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New hope for nerve disease patients: drug may replace monthly IV treatments

NCT ID NCT06290141

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 6 times

Summary

This study tests a new drug called riliprubart against standard IVIg treatment in 160 adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a nerve disorder causing weakness and numbness. Participants currently on IVIg will be randomly assigned to receive either riliprubart or continue IVIg to see if the new drug can better control symptoms and maintain improvement over about two years.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jan 2029

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 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee. * Participants must have responded to IVIg in the past 5 years. * Participant must be on a stable maintenance dosage of IVIg. * Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT). * Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines. * Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline. * Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening. * Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention. * Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant * Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive. * Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy. * Sensory CIDP, distal CIDP and focal CIDP variants. * Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments. * Poorly controlled diabetes * Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections). * Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody. * Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening). * Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment. * Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt. * Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse. * Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk. * Recent treatment with plasma exchange * Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive/ chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine). * Prior treatment with riliprubart. * Recent use of any specific complement system inhibitor (eg, eculizumab). * Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation. * Prior treatment with B-cell depleting agents such as rituximab within 6 months. * Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening). * Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening. * Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial. * Positive result of any of the following tests: * hepatitis B surface antigen (HbsAg). * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \[anti-HBs Ab\] are also positive, indicating natural immunity). * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained. * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies. * Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation. * Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized. * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. * Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol. * Recent treatment with efgartigimod. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy

As listed by the trial registrant

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

Chronic inflammatory demyelinating polyneuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    133 sites in 24 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth Orlando- Site Number : 8400006

    RECRUITING

    Orlando, Florida, 32803, United States

  • AdventHealth Site Number : 8400006

    RECRUITING

    Orlando, Florida, 32804-5558, United States

  • Alabama Neurology Associates- Site Number : 8400019

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Austin Neuromuscular Center- Site Number : 8400040

    RECRUITING

    Austin, Texas, 78756, United States

  • Columbia University Irving Medical Center- Site Number : 8400003

    RECRUITING

    New York, New York, 10032, United States

  • Dent Neurologic Institute - Amherst- Site Number : 8400039

    RECRUITING

    Amherst, New York, 14226, United States

  • Design Neuroscience Center- Site Number : 8400053

    RECRUITING

    Miami Lakes, Florida, 33016, United States

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

    RECRUITING

    Belo Horizonte, Minas Gerais, 30150-320, Brazil

  • Gadolin Research - Beaumont- Site Number : 8400047

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Henry Ford Hospital- Site Number : 8400025

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Hospital for Special Surgery - Site Number : 8400041

    RECRUITING

    New York, New York, 10021, United States

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

    RECRUITING

    Centennial, Colorado, 80112, United States

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

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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

    RECRUITING

    Curitiba, Paraná, 81210-310, Brazil

  • Investigational Site Number : 0320001

    RECRUITING

    Buenos Aires, 1015, Argentina

  • Investigational Site Number : 0320002

    RECRUITING

    Buenos Aires, 1181, Argentina

  • Investigational Site Number : 0320003

    RECRUITING

    Buenos Aires, 1221, Argentina

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    COMPLETED

    Ghent, 9000, Belgium

  • Investigational Site Number : 1240001

    RECRUITING

    Québec, Quebec, G1E 7G9, Canada

  • Investigational Site Number : 1240003

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Investigational Site Number : 1240006

    RECRUITING

    Montreal, Quebec, H3a 2b4, Canada

  • Investigational Site Number : 1560001

    RECRUITING

    Shanghai, 200040, China

  • Investigational Site Number : 1560002

    RECRUITING

    Fuzhou, 350001, China

  • Investigational Site Number : 1560003

    RECRUITING

    Wuhan, 430030, China

  • Investigational Site Number : 1560004

    RECRUITING

    Xi'an, 710038, China

  • Investigational Site Number : 1560005

    RECRUITING

    Beijing, 100053, China

  • Investigational Site Number : 1560006

    RECRUITING

    Wuhan, 430060, China

  • Investigational Site Number : 1560007

    RECRUITING

    Guangzhou, 510080, China

  • Investigational Site Number : 1560008

    RECRUITING

    Jinan, 250014, China

  • Investigational Site Number : 1560009

    RECRUITING

    Changsha, 410008, China

  • Investigational Site Number : 1560010

    RECRUITING

    Beijing, 100050, China

  • Investigational Site Number : 1560011

    RECRUITING

    Chengdu, 610072, China

  • Investigational Site Number : 1560012

    RECRUITING

    Guangzhou, 510000, China

  • Investigational Site Number : 1560013

    RECRUITING

    Beijing, 100034, China

  • Investigational Site Number : 1560014

    RECRUITING

    Hangzhou, 310003, China

  • Investigational Site Number : 1560015

    RECRUITING

    Nanchang, 330006, China

  • Investigational Site Number : 1560016

    RECRUITING

    Jiazhuang, 050000, China

  • Investigational Site Number : 1560017

    RECRUITING

    Beijing, 100730, China

  • Investigational Site Number : 1580001

    RECRUITING

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    RECRUITING

    Taipei, 112, Taiwan

  • Investigational Site Number : 1580003

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 2030001

    RECRUITING

    Prague, 128 08, Czechia

  • Investigational Site Number : 2030002

    COMPLETED

    Pardubice, 532 03, Czechia

  • Investigational Site Number : 2030003

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Investigational Site Number : 2030004

    RECRUITING

    Brno, 625 00, Czechia

  • Investigational Site Number : 2030005

    RECRUITING

    Ostrava, 708 52, Czechia

  • Investigational Site Number : 2080001

    RECRUITING

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2080002

    RECRUITING

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2500001

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Investigational Site Number : 2500002

    RECRUITING

    Marseille, 13885, France

  • Investigational Site Number : 2500003

    RECRUITING

    Paris, 75013, France

  • Investigational Site Number : 2500005

    RECRUITING

    Nice, 06001, France

  • Investigational Site Number : 2500006

    RECRUITING

    Lille, 59037, France

  • Investigational Site Number : 2760001

    RECRUITING

    Münster, 48149, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Berlin, 10117, Germany

  • Investigational Site Number : 2760005

    RECRUITING

    Hanover, 30625, Germany

  • Investigational Site Number : 2760006

    RECRUITING

    Göttingen, 37075, Germany

  • Investigational Site Number : 2760007

    RECRUITING

    Essen, 45147, Germany

  • Investigational Site Number : 2760008

    RECRUITING

    Bochum, 44791, Germany

  • Investigational Site Number : 2760009

    RECRUITING

    Homburg, 66421, Germany

  • Investigational Site Number : 2760011

    RECRUITING

    Schwäbisch Hall, 74523, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Athens, 124 62, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Thessaloniki, 546 36, Greece

  • Investigational Site Number : 3480001

    RECRUITING

    Szeged, 6720, Hungary

  • Investigational Site Number : 3480003

    RECRUITING

    Budapest, 1085, Hungary

  • Investigational Site Number : 3480004

    RECRUITING

    Győr, 9024, Hungary

  • Investigational Site Number : 3480005

    RECRUITING

    Budapest, 1125, Hungary

  • Investigational Site Number : 3760001

    RECRUITING

    Haifa, 3109601, Israel

  • Investigational Site Number : 3800001

    RECRUITING

    Padua, Padova, 35128, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Bologna, 40139, Italy

  • Investigational Site Number : 3800003

    RECRUITING

    Milan, Milano, 20133, Italy

  • Investigational Site Number : 3800004

    RECRUITING

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800005

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3920001

    RECRUITING

    Chiba, 260-8677, Japan

  • Investigational Site Number : 3920005

    RECRUITING

    Kawagoe, Saitama, 350-8550, Japan

  • Investigational Site Number : 3920007

    RECRUITING

    Amagasaki, Hyōgo, 660-8511, Japan

  • Investigational Site Number : 3920008

    RECRUITING

    Kodaira, Tokyo, 187-8551, Japan

  • Investigational Site Number : 3920009

    RECRUITING

    Saga, 849-0937, Japan

  • Investigational Site Number : 3920010

    RECRUITING

    Ōta-ku, Tokyo, 143-8541, Japan

  • Investigational Site Number : 3920012

    RECRUITING

    Higashi-Matsuyama, Saitama, 355-0005, Japan

  • Investigational Site Number : 3920014

    RECRUITING

    Yaizu, Shizuoka, 425-8505, Japan

  • Investigational Site Number : 3920015

    RECRUITING

    Yokohama, Kanagawa, 222-0036, Japan

  • Investigational Site Number : 4840001

    RECRUITING

    Tlalnepantla, 54055, Mexico

  • Investigational Site Number : 4840002

    RECRUITING

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 5780001

    RECRUITING

    Oslo, 0450, Norway

  • Investigational Site Number : 6200001

    RECRUITING

    Lisbon, 1349-019, Portugal

  • Investigational Site Number : 6200002

    RECRUITING

    Lisbon, 1150-199, Portugal

  • Investigational Site Number : 6200003

    RECRUITING

    Braga, 4710-243, Portugal

  • Investigational Site Number : 6200005

    RECRUITING

    Coimbra, 3000-075, Portugal

  • Investigational Site Number : 6200006

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Investigational Site Number : 7240001

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240003

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Valencia, 46026, Spain

  • Investigational Site Number : 7240006

    RECRUITING

    Sabadell, Barcelona [Barcelona], 08208, Spain

  • Investigational Site Number : 7240007

    RECRUITING

    Málaga, 29010, Spain

  • Investigational Site Number : 7240008

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7240009

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240010

    RECRUITING

    Santa Cruz de Tenerife, 38010, Spain

  • Investigational Site Number : 7240012

    RECRUITING

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

  • Investigational Site Number : 7520001

    RECRUITING

    Stockholm, 113 65, Sweden

  • Investigational Site Number : 7560001

    RECRUITING

    Basel, 4056, Switzerland

  • Investigational Site Number : 7560003

    RECRUITING

    Bern, 3010, Switzerland

  • Investigational Site Number : 7920001

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    RECRUITING

    Istanbul, 34785, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    RECRUITING

    Konya, 42075, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    RECRUITING

    Bursa, 16059, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Investigational Site Number : 8260003

    RECRUITING

    Inverness, Highland, IV2 3UJ, United Kingdom

  • Investigational Site Number : 8260007

    RECRUITING

    London, England, E1 1BB, United Kingdom

  • Johns Hopkins Hospital- Site Number : 8400015

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Keck School of Medicine of University of Southern California- Site Number : 8400002

    RECRUITING

    Los Angeles, California, 90033, United States

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

    RECRUITING

    Brasília, Federal District, 70200-730, Brazil

  • Lenox Hill Hospital- Site Number : 8400051

    RECRUITING

    New York, New York, 10075, United States

  • Massachusetts General Hospital- Site Number : 8400009

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Michigan State University- Site Number : 8400038

    RECRUITING

    East Lansing, Michigan, 48824, United States

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

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Nova Clinical Research - Bradenton- Site Number : 8400044

    RECRUITING

    Bradenton, Florida, 34209, United States

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

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • PSEG Centro de Pesquisa Clínica- Site Number : 0760009

    RECRUITING

    São Paulo, 04038-002, Brazil

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Profound Research- Site Number : 8400052

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Raleigh Neurology Associates- Site Number : 8400043

    RECRUITING

    Raleigh, North Carolina, 27607, United States

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

    RECRUITING

    Houston, Texas, 77054, United States

  • University Hospitals Cleveland Medical Center- Site Number : 8400033

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California Irvine Medical Center- Site Number : 8400007

    RECRUITING

    Orange, California, 92868, United States

  • University of Cincinnati Medical Center- Site Number : 8400020

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center- Site Number : 8400010

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Vermont Medical Center- Site Number : 8400012

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Virginia- Site Number : 8400023

    RECRUITING

    Charlottesville, Virginia, 22908, United States

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

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine- Site Number : 8400018

    RECRUITING

    New Haven, Connecticut, 06510, United States

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