AzTrials
AzTrials

Chronic Inflammatory Demyelinating PolyneuropathyPhase 3VITALIZENCT06290141

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)

A Phase 3 study testing riliprubart and IVIg in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Sanofi at 134 sites in 24 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
riliprubart and IVIg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
134 sitesin 24 countries
Study dates
21 Aug 2024to 12 Jan 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

134 sites in 24 countries. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

contact-us@sanofi.com

134 sites in 24 countries

United States32 sites, 32 recruiting

  • Dent Neurologic Institute - Amherst- Site Number : 8400039

    Amherst, New York, 14226

    Recruiting

  • Austin Neuromuscular Center- Site Number : 8400040

    Austin, Texas, 78756

    Recruiting

  • Wilmer Instit John Hopkins Hosp Univ Sch Medicine- Site Number : 8400015

    Baltimore, Maryland, 21287

    Recruiting

  • Gadolin Research - Beaumont- Site Number : 8400047

    Beaumont, Texas, 77702

    Recruiting

  • Massachusetts General Hospital-Genetics- Site Number : 8400009

    Boston, Massachusetts, 02114

    Recruiting

  • DM Clinical Research - Bradenton- Site Number : 8400044

    Bradenton, Florida, 34209

    Recruiting

  • University of Vermont Medical Center- Site Number : 8400012

    Burlington, Vermont, 05401

    Recruiting

  • IMMUNOe International Research Centers - Centennial- Site Number : 8400049

    Centennial, Colorado, 80112

    Recruiting

  • University of Virginia- Site Number : 8400023

    Charlottesville, Virginia, 22908

    Recruiting

  • University of Cincinnati Medical Center- Site Number : 8400020

    Cincinnati, Ohio, 45219

    Recruiting

  • University Hospitals Cleveland Medical Center- Site Number : 8400033

    Cleveland, Ohio, 44106

    Recruiting

  • Henry Ford Hospital- Site Number : 8400025

    Detroit, Michigan, 48202

    Recruiting

  • Michigan State University- Site Number : 8400038

    East Lansing, Michigan, 48824

    Recruiting

  • Yale University School Of Medicine Department Of Neurology- Site Number : 8400018

    Fairfield, Connecticut, 06824

    Recruiting

  • Endeavor Health - NorthShore Kellogg Cancer Center - Glenbrook- Site Number : 8400024

    Glenview, Illinois, 60026

    Recruiting

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

    Hershey, Pennsylvania, 17033

    Recruiting

  • Alabama Neurology Associates- Site Number : 8400019

    Homewood, Alabama, 35209

    Recruiting

  • Uthealth - The University Of Texas Health Sciences Center At Houston- Site Number : 8400050

    Houston, Texas, 77054

    Recruiting

  • University of Kansas Medical Center- Site Number : 8400010

    Kansas City, Kansas, 66160

    Recruiting

  • Northwell Health Physician Partners Dermatology at Lake Success- Site Number : 8400051

    Lake Success, New York, 11042

    Recruiting

  • Profound Research- Site Number : 8400052

    Las Vegas, Nevada, 89106

    Recruiting

  • University Of Southern California- Site Number : 8400002

    Los Angeles, California, 90032

    Recruiting

  • Research by Design, LLC- Site Number : 8400053

    Miami Lakes, Florida, 33016

    Recruiting

  • Ochsner Medical Center - Jefferson Highway- Site Number : 8400030

    New Orleans, Louisiana, 70121

    Recruiting

  • Hospital for Special Surgery - Site Number : 8400041

    New York, New York, 10021

    Recruiting

  • Columbia University Irving Medical Center- Site Number : 8400003

    New York, New York, 10032

    Recruiting

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

    Orange, California, 92868

    Recruiting

  • AdventHealth Orlando- Site Number : 8400006

    Orlando, Florida, 32803

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Raleigh Neurology Associates- Site Number : 8400043

    Raleigh, North Carolina, 27607

    Recruiting

  • HonorHealth Bob Bove Neuroscience Institute - Site Number : 8400014

    Scottsdale, Arizona, 85251

    Recruiting

  • Washington University School of Medicine- Site Number : 8400037

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

China16 sites, 14 recruiting

  • Investigational Site Number : 1560013

    Beijing, 100034

    Recruiting

  • Investigational Site Number : 1560005

    Beijing, 100053

    Recruiting

  • Investigational Site Number : 1560010

    Beijing, 100071

    Recruiting

  • Investigational Site Number : 1560017

    Beijing, 100730

    Recruiting

  • Investigational Site Number : 1560009

    Changsha, 410008

    Recruiting

  • Investigational Site Number : 1560011

    Chengdu, 610072

    Recruiting

  • Investigational Site Number : 1560002

    Fuzhou, 350001

    Active, not recruiting

  • Investigational Site Number : 1560012

    Guangzhou, 510000

    Recruiting

  • Investigational Site Number : 1560007

    Guangzhou, 510080

    Recruiting

  • Investigational Site Number : 1560016

    Jiazhuang, 050000

    Active, not recruiting

  • Investigational Site Number : 1560008

    Jinan, 250014

    Recruiting

  • Investigational Site Number : 1560015

    Nanchang, 330209

    Recruiting

  • Investigational Site Number : 1560001

    Shanghai, 200040

    Recruiting

  • Investigational Site Number : 1560003

    Wuhan, 430030

    Recruiting

  • Investigational Site Number : 1560006

    Wuhan, 430060

    Recruiting

  • Investigational Site Number : 1560004

    Xi'an, 710038

    Recruiting

Other trials in China

Germany9 sites, 9 recruiting

  • Investigational Site Number : 2760003

    Berlin, 10117

    Recruiting

  • Investigational Site Number : 2760008

    Bochum, 44791

    Recruiting

  • Investigational Site Number : 2760010

    Bremen, 28325

    Recruiting

  • Investigational Site Number : 2760007

    Essen, 45147

    Recruiting

  • Investigational Site Number : 2760006

    Göttingen, 37075

    Recruiting

  • Investigational Site Number : 2760005

    Hanover, 30625

    Recruiting

  • Investigational Site Number : 2760009

    Homburg, 66421

    Recruiting

  • Investigational Site Number : 2760001

    Münster, 48149

    Recruiting

  • Investigational Site Number : 2760011

    Schwäbisch Hall, 74523

    Recruiting

Other trials in Germany

Japan9 sites, 9 recruiting

  • Investigational Site Number : 3920007

    Amagasaki, 660-8511

    Recruiting

  • Investigational Site Number : 3920001

    Chiba, 260-8677

    Recruiting

  • Investigational Site Number : 3920012

    Higashi-Matsuyama, Saitama, 355-0005

    Recruiting

  • Investigational Site Number : 3920005

    Kawagoe, Saitama, 350-8550

    Recruiting

  • Investigational Site Number : 3920008

    Kodaira, Tokyo, 187-8551

    Recruiting

  • Investigational Site Number : 3920010

    Ōta-ku, Tokyo, 143-8541

    Recruiting

  • Investigational Site Number : 3920009

    Saga, 849-0937

    Recruiting

  • Investigational Site Number : 3920014

    Yaizu, Shizuoka, 425-8505

    Recruiting

  • Investigational Site Number : 3920015

    Yokohama, Kanagawa, 222-0036

    Recruiting

Other trials in Japan

Spain9 sites, 9 recruiting

  • Investigational Site Number : 7240009

    Barcelona, Catalunya [Cataluña], 08035

    Recruiting

  • Investigational Site Number : 7240001

    Barcelona, Catalunya [Cataluña], 08041

    Recruiting

  • Investigational Site Number : 7240008

    Majadahonda, Madrid, 28222

    Recruiting

  • Investigational Site Number : 7240007

    Málaga, 29010

    Recruiting

  • Investigational Site Number : 7240002

    Pamplona, Navarre, 31008

    Recruiting

  • Investigational Site Number : 7240006

    Sabadell, 08208

    Recruiting

  • Investigational Site Number : 7240010

    Santa Cruz de Tenerife, 38010

    Recruiting

  • Investigational Site Number : 7240012

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

    Recruiting

  • Investigational Site Number : 7240004

    Valencia, 46026

    Recruiting

Other trials in Spain

Brazil6 sites, 6 recruiting

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

    Belo Horizonte, Minas Gerais, 30150-320

    Recruiting

  • L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006

    Brasília, Federal District, 70200-730

    Recruiting

  • Fundação Universidade Federal de Mato Grosso do Sul- Site Number : 0760020

    Campo Grande, Mato Grosso do Sul, 79040-010

    Recruiting

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

    Curitiba, Paraná, 81210-310

    Recruiting

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

    Porto Alegre, Rio Grande do Sul, 90610-000

    Recruiting

  • PSEG Centro de Pesquisa Clínica- Site Number : 0760009

    São Paulo, 04038-002

    Recruiting

Other trials in Brazil

Czechia5 sites, 4 recruiting

  • Investigational Site Number : 2030004

    Brno, 625 00

    Recruiting

  • Investigational Site Number : 2030003

    Hradec Králové, 500 05

    Recruiting

  • Investigational Site Number : 2030005

    Ostrava, 708 52

    Recruiting

  • Investigational Site Number : 2030002

    Pardubice, 532 03

    Completed

  • Investigational Site Number : 2030001

    Prague, 128 08

    Recruiting

Other trials in Czechia

France5 sites, 5 recruiting

  • Investigational Site Number : 2500001

    Le Kremlin-Bicêtre, 94270

    Recruiting

  • Investigational Site Number : 2500006

    Lille, 59037

    Recruiting

  • Investigational Site Number : 2500002

    Marseille, 13885

    Recruiting

  • Investigational Site Number : 2500005

    Nice, 06001

    Recruiting

  • Investigational Site Number : 2500003

    Paris, 75013

    Recruiting

Other trials in France

Italy5 sites, 5 recruiting

  • Investigational Site Number : 3800002

    Bologna, 40139

    Recruiting

  • Investigational Site Number : 3800004

    Milan, Milano, 20132

    Yuri Falzone, 003902264321312, falzone.yuri@hsr.it

    Stefano Previtali

    Recruiting

  • Investigational Site Number : 3800003

    Milan, Milano, 20133

    Recruiting

  • Investigational Site Number : 3800001

    Padua, Padova, 35128

    Alessandro Salvalaggio, alessandro.salvalaggio@unipd.it

    Recruiting

  • Investigational Site Number : 3800005

    Rozzano, Milano, 20089

    Pietro Doneddu, +3934312740, pietro.doneddu@hunimed.it

    +39 0282247662, mariaconcetta.sergi@humanitas.it

    Recruiting

Other trials in Italy

Portugal5 sites, 5 recruiting

  • Investigational Site Number : 6200003

    Braga, 4710-243

    Recruiting

  • Investigational Site Number : 6200005

    Coimbra, 3000-075

    Recruiting

  • Investigational Site Number : 6200002

    Lisbon, 1150-199

    Recruiting

  • Investigational Site Number : 6200001

    Lisbon, 1349-019

    Recruiting

  • Investigational Site Number : 6200006

    Lisbon, 1649-035

    Recruiting

Other trials in Portugal

Canada4 sites, 4 recruiting

  • Investigational Site Number : 1240003

    London, Ontario, N6A 5A5

    Recruiting

  • Investigational Site Number : 1240006

    Montreal, Quebec, H3a 2b4

    Recruiting

  • Investigational Site Number : 1240001

    Québec, Quebec, G1E 7G9

    Recruiting

  • Investigational Site Number : 1240002

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

Hungary4 sites, 4 recruiting

  • Investigational Site Number : 3480003

    Budapest, 1085

    Recruiting

  • Investigational Site Number : 3480005

    Budapest, 1125

    Recruiting

  • Investigational Site Number : 3480004

    Győr, 9024

    Recruiting

  • Investigational Site Number : 3480001

    Szeged, 6720

    Recruiting

Other trials in Hungary

Argentina3 sites, 3 recruiting

  • Investigational Site Number : 0320001

    Buenos Aires, 1015

    Recruiting

  • Investigational Site Number : 0320002

    Buenos Aires, 1181

    Recruiting

  • Investigational Site Number : 0320003

    Buenos Aires, 1221

    Recruiting

Other trials in Argentina

Taiwan3 sites, 3 recruiting

  • Investigational Site Number : 1580003

    Kaohsiung City, 833

    Recruiting

  • Investigational Site Number : 1580001

    Taipei, 100

    Recruiting

  • Investigational Site Number : 1580002

    Taipei, 112

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)3 sites, 3 recruiting

  • Investigational Site Number : 7920001

    Istanbul, 34093

    Recruiting

  • Investigational Site Number : 7920002

    Istanbul, 34785

    Recruiting

  • Investigational Site Number : 7920003

    Konya, 42075

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom3 sites, 3 recruiting

  • Investigational Site Number : 8260003

    Inverness, Highland, IV2 3UJ

    Recruiting

  • Investigational Site Number : 8260007

    London, England, E1 1BB

    Recruiting

  • Investigational Site Number : 8260001

    Oxford, Oxfordshire, OX3 9DU

    Recruiting

Other trials in United Kingdom

Belgium2 sites, 1 recruiting

  • Investigational Site Number : 0560002

    Ghent, 9000

    Completed

  • Investigational Site Number : 0560001

    Leuven, 3000

    Recruiting

Other trials in Belgium

Denmark2 sites, 2 recruiting

  • Investigational Site Number : 2080002

    Aarhus, 8200

    Recruiting

  • Investigational Site Number : 2080001

    Copenhagen, 2100

    Recruiting

Other trials in Denmark

Greece2 sites, 2 recruiting

  • Investigational Site Number : 3000001

    Athens, 124 62

    Recruiting

  • Investigational Site Number : 3000002

    Thessaloniki, 546 36

    Recruiting

Other trials in Greece

Mexico2 sites, 1 recruiting

  • Investigational Site Number : 4840002

    Chihuahua City, 31000

    Completed

  • Investigational Site Number : 4840001

    Tlalnepantla, 54055

    Recruiting

Other trials in Mexico

Switzerland2 sites, 2 recruiting

  • Investigational Site Number : 7560001

    Basel, 4031

    Recruiting

  • Investigational Site Number : 7560003

    Bern, 3010

    Recruiting

Other trials in Switzerland

Israel1 site, 1 recruiting

  • Investigational Site Number : 3760001

    Haifa, 3109601

    Recruiting

Other trials in Israel

Norway1 site, 1 recruiting

  • Investigational Site Number : 5780001

    Oslo, 0450

    Recruiting

Other trials in Norway

Sweden1 site, 1 recruiting

  • Investigational Site Number : 7520001

    Stockholm, 113 65

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

Being tested
riliprubart, Placebo, IVIg
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • riliprubartDrug

    Also called SAR445088

    Pharmaceutical form: Solution Route of administration: IV solution

  • PlaceboDrug

    Pharmaceutical form: Solution Route of administration: IV solution

  • riliprubartDrug

    Also called SAR445088

    Pharmaceutical form: Solution Route of administration: SC solution

  • PlaceboDrug

    Pharmaceutical form: Solution Route of administration: SC solution

  • IVIgDrug

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

  • PlaceboDrug

    Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution

Study groups in NCT06290141
Study groupRoleWhat they receive
Riliprubart ArmExperimentalRiliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Receives: Drug: riliprubart; Drug: Placebo
IVIg ArmActive comparatorIVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Receives: Drug: Placebo; Drug: riliprubart; Drug: IVIg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to week 24

  2. 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

    Measured: Baseline to week 48

Secondary outcomes (21)

  1. Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score

    Measured: Baseline to week 24

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

    Measured: Baseline to week 24

  3. Change from baseline in grip strength (kilopascals, dominant hand)

    Measured: Baseline to week 24

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

    Measured: Baseline to week 24

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

    Measured: Baseline to week 24

  6. Percentage of participants experiencing a relapse

    A relapse is defined as increase of ≥1 point from baseline in adjusted INCAT disability score

    Measured: Baseline to week 24

  7. Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)

    Measured: Baseline to week 24

  8. Number of participants with TEAEs, including SAEs and AESIs for Part A

    Measured: Baseline to week 24

  9. Number of participants with treatment-emergent ADA in participants treated with riliprubart

    Measured: Baseline to week 24

  10. Number of participants with TEAEs, including SAEs and AESIs

    Measured: Week 24 to week 48

  11. Incidence and titer of anti-drug antibodies (ADA) during open-label treatment and follow-up

    Measured: Baseline to week 109

  12. Change from baseline in I-RODS

    Measured: Baseline to week 48

  13. Change from baseline in adjusted INCAT score

    Measured: Baseline to week 48

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

    Measured: Baseline to week 48

  15. Change from baseline in MRC-SS

    Measured: Baseline to week 48

  16. Change from baseline in EQ-5D-5L score

    Measured: Baseline to week 48

  17. Percentage of participants randomized to IVIg continuation who experienced a response

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

    Measured: Week 24 to week 48

  18. Percentage of participants randomized to riliprubart who experienced a response at Week 48 without prior response in Part A (delayed response)

    A delayed response is defined as an decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus Baseline

    Measured: Baseline to Week 48

  19. Percentage of participants randomized to riliprubart experiencing a relapse

    A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Baseline

    Measured: Baseline to week 48

  20. Percentage of participants randomized to IVIg continuation experiencing a relapse

    A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Week 24

    Measured: Week 24 to week 48

  21. Change from baseline in RT-FSS

    Measured: Baseline to week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start21 Aug 2024
  3. Primary completion9 Jul 2027 (estimated)
  4. Study completion12 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part A is a double-blind treatment period and Part B is an open-label period.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290141
Sponsor's protocol ID
EFC18156
Other IDs
U1111-1295-3363, 2023-508338-33, 2023
Acronym
VITALIZE
Status last verified
Oct 2026
First submitted
26 Feb 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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