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AzTrials

Chronic Inflammatory Demyelinating PolyradiculoneuropathyPhase 3MOBILIZENCT06290128

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

A Phase 3 study testing Riliprubart in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Polyneuropathy, Inflammatory Demyelinating, Chronic, run by Sanofi at 132 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Riliprubart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
132 sitesin 24 countries
Study dates
12 Jul 2024to 31 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 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
Show all 13Show fewer
  • 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

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 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)
Show all 35Show fewer
  • 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.

Trial locations and contacts

132 sites in 24 countries.

132 sites in 24 countries

United States28 sites

  • NeuroMedical Clinic of Central Louisiana- Site Number : 8400031

    Alexandria, Louisiana, 71301

  • Austin Neuromuscular Center- Site Number : 8400040

    Austin, Texas, 78756

  • Johns Hopkins Hospital- Site Number : 8400015

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital- Site Number : 8400009

    Boston, Massachusetts, 02114

  • Nova Clinical Research - Bradenton- Site Number : 8400044

    Bradenton, Florida, 34209

  • University of Vermont Medical Center- Site Number : 8400012

    Burlington, Vermont, 05401

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

    Centennial, Colorado, 80112

  • University of Virginia- Site Number : 8400023

    Charlottesville, Virginia, 22908

  • University of Cincinnati Medical Center- Site Number : 8400020

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center- Site Number : 8400033

    Cleveland, Ohio, 44106

  • Henry Ford Hospital- Site Number : 8400025

    Detroit, Michigan, 48202

  • Michigan State University- Site Number : 8400038

    East Lansing, Michigan, 48824

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

    Glenview, Illinois, 60026

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

    Hershey, Pennsylvania, 17033

  • Alabama Neurology Associates- Site Number : 8400019

    Homewood, Alabama, 35209

  • UTHealth - The University of Texas Health Sciences Center at Houston- Site Number : 8400050

    Houston, Texas, 77054

  • University of Kansas Medical Center- Site Number : 8400010

    Kansas City, Kansas, 66160

  • Profound Research- Site Number : 8400052

    Las Vegas, Nevada, 89106

  • USC Norris Comprehensive Cancer Center- Site Number : 8400002

    Los Angeles, California, 90033

  • Design Neuroscience Center- Site Number : 8400053

    Miami Lakes, Florida, 33016

  • Yale University School of Medicine- Site Number : 8400018

    New Haven, Connecticut, 06510

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

    New Orleans, Louisiana, 70121

  • Hospital for Special Surgery - Site Number : 8400041

    New York, New York, 10021

  • Columbia University Irving Medical Center- Site Number : 8400003

    New York, New York, 10032

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

    Orange, California, 92868

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

    Philadelphia, Pennsylvania, 19104

  • Raleigh Neurology Associates- Site Number : 8400043

    Raleigh, North Carolina, 27607

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

    St Louis, Missouri, 63110

Other trials in United States

China16 sites

  • Investigational Site Number : 1560013

    Beijing, 100034

  • Investigational Site Number : 1560010

    Beijing, 100050

  • Investigational Site Number : 1560005

    Beijing, 100053

  • Investigational Site Number : 1560016

    Beijing, 100730

  • Investigational Site Number : 1560009

    Changsha, 410008

  • Investigational Site Number : 1560011

    Chengdu, 610072

  • Investigational Site Number : 1560002

    Fuzhou, 350001

  • Investigational Site Number : 1560012

    Guangzhou, 510000

  • Investigational Site Number : 1560007

    Guangzhou, 510080

  • Investigational Site Number : 1560014

    Hangzhou, 310003

  • Investigational Site Number : 1560008

    Jinan, 250014

  • Investigational Site Number : 1560015

    Nanchang, 330006

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560003

    Wuhan, 430030

  • Investigational Site Number : 1560006

    Wuhan, 430060

  • Investigational Site Number : 1560004

    Xi'an, 710038

Other trials in China

Spain10 sites

  • Investigational Site Number : 7240008

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240001

    Barcelona, Catalunya [Cataluña], 08041

  • Investigational Site Number : 7240007

    Bilbao, Basque Country, 48013

  • Investigational Site Number : 7240006

    Majadahonda, Madrid, 28222

  • Investigational Site Number : 7240005

    Oviedo, Principality of Asturias, 33011

  • Investigational Site Number : 7240003

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240009

    Sabadell, 08208

  • Investigational Site Number : 7240010

    Santa Cruz de Tenerife, 38010

  • Investigational Site Number : 7240012

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

  • Investigational Site Number : 7240002

    Valencia, 46026

Other trials in Spain

Japan9 sites

  • Investigational Site Number : 3920011

    Bunkyo-Ku, Tokyo, 113-8510

  • Investigational Site Number : 3920001

    Chiba, 260-8677

  • Investigational Site Number : 3920003

    Fukuoka, 812-8582

  • Investigational Site Number : 3920005

    Kawagoe, Saitama, 350-8550

  • Investigational Site Number : 3920008

    Kodaira, Tokyo, 187-8551

  • Investigational Site Number : 3920009

    Saga, 849-0937

  • Investigational Site Number : 3920006

    Sayama, Osaka, 589-8511

  • Investigational Site Number : 3920013

    Tokyo, 173-8605

  • Investigational Site Number : 3920014

    Yaizu, Shizuoka, 425-8505

Other trials in Japan

Italy8 sites

  • Investigational Site Number : 3800007

    Messina, 98125

  • Investigational Site Number : 3800001

    Milan, Milano, 20132

  • Investigational Site Number : 3800003

    Palermo, 90127

  • Investigational Site Number : 3800005

    Pavia, 27100

  • Investigational Site Number : 3800004

    Pisa, 56126

  • Investigational Site Number : 3800006

    Rome, Roma, 00133

  • Investigational Site Number : 3800008

    Rome, Roma, 00189

  • Investigational Site Number : 3800009

    Rozzano, Milano, 20089

Other trials in Italy

Brazil7 sites

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

    Belo Horizonte, Minas Gerais, 30150-320

  • Hospital Moinhos de Vento- Site Number : 0760003

    Porto Alegre, Rio Grande do Sul, 90035-902

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

    Ribeirão Preto, São Paulo, 14049-900

  • Hospital Sao Rafael- Site Number : 0760011

    Salvador, Estado de Bahia, 41253-190

  • PSEG Centro de Pesquisa Clínica- Site Number : 0760009

    São Paulo, 04038-002

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760017

    São Paulo, 05403-000

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

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Germany6 sites

  • Investigational Site Number : 2760001

    Bad Homburg, 61348

  • Investigational Site Number : 2760004

    Berlin, 12163

  • Investigational Site Number : 2760007

    Bochum, 44791

  • Investigational Site Number : 2760005

    Essen, 45147

  • Investigational Site Number : 2760003

    Giessen, 35392

  • Investigational Site Number : 2760006

    Tübingen, 72076

Other trials in Germany

Turkey (Türkiye)6 sites

  • Investigational Site Number : 7920006

    Ankara, 06170

  • Investigational Site Number : 7920007

    Ankara, 06620

  • Investigational Site Number : 7920002

    Bursa, 16059

  • Investigational Site Number : 7920001

    Istanbul, 34093

  • Investigational Site Number : 7920004

    Istanbul, 34785

  • Investigational Site Number : 7920003

    Konya, 42075

Other trials in Turkey (Türkiye)

France5 sites

  • Investigational Site Number : 2500001

    Le Kremlin-Bicêtre, 94270

  • Investigational Site Number : 2500003

    Lille, 59037

  • Investigational Site Number : 2500002

    Marseille, 13885

  • Investigational Site Number : 2500005

    Montpellier, 34295

  • Investigational Site Number : 2500004

    Paris, 75013

Other trials in France

Portugal5 sites

  • Investigational Site Number : 6200005

    Coimbra, 3000-075

  • Investigational Site Number : 6200004

    Lisbon, 1150-199

  • Investigational Site Number : 6200001

    Lisbon, 1349-019

  • Investigational Site Number : 6200006

    Lisbon, 1649-035

  • Investigational Site Number : 6200003

    Matosinhos Municipality, 4464-513

Other trials in Portugal

Argentina3 sites

  • Investigational Site Number : 0320001

    Buenos Aires, 1015

  • Investigational Site Number : 0320002

    Buenos Aires, 1181

  • Investigational Site Number : 0320003

    Buenos Aires, 1221

Other trials in Argentina

Chile3 sites

  • Investigational Site Number : 1520003

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8207257

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8380456

Other trials in Chile

Czechia3 sites

  • Investigational Site Number : 2030004

    Brno, 625 00

  • Investigational Site Number : 2030003

    Hradec Králové, 500 05

  • Investigational Site Number : 2030002

    Pardubice, 532 03

Other trials in Czechia

Greece3 sites

  • Investigational Site Number : 3000002

    Athens, 124 62

  • Investigational Site Number : 3000003

    Larissa, 411 10

  • Investigational Site Number : 3000001

    Thessaloniki, 546 36

Other trials in Greece

Mexico3 sites

  • Investigational Site Number : 4840005

    Culiacán, Sinaloa, 80020

  • Investigational Site Number : 4840003

    Guadalajara, Jalisco, 44670

  • Investigational Site Number : 4840002

    Veracruz, 91900

Other trials in Mexico

Poland3 sites

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-501

  • Investigational Site Number : 6160002

    Lublin, Lublin Voivodeship, 20-016

  • Investigational Site Number : 6160003

    Rzeszów, Podkarpackie Voivodeship, 35-055

Other trials in Poland

Taiwan3 sites

  • Investigational Site Number : 1580003

    Kaohsiung City, 833

  • Investigational Site Number : 1580001

    Taipei, 100

  • Investigational Site Number : 1580002

    Taipei, 112

Other trials in Taiwan

Bulgaria2 sites

  • Investigational Site Number : 1000002

    Blagoevgrad, 2700

  • Investigational Site Number : 1000001

    Pleven, 5800

Other trials in Bulgaria

Denmark2 sites

  • Investigational Site Number : 2080002

    Aarhus, 8200

  • Investigational Site Number : 2080001

    Copenhagen, 2100

Other trials in Denmark

Netherlands2 sites

  • Investigational Site Number : 5280001

    Amsterdam, 1105 AZ

  • Investigational Site Number : 5280002

    Rotterdam, 3015 CE

Other trials in Netherlands

South Korea2 sites

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 02841

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06351

Other trials in South Korea

Belgium1 site

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

Canada1 site

  • Investigational Site Number : 1240001

    Québec, Quebec, G1E 7G9

Other trials in Canada

Sweden1 site

  • Investigational Site Number : 7520001

    Stockholm, 113 65

Other trials in Sweden

About this study

Official title: 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.

Being tested
Riliprubart, Placebo
Keywords
Autoimmune Diseases, Neurologic, Autoimmune Disorders, Nervous System, Peripheral Nerves Disease, Nervous System Diseases, Neurologic Disorders, Neurological Disorders, Complement Inhibitor, Complement Inhibitors
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Autoimmune Diseases of the Nervous System, Nervous System Diseases

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 Infusion

  • PlaceboDrug

    Pharmaceutical form: Solution Route of administration: IV Infusion

  • RiliprubartDrug

    Also called SAR445088

    Pharmaceutical form: Solution Route of administration: SC Injection

  • PlaceboDrug

    Pharmaceutical form: Solution Route of administration: SC Injection

Study groups in NCT06290128
Study groupRoleWhat they receive
Riliprubart ArmExperimentalRiliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Receives: Drug: Riliprubart; Drug: Placebo
Placebo ArmPlacebo comparatorPlacebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Receives: Drug: Riliprubart; Drug: Placebo

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 a 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 with lasting response

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

    Measured: Baseline to week 48

  3. 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.

    Measured: Week 24 to week 48

Secondary outcomes (18)

  1. Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) 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. 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

    Measured: Baseline to week 24

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

    Measured: Baseline to week 24

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

    Measured: Baseline to week 24

  8. Number of participants with treatment emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A

    Measured: Baseline to week 24

  9. Incidence and titer of anti-riliprubart antibodies (ADA)

    Measured: Baseline to week 24

  10. Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B

    Measured: Week 24 to week 103

  11. Incidence and titer of anti-riliprubart antibodies

    Measured: Week 24 to week 103

  12. Change from baseline in I RODS score

    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. Change from baseline in RT-FSS

    Measured: Baseline to week 48

  18. 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.

    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 start12 Jul 2024
  3. Primary completion10 Jun 2026
  4. Study completion31 Oct 2027 (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
This is a double-blind treatment in part A and open-label treatment in Part B.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290128
Sponsor's protocol ID
EFC17236
Other IDs
U1111-1295-5755, 2023-506503-26, 2023
Acronym
MOBILIZE
Status last verified
Aug 2026
First submitted
26 Feb 2024
Last updated
10 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Riliprubart in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Polyneuropathy, Inflammatory Demyelinating, Chronic, run by Sanofi at 132 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, China, Spain, Japan, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants experiencing a response (time frame: Baseline to week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06290128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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