUITING

Investigational Site Number : 1560002

Fuzhou, 350001, China

RECRUITING

Investigational Site Number : 1560012

Guangzhou, 510000, China

RECRUITING

Investigational Site Number : 1560007

Guangzhou, 510080, China

RECRUITING

Investigational Site Number : 1560014

Hangzhou, 310003, China

RECRUITING

Investigational Site Number : 1560008

Jinan, 250014, China

RECRUITING

Investigational Site Number : 1560015

Nanchang, 330006, China

RECRUITING

Investigational Site Number : 1560001

Shanghai, 200040, China

RECRUITING

Investigational Site Number : 1560003

Wuhan, 430030, China

RECRUITING

Investigational Site Number : 1560006

Wuhan, 430060, China

RECRUITING

Investigational Site Number : 1560004

Xi'an, 710038, China

RECRUITING

Investigational Site Number : 2030004

Brno, 625 00, Czechia

RECRUITING

Investigational Site Number : 2030003

Hradec Králové, 500 05, Czechia

RECRUITING

Investigational Site Number : 2030002

Pardubice, 532 03, Czechia

COMPLETED

Investigational Site Number : 2080002

Aarhus, 8200, Denmark

RECRUITING

Investigational Site Number : 2080001

Copenhagen, 2100, Denmark

RECRUITING

Investigational Site Number : 2500001

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Investigational Site Number : 2500003

Lille, 59037, France

RECRUITING

Investigational Site Number : 2500002

Marseille, 13885, France

RECRUITING

Investigational Site Number : 2500005

Montpellier, 34295, France

RECRUITING

Investigational Site Number : 2500004

Paris, 75013, France

RECRUITING

Investigational Site Number : 2760001

Bad Homburg, 61348, Germany

RECRUITING

Investigational Site Number : 2760004

Berlin, 12163, Germany

RECRUITING

Investigational Site Number : 2760007

Bochum, 44791, Germany

RECRUITING

Investigational Site Number : 2760003

Giessen, 35392, Germany

RECRUITING

Investigational Site Number : 2760006

Tübingen, 72076, Germany

RECRUITING

Investigational Site Number : 3000002

Athens, 124 62, Greece

RECRUITING

Investigational Site Number : 3000003

Larissa, 411 10, Greece

RECRUITING

Investigational Site Number : 3000001

Thessaloniki, 546 36, Greece

RECRUITING

Investigational Site Number : 3800001

Milan, Milano, 20132, Italy

RECRUITING

Investigational Site Number : 3800009

Rozzano, Milano, 20089, Italy

RECRUITING

Investigational Site Number : 3800006

Rome, Roma, 00133, Italy

RECRUITING

Investigational Site Number : 3800002

Rome, Roma, 00168, Italy

RECRUITING

Investigational Site Number : 3800008

Rome, Roma, 00189, Italy

RECRUITING

Investigational Site Number : 3800007

Messina, 98125, Italy

RECRUITING

Investigational Site Number : 3800003

Palermo, 90127, Italy

RECRUITING

Investigational Site Number : 3800005

Pavia, 27100, Italy

RECRUITING

Investigational Site Number : 3800004

Pisa, 56126, Italy

RECRUITING

Investigational Site Number : 3920006

Sayama, Osaka, 589-8511, Japan

RECRUITING

Investigational Site Number : 3920005

Kawagoe, Saitama, 350-8550, Japan

RECRUITING

Investigational Site Number : 3920014

Yaizu, Shizuoka, 425-8505, Japan

RECRUITING

Investigational Site Number : 3920011

Bunkyo, Tokyo, 113-8510, Japan

RECRUITING

Investigational Site Number : 3920008

Kodaira, Tokyo, 187-8551, Japan

RECRUITING

Investigational Site Number : 3920001

Chiba, 260-8677, Japan

RECRUITING

Investigational Site Number : 3920003

Fukuoka, 812-8582, Japan

RECRUITING

Investigational Site Number : 3920009

Saga, 849-0937, Japan

RECRUITING

Investigational Site Number : 3920013

Tokyo, 173-8605, Japan

RECRUITING

Investigational Site Number : 4840003

Guadalajara, Jalisco, 44670, Mexico

RECRUITING

Investigational Site Number : 4840005

Culiacán, Sinaloa, 80020, Mexico

RECRUITING

Investigational Site Number : 4840002

Veracruz, 91900, Mexico

RECRUITING

Investigational Site Number : 5280001

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Investigational Site Number : 5280002

Rotterdam, 3015 CE, Netherlands

RECRUITING

Investigational Site Number : 6160006

Krakow, Lesser Poland Voivodeship, 31-501, Poland

RECRUITING

Investigational Site Number : 6160002

Lublin, Lublin Voivodeship, 20-016, Poland

RECRUITING

Investigational Site Number : 6160003

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

RECRUITING

Investigational Site Number : 6200005

Coimbra, 3000-075, Portugal

RECRUITING

Investigational Site Number : 6200004

Lisbon, 1150-199, Portugal

RECRUITING

Investigational Site Number : 6200001

Lisbon, 1349-019, Portugal

RECRUITING

Investigational Site Number : 6200003

Matosinhos Municipality, 4464-513, Portugal

RECRUITING

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, 02841, South Korea

RECRUITING

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 05505, South Korea

RECRUITING

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 06351, South Korea

RECRUITING

Investigational Site Number : 7240012

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

RECRUITING

Investigational Site Number : 7240008

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240007

Bilbao, Basque Country, 48013, Spain

RECRUITING

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], 08041, Spain

RECRUITING

Investigational Site Number : 7240006

Majadahonda, Madrid, 28222, Spain

RECRUITING

Investigational Site Number : 7240003

Pamplona, Navarre, 31008, Spain

RECRUITING

Investigational Site Number : 7240005

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Investigational Site Number : 7240009

Sabadell, 08208, Spain

RECRUITING

Investigational Site Number : 7240010

Santa Cruz de Tenerife, 38010, Spain

RECRUITING

Investigational Site Number : 7240002

Valencia, 46026, Spain

RECRUITING

Investigational Site Number : 7520001

Stockholm, 113 65, Sweden

RECRUITING

Investigational Site Number : 1580003

Kaohsiung City, 833, Taiwan

RECRUITING

Investigational Site Number : 1580001

Taipei, 100, Taiwan

RECRUITING

Investigational Site Number : 1580002

Taipei, 112, Taiwan

RECRUITING

Investigational Site Number : 7920006

Ankara, 06170, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920002

Bursa, 16059, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920001

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920004

Istanbul, 34785, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920003

Konya, 42075, Turkey (Türkiye)

RECRUITING

Related Links

• EFC18156 (Vitalize) \& EFC17236 (MOBILIZE) CIDP website-for potential participants
• EFC17236 Plain Language Results Summary

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Autoimmune Diseases of the Nervous System; Nervous System Diseases

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double-blind treatment in part A and open-label treatment in Part B.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): November 20, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (9); CL (3); BE (1); NL (2); ES (10); TW (3); BR (5); AR (3); PL (3); DK (2); FR (5); PT (4); GR (3); CA (1); CN (16); BU (2); KR (3); SE (1); ME (3); TU (5); DE (5); IT (9); US (24); CZ (3)