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 (MOBILIZE)

A Phase 3, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Riliprubart in Participants With Refractory Chronic Inflammatory Demyelinating Polyneuropathy

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Polyneuropathy, Inflammatory Demyelinating, Chronic
• Intervention / Treatment: Drug: Riliprubart; Drug: Placebo; Drug: Riliprubart; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• 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
  • Leuven, Belgium, 3000
    • Recruiting
    • Investigational Site Number : 0560001
• Brazil
  • São Paulo, Brazil, 04038-002
    • Recruiting
    • PSEG Centro de Pesquisa Clínica- Site Number : 0760009
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055-450
      • Recruiting
      • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760012
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Recruiting
      • Hospital Sao Rafael- Site Number : 0760011
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
      • Recruiting
      • Hospital Moinhos de Vento- Site Number : 0760003
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • Recruiting
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760007
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Recruiting
    • Investigational Site Number : 1000002
  • Pleven, Bulgaria, 5800
    • Recruiting
    • Investigational Site Number : 1000001
• Canada
  • Quebec
    • Québec, Quebec, Canada, G1E 7G9
      • Recruiting
      • Investigational Site Number : 1240001
• Chile
  • Reg Metropolitana de Santiago
    • Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
      • Recruiting
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 8207257
      • Recruiting
      • Investigational Site Number : 1520002
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380456
      • Recruiting
      • Investigational Site Number : 1520001
• 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 : 1560016
  • 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
  • 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
  • Pardubice, Czechia, 532 03
    • Completed
    • Investigational Site Number : 2030002
• 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
  • Lille, France, 59037
    • Recruiting
    • Investigational Site Number : 2500003
  • Marseille, France, 13885
    • Recruiting
    • Investigational Site Number : 2500002
  • Montpellier, France, 34295
    • Recruiting
    • Investigational Site Number : 2500005
  • Paris, France, 75013
    • Recruiting
    • Investigational Site Number : 2500004
• Germany
  • Bad Homburg, Germany, 61348
    • Recruiting
    • Investigational Site Number : 2760001
  • Berlin, Germany, 12163
    • Recruiting
    • Investigational Site Number : 2760004
  • Bochum, Germany, 44791
    • Recruiting
    • Investigational Site Number : 2760007
  • Essen, Germany, 45147
    • Recruiting
    • Investigational Site Number : 2760005
  • Giessen, Germany, 35392
    • Recruiting
    • Investigational Site Number : 2760003
  • Tübingen, Germany, 72076
    • Recruiting
    • Investigational Site Number : 2760006
• Greece
  • Athens, Greece, 124 62
    • Recruiting
    • Investigational Site Number : 3000002
  • Larissa, Greece, 411 10
    • Recruiting
    • Investigational Site Number : 3000003
  • Thessaloniki, Greece, 546 36
    • Recruiting
    • Investigational Site Number : 3000001
• Italy
  • Messina, Italy, 98125
    • Recruiting
    • Investigational Site Number : 3800007
  • Palermo, Italy, 90127
    • Recruiting
    • Investigational Site Number : 3800003
  • Pavia, Italy, 27100
    • Recruiting
    • Investigational Site Number : 3800005
  • Pisa, Italy, 56126
    • Recruiting
    • Investigational Site Number : 3800004
  • Milano
    • Milan, Milano, Italy, 20132
      • Recruiting
      • Investigational Site Number : 3800001
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Investigational Site Number : 3800009
  • Roma
    • Rome, Roma, Italy, 00133
      • Recruiting
      • Investigational Site Number : 3800006
    • Rome, Roma, Italy, 00189
      • Recruiting
      • Investigational Site Number : 3800008
• Japan
  • Chiba, Japan, 260-8677
    • Recruiting
    • Investigational Site Number : 3920001
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Investigational Site Number : 3920003
  • Saga, Japan, 849-0937
    • Recruiting
    • Investigational Site Number : 3920009
  • Tokyo, Japan, 173-8605
    • Recruiting
    • Investigational Site Number : 3920013
  • Osaka
    • Sayama, Osaka, Japan, 589-8511
      • Recruiting
      • Investigational Site Number : 3920006
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Recruiting
      • Investigational Site Number : 3920005
  • Shizuoka
    • Yaizu, Shizuoka, Japan, 425-8505
      • Recruiting
      • Investigational Site Number : 3920014
  • Tokyo
    • Bunkyo, Tokyo, Japan, 113-8510
      • Recruiting
      • Investigational Site Number : 3920011
    • Kodaira, Tokyo, Japan, 187-8551
      • Recruiting
      • Investigational Site Number : 3920008
• Mexico
  • Veracruz, Mexico, 91900
    • Recruiting
    • Investigational Site Number : 4840002
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Recruiting
      • Investigational Site Number : 4840003
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Recruiting
      • Investigational Site Number : 4840005
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Investigational Site Number : 5280001
  • Rotterdam, Netherlands, 3015 CE
    • Recruiting
    • Investigational Site Number : 5280002
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-501
      • Recruiting
      • Investigational Site Number : 6160006
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-016
      • Recruiting
      • Investigational Site Number : 6160002
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Recruiting
      • Investigational Site Number : 6160003
• Portugal
  • 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 : 6200004
  • Matosinhos Municipality, Portugal, 4464-513
    • Recruiting
    • Investigational Site Number : 6200003
• South Korea
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 02841
      • Recruiting
      • Investigational Site Number : 4100003
    • Seoul, Seoul-teukbyeolsi, South Korea, 05505
      • Recruiting
      • Investigational Site Number : 4100002
    • Seoul, Seoul-teukbyeolsi, South Korea, 06351
      • Recruiting
      • Investigational Site Number : 4100001
• Spain
  • Sabadell, Spain, 08208
    • Recruiting
    • Investigational Site Number : 7240009
  • Santa Cruz de Tenerife, Spain, 38010
    • Recruiting
    • Investigational Site Number : 7240010
  • Valencia, Spain, 46026
    • Recruiting
    • Investigational Site Number : 7240002
  • 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 : 7240008
  • Basque Country
    • Bilbao, Basque Country, Spain, 48013
      • Recruiting
      • Investigational Site Number : 7240007
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08041
      • Recruiting
      • Investigational Site Number : 7240001
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Investigational Site Number : 7240006
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Investigational Site Number : 7240003
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Recruiting
      • Investigational Site Number : 7240005
• Sweden
  • Stockholm, Sweden, 113 65
    • Recruiting
    • Investigational Site Number : 7520001
• 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)
  • Ankara, Turkey (Türkiye), 06170
    • Recruiting
    • Investigational Site Number : 7920006
  • Bursa, Turkey (Türkiye), 16059
    • Recruiting
    • Investigational Site Number : 7920002
  • Istanbul, Turkey (Türkiye), 34785
    • Recruiting
    • Investigational Site Number : 7920004
  • Istanbul, Turkey (Türkiye), 34093
    • Recruiting
    • Investigational Site Number : 7920001
  • Konya, Turkey (Türkiye), 42075
    • Recruiting
    • Investigational Site Number : 7920003
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Recruiting
      • Alabama Neurology Associates- Site Number : 8400019
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Norris Comprehensive Cancer Center- Site Number : 8400002
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine - Manchester Pavilion- Site Number : 8400007
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Recruiting
      • IMMUNOe International Research Centers - Centennial- Site Number : 8400049
  • 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
  • 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
    • Alexandria, Louisiana, United States, 71301
      • Recruiting
      • NeuroMedical Clinic of Central Louisiana- Site Number : 8400031
    • 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
    • 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

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 two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.

• Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.

  • Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening
  • Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening
• Participant has an INCAT score of 2 to 9
• Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months
• Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone or equivalent)
• Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening
• Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention
• Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant
• A body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Polyneuropathy of other causes, including but not limited to: acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to Immunoglobulin M (IgM) monoclonal gammopathy, POEMS syndrome, and lumbosacral radiculoplexus neuropathy.
• Sensory CIDP, Distal CIDP and focal CIDP variants.
• Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments
• Poorly controlled diabetes
• Serious infections requiring hospitalization within 30 days prior to Screening and any active infection requiring antimicrobial treatment during screening or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections)
• Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti-double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
• Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per Investigator's judgment.
• Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on C-SSRS during screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.
• Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse
• Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk
• Participant has recently received immunoglobulins (IVIg or SCIg)
• Recent treatment with plasma exchange
• Prior treatment with riliprubart
• Prior treatment with (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine
• Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation
• Prior treatment with B-cell-depleting agents such as rituximab within 6 months
• Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer
• Treatment within 6 months prior to dosing with immunosuppressive/ chemotherapeutic medications, such as cyclophosphamide, methotrexate, tacrolimus, interferon, or tumor necrosis factor (TNF)-α inhibitors. Certain immunosuppressants commonly used in CIDP (azathioprine, cyclosporine, or mycophenolate mofetil) are allowed, as indicated under inclusion criterion.
• Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening)
• Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening
• Any screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial

• Positive result of any of the following tests:

  • Hepatitis B surface antigen (HBsAg).
  • Anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies [anti-HBs Ab] are also positive, indicating natural immunity).
  • Anti-hepatitis C virus (anti-HCV) antibodies (participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained).
  • Anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.
• Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
• Accommodation in an institution because of regulatory or legal order; eg, imprisoned or legally institutionalized
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potential risk for noncompliance to study procedures
• Participants are employees at the clinical study site or other individuals directly involved in the conduct of the study, or immediate family member of such individuals
• Any country related specific regulation that would prevent the participant from entering the study
• Recent treatment with efgartigimod

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Riliprubart Arm; Riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks	Drug: Riliprubart; Pharmaceutical form: Solution Route of administration: IV Infusion; Other Names: SAR445088; Drug: Placebo; Pharmaceutical form: Solution Route of administration: IV Infusion; Drug: Riliprubart; Pharmaceutical form: Solution Route of administration: SC Injection; Other Names: SAR445088; Drug: Placebo; Pharmaceutical form: Solution Route of administration: SC Injection
Placebo Comparator: Placebo Arm; Placebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks	Drug: Riliprubart; Pharmaceutical form: Solution Route of administration: IV Infusion; Other Names: SAR445088; Drug: Placebo; Pharmaceutical form: Solution Route of administration: IV Infusion; Drug: Riliprubart; Pharmaceutical form: Solution Route of administration: SC Injection; Other Names: SAR445088; Drug: Placebo; Pharmaceutical form: Solution Route of administration: SC Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of participants refractory to immunoglobulins 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
Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)		Baseline to week 24
Incidence and titer of anti-riliprubart antibodies (ADA)		Baseline to week 24
Change from baseline in I RODS score		Baseline to week 48
Change from baseline in adjusted INCAT score		Baseline to week 48
Change from baseline in grip strength (kilopascals; dominant hand)		Baseline to week 48
Change from baseline in MRC-SS		Baseline to week 48
Change from baseline in EQ-5D-5L score		Baseline to week 48
Change from baseline in RT-FSS		Baseline to week 48
Change from baseline in Medical Research Council Sum Score (MRC-SS)		Baseline to week 24
Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)		Baseline to week 24
Number of participants with treatment emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A		Baseline to week 24
Percentage of participants randomized to riliprubart who experience a response at Week 48 without prior response in Part A (delayed response)	A delayed response is defined as a decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus baseline.	Baseline to week 48
Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B		Week 24 to week 103
Incidence and titer of anti-riliprubart antibodies		Week 24 to week 103

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): November 20, 2028

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 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Neurological Disorders; Complement Inhibitor; Neurologic Disorders; Autoimmune Diseases, Neurologic; Autoimmune Disorders, Nervous System; Peripheral Nerves Disease; Complement Inhibitors
• Additional Relevant MeSH Terms: Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Autoimmune Diseases of the Nervous System; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: EFC17236; U1111-1295-5755 (Registry Identifier: ICTRP); 2023-506503-26 (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