Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for tough nerve disease: experimental drug riliprubart enters final testing

NCT ID NCT06290128

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests a drug called riliprubart in 140 adults with chronic inflammatory demyelinating polyneuropathy (CIDP) that hasn't improved with standard care. Participants receive either riliprubart or a placebo for up to 111 weeks. The main goal is to see if the drug reduces disability scores at 24 and 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Riliprubart (a drug given by IV infusion or injection under the skin)
What this could lead to
If it works, this could offer a new treatment option for people with CIDP whose disease doesn't improve with current therapies.
What could go wrong
This is still an experimental drug. Even though it's in Phase 3, it may not prove more effective than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

109 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic inflammatory demyelinating polyradiculoneuropathy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune disorder of the nervous system chronic inflammatory demyelinating polyradiculoneuropathy nervous system disorder polyneuropathy, inflammatory demyelinating, chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inflammatory demyelinating polyradiculoneuropathy Polyneuropathy, inflammatory demyelinating, chronic

Contacts and locations

Locations

  • Alabama Neurology Associates- Site Number : 8400019

    Homewood, Alabama, 35209, United States

  • Austin Neuromuscular Center- Site Number : 8400040

    Austin, Texas, 78756, United States

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

    Vitória, Espírito Santo, 29055-450, Brazil

  • Columbia University Irving Medical Center- Site Number : 8400003

    New York, New York, 10032, United States

  • Design Neuroscience Center- Site Number : 8400053

    Miami Lakes, Florida, 33016, United States

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

    Belo Horizonte, Minas Gerais, 30150-320, Brazil

  • Henry Ford Hospital- Site Number : 8400025

    Detroit, Michigan, 48202, United States

  • Hospital Moinhos de Vento- Site Number : 0760003

    Porto Alegre, Rio Grande do Sul, 90035-902, Brazil

  • Hospital Sao Rafael- Site Number : 0760011

    Salvador, Estado de Bahia, 41253-190, Brazil

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

    São Paulo, 05403-000, Brazil

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

    Ribeirão Preto, São Paulo, 14049-900, Brazil

  • Hospital for Special Surgery - Site Number : 8400041

    New York, New York, 10021, United States

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

    Centennial, Colorado, 80112, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1015, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1181, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1221, Argentina

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 1000001

    Pleven, 5800, Bulgaria

  • Investigational Site Number : 1000002

    Blagoevgrad, 2700, Bulgaria

  • Investigational Site Number : 1240001

    Québec, Quebec, G1E 7G9, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8207257, Chile

  • Investigational Site Number : 1520003

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile

  • Investigational Site Number : 1560001

    Shanghai, 200040, China

  • Investigational Site Number : 1560002

    Fuzhou, 350001, China

  • Investigational Site Number : 1560003

    Wuhan, 430030, China

  • Investigational Site Number : 1560004

    Xi'an, 710038, China

  • Investigational Site Number : 1560005

    Beijing, 100053, China

  • Investigational Site Number : 1560006

    Wuhan, 430060, China

  • Investigational Site Number : 1560007

    Guangzhou, 510080, China

  • Investigational Site Number : 1560008

    Jinan, 250014, China

  • Investigational Site Number : 1560009

    Changsha, 410008, China

  • Investigational Site Number : 1560010

    Beijing, 100050, China

  • Investigational Site Number : 1560011

    Chengdu, 610072, China

  • Investigational Site Number : 1560012

    Guangzhou, 510000, China

  • Investigational Site Number : 1560013

    Beijing, 100034, China

  • Investigational Site Number : 1560014

    Hangzhou, 310003, China

  • Investigational Site Number : 1560015

    Nanchang, 330006, China

  • Investigational Site Number : 1560016

    Beijing, 100730, China

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    Taipei, 112, Taiwan

  • Investigational Site Number : 1580003

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 2030002

    Pardubice, 532 03, Czechia

  • Investigational Site Number : 2030003

    Hradec Králové, 500 05, Czechia

  • Investigational Site Number : 2030004

    Brno, 625 00, Czechia

  • Investigational Site Number : 2080001

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2080002

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2500001

    Le Kremlin-Bicêtre, 94270, France

  • Investigational Site Number : 2500002

    Marseille, 13885, France

  • Investigational Site Number : 2500003

    Lille, 59037, France

  • Investigational Site Number : 2500004

    Paris, 75013, France

  • Investigational Site Number : 2500005

    Montpellier, 34295, France

  • Investigational Site Number : 2760001

    Bad Homburg, 61348, Germany

  • Investigational Site Number : 2760003

    Giessen, 35392, Germany

  • Investigational Site Number : 2760004

    Berlin, 12163, Germany

  • Investigational Site Number : 2760005

    Essen, 45147, Germany

  • Investigational Site Number : 2760006

    Tübingen, 72076, Germany

  • Investigational Site Number : 2760007

    Bochum, 44791, Germany

  • Investigational Site Number : 3000001

    Thessaloniki, 546 36, Greece

  • Investigational Site Number : 3000002

    Athens, 124 62, Greece

  • Investigational Site Number : 3000003

    Larissa, 411 10, Greece

  • Investigational Site Number : 3800001

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800003

    Palermo, 90127, Italy

  • Investigational Site Number : 3800004

    Pisa, 56126, Italy

  • Investigational Site Number : 3800005

    Pavia, 27100, Italy

  • Investigational Site Number : 3800006

    Rome, Roma, 00133, Italy

  • Investigational Site Number : 3800007

    Messina, 98125, Italy

  • Investigational Site Number : 3800008

    Rome, Roma, 00189, Italy

  • Investigational Site Number : 3800009

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3920001

    Chiba, 260-8677, Japan

  • Investigational Site Number : 3920003

    Fukuoka, 812-8582, Japan

  • Investigational Site Number : 3920005

    Kawagoe, Saitama, 350-8550, Japan

  • Investigational Site Number : 3920006

    Sayama, Osaka, 589-8511, Japan

  • Investigational Site Number : 3920008

    Kodaira, Tokyo, 187-8551, Japan

  • Investigational Site Number : 3920009

    Saga, 849-0937, Japan

  • Investigational Site Number : 3920011

    Bunkyo-Ku, Tokyo, 113-8510, Japan

  • Investigational Site Number : 3920013

    Tokyo, 173-8605, Japan

  • Investigational Site Number : 3920014

    Yaizu, Shizuoka, 425-8505, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 02841, South Korea

  • Investigational Site Number : 4840002

    Veracruz, 91900, Mexico

  • Investigational Site Number : 4840003

    Guadalajara, Jalisco, 44670, Mexico

  • Investigational Site Number : 4840005

    Culiacán, Sinaloa, 80020, Mexico

  • Investigational Site Number : 5280001

    Amsterdam, 1105 AZ, Netherlands

  • Investigational Site Number : 5280002

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 6160002

    Lublin, Lublin Voivodeship, 20-016, Poland

  • Investigational Site Number : 6160003

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • Investigational Site Number : 6200001

    Lisbon, 1349-019, Portugal

  • Investigational Site Number : 6200003

    Matosinhos Municipality, 4464-513, Portugal

  • Investigational Site Number : 6200004

    Lisbon, 1150-199, Portugal

  • Investigational Site Number : 6200005

    Coimbra, 3000-075, Portugal

  • Investigational Site Number : 6200006

    Lisbon, 1649-035, Portugal

  • Investigational Site Number : 7240001

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Investigational Site Number : 7240002

    Valencia, 46026, Spain

  • Investigational Site Number : 7240003

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240005

    Oviedo, Principality of Asturias, 33011, Spain

  • Investigational Site Number : 7240006

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7240007

    Bilbao, Basque Country, 48013, Spain

  • Investigational Site Number : 7240008

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240009

    Sabadell, 08208, Spain

  • Investigational Site Number : 7240010

    Santa Cruz de Tenerife, 38010, Spain

  • Investigational Site Number : 7240012

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

  • Investigational Site Number : 7520001

    Stockholm, 113 65, Sweden

  • Investigational Site Number : 7920001

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Bursa, 16059, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Konya, 42075, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Istanbul, 34785, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Ankara, 06170, Turkey (Türkiye)

  • Investigational Site Number : 7920007

    Ankara, 06620, Turkey (Türkiye)

  • Johns Hopkins Hospital- Site Number : 8400015

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital- Site Number : 8400009

    Boston, Massachusetts, 02114, United States

  • Michigan State University- Site Number : 8400038

    East Lansing, Michigan, 48824, United States

  • NeuroMedical Clinic of Central Louisiana- Site Number : 8400031

    Alexandria, Louisiana, 71301, United States

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

    Glenview, Illinois, 60026, United States

  • Nova Clinical Research - Bradenton- Site Number : 8400044

    Bradenton, Florida, 34209, United States

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

    New Orleans, Louisiana, 70121, United States

  • PSEG Centro de Pesquisa Clínica- Site Number : 0760009

    São Paulo, 04038-002, Brazil

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

    Philadelphia, Pennsylvania, 19104, United States

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

    Hershey, Pennsylvania, 17033, United States

  • Profound Research- Site Number : 8400052

    Las Vegas, Nevada, 89106, United States

  • Raleigh Neurology Associates- Site Number : 8400043

    Raleigh, North Carolina, 27607, United States

  • USC Norris Comprehensive Cancer Center- Site Number : 8400002

    Los Angeles, California, 90033, United States

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

    Houston, Texas, 77054, United States

  • University Hospitals Cleveland Medical Center- Site Number : 8400033

    Cleveland, Ohio, 44106, United States

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

    Orange, California, 92868, United States

  • University of Cincinnati Medical Center- Site Number : 8400020

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center- Site Number : 8400010

    Kansas City, Kansas, 66160, United States

  • University of Vermont Medical Center- Site Number : 8400012

    Burlington, Vermont, 05401, United States

  • University of Virginia- Site Number : 8400023

    Charlottesville, Virginia, 22908, United States

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

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine- Site Number : 8400018

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.