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)

NCT06290141 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC18156U1111-1295-33632023-508338-33
• Study Type: interventional
• Target: 160
• Locations: 23 countries
• Sites: 118

Brief 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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (2)

• Percentage of participants experiencing a response

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

  Baseline to week 24

• Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period

  Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score

  Baseline to week 48

Secondary Outcomes (21)

• Change from baseline in Rasch-built Overall Disability Scale (I-RODS) 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

• Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)

  Baseline to week 24

Study Arms (2)

Riliprubart Arm

EXPERIMENTAL

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

Drug: riliprubart; Drug: Placebo

IVIg Arm

ACTIVE COMPARATOR

IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

Drug: Placebo; Drug: riliprubart; Drug: IVIg

Interventions

Placebo DRUG

Pharmaceutical form: Solution Route of administration: IV solution

IVIg Arm

riliprubart DRUG

Pharmaceutical form: Solution Route of administration: IV solution

Also known as: SAR445088

Riliprubart Arm

IVIg DRUG

Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution

IVIg 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 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.

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 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (118)

Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama, 35209, United States

RECRUITING

Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014

Scottsdale, Arizona, 85251, United States

RECRUITING

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

Los Angeles, California, 90033, United States

RECRUITING

University of California Irvine Medical Center- Site Number : 8400007

Orange, California, 92868, United States

RECRUITING

Yale University School of Medicine- Site Number : 8400018

New Haven, Connecticut, 06510, United States

RECRUITING

Nova Clinical Research - Bradenton- Site Number : 8400044

Bradenton, Florida, 34209, United States

RECRUITING

AdventHealth Orlando- Site Number : 8400006

Orlando, Florida, 32803, United States

RECRUITING

AdventHealth Site Number : 8400006

Orlando, Florida, 32804-5558, United States

RECRUITING

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

Glenview, Illinois, 60026, United States

RECRUITING

University of Kansas Medical Center- Site Number : 8400010

Kansas City, Kansas, 66103, 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

Dent Neurologic Institute - Amherst- Site Number : 8400039

Amherst, New York, 14226, 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 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 : 0560002

Ghent, 9000, Belgium

COMPLETED

Investigational Site Number : 0560001

Leuven, 3000, Belgium

RECRUITING

L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006

Brasília, Federal District, 70200-730, Brazil

RECRUITING

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

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

PSEG Centro de Pesquisa Clínica- Site Number : 0760009

São Paulo, 04038-002, Brazil

RECRUITING

Investigational Site Number : 1240003

London, Ontario, N6A 5A5, Canada

RECRUITING

Investigational Site Number : 1240006

Montreal, Quebec, H3a 2b4, Canada

RECRUITING

Investigational Site Number : 1240001

Québec, Quebec, G1E 7G9, Canada

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 : 1560017

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 : 1560016

Jiazhuang, 050000, 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 : 2030005

Ostrava, 708 52, Czechia

RECRUITING

Investigational Site Number : 2030002

Pardubice, 532 03, Czechia

COMPLETED

Investigational Site Number : 2030001

Prague, 128 08, Czechia

RECRUITING

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 : 2500002

Marseille, 13885, France

RECRUITING

Investigational Site Number : 2500005

Nice, 06001, France

RECRUITING

Investigational Site Number : 2500003

Paris, 75013, France

RECRUITING

Investigational Site Number : 2760003

Berlin, 10117, Germany

RECRUITING

Investigational Site Number : 2760008

Bochum, 44791, Germany

RECRUITING

Investigational Site Number : 2760006

Göttingen, 37075, Germany

RECRUITING

Investigational Site Number : 2760005

Hanover, 30625, Germany

RECRUITING

Investigational Site Number : 2760001

Münster, 48149, Germany

RECRUITING

Investigational Site Number : 3480003

Budapest, 1085, Hungary

RECRUITING

Investigational Site Number : 3480004

Győr, 9024, Hungary

RECRUITING

Investigational Site Number : 3480001

Szeged, 6720, Hungary

RECRUITING

Investigational Site Number : 3760001

Haifa, 3109601, Israel

RECRUITING

Investigational Site Number : 3800004

Milan, Milano, 20132, Italy

RECRUITING

Investigational Site Number : 3800001

Padua, Padova, 35128, Italy

RECRUITING

Investigational Site Number : 3800002

Bologna, 40139, Italy

RECRUITING

Investigational Site Number : 3920007

Amagasaki, Hyōgo, 660-8511, Japan

RECRUITING

Investigational Site Number : 3920015

Yokohama, Kanagawa, 222-0036, Japan

RECRUITING

Investigational Site Number : 3920012

Higashi-Matsuyama, Saitama, 355-0005, 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 : 3920008

Kodaira, Tokyo, 187-8551, Japan

RECRUITING

Investigational Site Number : 3920010

Ōta-ku, Tokyo, 143-8541, Japan

RECRUITING

Investigational Site Number : 3920001

Chiba, 260-8677, Japan

RECRUITING

Investigational Site Number : 3920009

Saga, 849-0937, Japan

RECRUITING

Investigational Site Number : 4840002

Chihuahua City, 31000, Mexico

RECRUITING

Investigational Site Number : 4840001

Tlalnepantla, 54055, Mexico

RECRUITING

Investigational Site Number : 5780001

Oslo, 0450, Norway

RECRUITING

Investigational Site Number : 6200003

Braga, 4710-243, Portugal

RECRUITING

Investigational Site Number : 6200005

Coimbra, 3000-075, Portugal

RECRUITING

Investigational Site Number : 6200002

Lisbon, 1150-199, Portugal

RECRUITING

Investigational Site Number : 6200001

Lisbon, 1349-019, Portugal

RECRUITING

Investigational Site Number : 7240012

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

RECRUITING

Investigational Site Number : 7240009

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240006

Sabadell, Barcelona [Barcelona], 08208, Spain

RECRUITING

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], 08041, Spain

RECRUITING

Investigational Site Number : 7240008

Majadahonda, Madrid, 28222, Spain

RECRUITING

Investigational Site Number : 7240002

Pamplona, Navarre, 31008, Spain

RECRUITING

Investigational Site Number : 7240003

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Investigational Site Number : 7240007

Málaga, 29010, Spain

RECRUITING

Investigational Site Number : 7240010

Santa Cruz de Tenerife, 38010, Spain

RECRUITING

Investigational Site Number : 7240004

Valencia, 46026, Spain

RECRUITING

Investigational Site Number : 7520001

Stockholm, 113 65, Sweden

RECRUITING

Investigational Site Number : 7560001

Basel, 4056, Switzerland

RECRUITING

Investigational Site Number : 7560003

Bern, 3010, Switzerland

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 : 7920004

Bursa, 16059, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920001

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920002

Istanbul, 34785, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920003

Konya, 42075, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 8260007

London, England, E1 1BB, United Kingdom

RECRUITING

Investigational Site Number : 8260003

Inverness, Highland, IV2 3UJ, United Kingdom

RECRUITING

Investigational Site Number : 8260001

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Related Links

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

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; 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

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: Part A is a double-blind treatment period and Part B is an open-label period.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): January 12, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CH (2); BE (2); IL (1); CA (3); IT (3); JP (9); TW (3); BR (4); PT (4); US (27); CN (17); DK (2); CZ (5); FR (4); GB (3); NO (1); ME (2); DE (5); HU (3); SE (1); TU (4); AR (3); ES (10)