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) (VITALIZE)

May 28, 2026 updated by: Sanofi

A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Recruiting
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1221
        • Recruiting
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentina, 1015
        • Recruiting
        • Investigational Site Number : 0320001
  • Belgium
      • Ghent, Belgium, 9000
        • Completed
        • Investigational Site Number : 0560002
      • Leuven, Belgium, 3000
        • Recruiting
        • Investigational Site Number : 0560001
  • Brazil
      • São Paulo, Brazil, 04038-002
        • Recruiting
        • PSEG Centro de Pesquisa Clínica- Site Number : 0760009
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Recruiting
        • L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-320
        • Recruiting
        • Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760016
    • Paraná
      • Curitiba, Paraná, Brazil, 81210-310
        • Recruiting
        • Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Recruiting
        • InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • Investigational Site Number : 1240003
    • Quebec
      • Montreal, Quebec, Canada, H3a 2b4
        • Recruiting
        • Investigational Site Number : 1240006
      • Québec, Quebec, Canada, G1E 7G9
        • Recruiting
        • Investigational Site Number : 1240001
  • China
      • Beijing, China, 100034
        • Recruiting
        • Investigational Site Number : 1560013
      • Beijing, China, 100053
        • Recruiting
        • Investigational Site Number : 1560005
      • Beijing, China, 100050
        • Recruiting
        • Investigational Site Number : 1560010
      • Beijing, China, 100730
        • Recruiting
        • Investigational Site Number : 1560017
      • Changsha, China, 410008
        • Recruiting
        • Investigational Site Number : 1560009
      • Chengdu, China, 610072
        • Recruiting
        • Investigational Site Number : 1560011
      • Fuzhou, China, 350001
        • Recruiting
        • Investigational Site Number : 1560002
      • Guangzhou, China, 510080
        • Recruiting
        • Investigational Site Number : 1560007
      • Guangzhou, China, 510000
        • Recruiting
        • Investigational Site Number : 1560012
      • Hangzhou, China, 310003
        • Recruiting
        • Investigational Site Number : 1560014
      • Jiazhuang, China, 050000
        • Recruiting
        • Investigational Site Number : 1560016
      • Jinan, China, 250014
        • Recruiting
        • Investigational Site Number : 1560008
      • Nanchang, China, 330006
        • Recruiting
        • Investigational Site Number : 1560015
      • Shanghai, China, 200040
        • Recruiting
        • Investigational Site Number : 1560001
      • Wuhan, China, 430030
        • Recruiting
        • Investigational Site Number : 1560003
      • Wuhan, China, 430060
        • Recruiting
        • Investigational Site Number : 1560006
      • Xi'an, China, 710038
        • Recruiting
        • Investigational Site Number : 1560004
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Investigational Site Number : 2030004
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Investigational Site Number : 2030003
      • Ostrava, Czechia, 708 52
        • Recruiting
        • Investigational Site Number : 2030005
      • Pardubice, Czechia, 532 03
        • Completed
        • Investigational Site Number : 2030002
      • Prague, Czechia, 128 08
        • Recruiting
        • Investigational Site Number : 2030001
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Investigational Site Number : 2080002
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Investigational Site Number : 2080001
  • France
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Investigational Site Number : 2500001
      • Marseille, France, 13885
        • Recruiting
        • Investigational Site Number : 2500002
      • Nice, France, 06001
        • Recruiting
        • Investigational Site Number : 2500005
      • Paris, France, 75013
        • Recruiting
        • Investigational Site Number : 2500003
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Investigational Site Number : 2760003
      • Bochum, Germany, 44791
        • Recruiting
        • Investigational Site Number : 2760008
      • Essen, Germany, 45147
        • Recruiting
        • Investigational Site Number : 2760007
      • Göttingen, Germany, 37075
        • Recruiting
        • Investigational Site Number : 2760006
      • Hanover, Germany, 30625
        • Recruiting
        • Investigational Site Number : 2760005
      • Münster, Germany, 48149
        • Recruiting
        • Investigational Site Number : 2760001
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Investigational Site Number : 3480003
      • Budapest, Hungary, 1125
        • Recruiting
        • Investigational Site Number : 3480005
      • Győr, Hungary, 9024
        • Recruiting
        • Investigational Site Number : 3480004
      • Szeged, Hungary, 6720
        • Recruiting
        • Investigational Site Number : 3480001
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Investigational Site Number : 3760001
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • Investigational Site Number : 3800002
    • Milano
      • Milan, Milano, Italy, 20132
        • Recruiting
        • Investigational Site Number : 3800004
        • Principal Investigator:
          • Stefano Previtali
        • Contact:
    • Padova
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Investigational Site Number : 3920001
      • Saga, Japan, 849-0937
        • Recruiting
        • Investigational Site Number : 3920009
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660-8511
        • Recruiting
        • Investigational Site Number : 3920007
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 222-0036
        • Recruiting
        • Investigational Site Number : 3920015
    • Saitama
      • Higashi-Matsuyama, Saitama, Japan, 355-0005
        • Recruiting
        • Investigational Site Number : 3920012
      • Kawagoe, Saitama, Japan, 350-8550
        • Recruiting
        • Investigational Site Number : 3920005
    • Shizuoka
      • Yaizu, Shizuoka, Japan, 425-8505
        • Recruiting
        • Investigational Site Number : 3920014
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-8551
        • Recruiting
        • Investigational Site Number : 3920008
      • Ōta-ku, Tokyo, Japan, 143-8541
        • Recruiting
        • Investigational Site Number : 3920010
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigational Site Number : 4840002
      • Tlalnepantla, Mexico, 54055
        • Recruiting
        • Investigational Site Number : 4840001
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Investigational Site Number : 5780001
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Investigational Site Number : 6200003
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Investigational Site Number : 6200005
      • Lisbon, Portugal, 1349-019
        • Recruiting
        • Investigational Site Number : 6200001
      • Lisbon, Portugal, 1150-199
        • Recruiting
        • Investigational Site Number : 6200002
  • Spain
      • Málaga, Spain, 29010
        • Recruiting
        • Investigational Site Number : 7240007
      • Santa Cruz de Tenerife, Spain, 38010
        • Recruiting
        • Investigational Site Number : 7240010
      • Valencia, Spain, 46026
        • Recruiting
        • Investigational Site Number : 7240004
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
        • Recruiting
        • Investigational Site Number : 7240012
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Investigational Site Number : 7240009
      • Sabadell, Barcelona [Barcelona], Spain, 08208
        • Recruiting
        • Investigational Site Number : 7240006
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08041
        • Recruiting
        • Investigational Site Number : 7240001
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Investigational Site Number : 7240008
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Investigational Site Number : 7240002
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Investigational Site Number : 7240003
  • Sweden
      • Stockholm, Sweden, 113 65
        • Recruiting
        • Investigational Site Number : 7520001
  • Switzerland
      • Basel, Switzerland, 4056
        • Recruiting
        • Investigational Site Number : 7560001
      • Bern, Switzerland, 3010
        • Recruiting
        • Investigational Site Number : 7560003
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Investigational Site Number : 1580003
      • Taipei, Taiwan, 100
        • Recruiting
        • Investigational Site Number : 1580001
      • Taipei, Taiwan, 112
        • Recruiting
        • Investigational Site Number : 1580002
  • Turkey (Türkiye)
      • Bursa, Turkey (Türkiye), 16059
        • Recruiting
        • Investigational Site Number : 7920004
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Investigational Site Number : 7920001
      • Istanbul, Turkey (Türkiye), 34785
        • Recruiting
        • Investigational Site Number : 7920002
      • Konya, Turkey (Türkiye), 42075
        • Recruiting
        • Investigational Site Number : 7920003
  • United Kingdom
    • England
      • London, England, United Kingdom, E1 1BB
        • Recruiting
        • Investigational Site Number : 8260007
    • Highland
      • Inverness, Highland, United Kingdom, IV2 3UJ
        • Recruiting
        • Investigational Site Number : 8260003
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Investigational Site Number : 8260001
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Alabama Neurology Associates- Site Number : 8400019
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck School of Medicine of University of Southern California- Site Number : 8400002
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center- Site Number : 8400007
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine- Site Number : 8400018
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Nova Clinical Research - Bradenton- Site Number : 8400044
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando- Site Number : 8400006
      • Orlando, Florida, United States, 32804-5558
        • Recruiting
        • AdventHealth Site Number : 8400006
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center- Site Number : 8400010
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital- Site Number : 8400015
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital- Site Number : 8400009
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital- Site Number : 8400025
      • East Lansing, Michigan, United States, 48824
        • Recruiting
        • Michigan State University- Site Number : 8400038
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Profound Research- Site Number : 8400052
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute - Amherst- Site Number : 8400039
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center- Site Number : 8400003
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery- Site Number : 8400041
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Raleigh Neurology Associates- Site Number : 8400043
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center- Site Number : 8400020
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center- Site Number : 8400033
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Milton South Hershey Medical Center- Site Number : 8400042
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
    • Texas
      • Austin, Texas, United States, 78756
        • Recruiting
        • Austin Neuromuscular Center- Site Number : 8400040
      • Houston, Texas, United States, 77054
        • Recruiting
        • UTHealth - The University of Texas Health Sciences Center at Houston- Site Number : 8400050
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center- Site Number : 8400012
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia- Site Number : 8400023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Riliprubart Arm
Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Drug: riliprubart
Pharmaceutical form: Solution Route of administration: IV solution
Other Names:
  • SAR445088
Drug: Placebo
Pharmaceutical form: Solution Route of administration: IV solution
Drug: riliprubart
Pharmaceutical form: Solution Route of administration: SC solution
Other Names:
  • SAR445088
Drug: Placebo
Pharmaceutical form: Solution Route of administration: SC solution
Drug: Placebo
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Active Comparator: IVIg Arm
IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Drug: riliprubart
Pharmaceutical form: Solution Route of administration: IV solution
Other Names:
  • SAR445088
Drug: Placebo
Pharmaceutical form: Solution Route of administration: IV solution
Drug: riliprubart
Pharmaceutical form: Solution Route of administration: SC solution
Other Names:
  • SAR445088
Drug: Placebo
Pharmaceutical form: Solution Route of administration: SC solution
Drug: Placebo
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Drug: IVIg
Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants experiencing a response
Time Frame: Baseline to week 24
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
Time Frame: Baseline to week 48
Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score
Baseline to week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score
Time Frame: Baseline to week 24
Baseline to week 24
Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)
Time Frame: Baseline to week 24
Baseline to week 24
Change from baseline in adjusted INCAT score
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in grip strength (kilopascals; dominant hand)
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in MRC-SS
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in EQ-5D-5L score
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in RT-FSS
Time Frame: Baseline to week 48
Baseline to week 48
Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score
Time Frame: Baseline to week 24
Baseline to week 24
Change from baseline in grip strength (kilopascals, dominant hand)
Time Frame: Baseline to week 24
Baseline to week 24
Change from baseline in Medical Research Council Sum Score (MRC-SS)
Time Frame: Baseline to week 24
Baseline to week 24
Percentage of participants experiencing a relapse
Time Frame: Baseline to week 24
A relapse is defined as increase of ≥1 point from baseline in adjusted INCAT disability score
Baseline to week 24
Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)
Time Frame: Baseline to week 24
Baseline to week 24
Number of participants with treatment-emergent ADA in participants treated with riliprubart
Time Frame: Baseline to week 24
Baseline to week 24
Number of participants with TEAEs, including SAEs and AESIs
Time Frame: Week 24 to week 48
Week 24 to week 48
Change from baseline in I-RODS
Time Frame: Baseline to week 48
Baseline to week 48
Number of participants with TEAEs, including SAEs and AESIs for Part A
Time Frame: Baseline to week 24
Baseline to week 24
Incidence and titer of anti-drug antibodies (ADA) during open-label treatment and follow-up
Time Frame: Baseline to week 109
Baseline to week 109
Percentage of participants randomized to IVIg continuation who experienced a response
Time Frame: Week 24 to week 48
A response is defined as a decrease of ≥1 point in adjusted INCAT disability scale score at Week 48 versus Week 24
Week 24 to week 48
Percentage of participants randomized to riliprubart who experienced a response at Week 48 without prior response in Part A (delayed response)
Time Frame: Baseline to Week 48
A delayed response is defined as an decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus Baseline
Baseline to Week 48
Percentage of participants randomized to riliprubart experiencing a relapse
Time Frame: Baseline to week 48
A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Baseline
Baseline to week 48
Percentage of participants randomized to IVIg continuation experiencing a relapse
Time Frame: Week 24 to week 48
A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Week 24
Week 24 to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

July 9, 2027

Study Completion (Estimated)

January 12, 2029

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC18156
  • U1111-1295-3363 (Registry Identifier: ICTRP)
  • 2023-508338-33 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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