Recruiting
Phase 3

Riliprubart vs. IVIg

Sponsor:

Sanofi

Code:

NCT06290141

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

riliprubart

Placebo

riliprubart

Placebo

IVIg

Study Details

Brief summary:

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Study ID

NCT06290141

Start date

Aug 21, 2024

Status verified date

Aug, 2026

Completion date

Jan 12, 2029

Anticipated

Primary completion date

Jul 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Riliprubart Arm

Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

active comparator: IVIg Arm

IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

Interventions

riliprubart

Pharmaceutical form: Solution Route of administration: IV solution

Placebo

Pharmaceutical form: Solution Route of administration: IV solution

riliprubart

Pharmaceutical form: Solution Route of administration: SC solution

Placebo

Pharmaceutical form: Solution Route of administration: SC solution

IVIg

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

Placebo

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

Primary outcome measure

  • Percentage of participants experiencing a response [ Time Frame: Baseline to week 24 ]
  • Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period [ Time Frame: Baseline to week 48 ]

Central Contacts and Locations

Central contacts

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

800-633-1610contact-us@sanofi.com

Locations

Alabama Neurology Associates- Site Number : 8400019

Recruiting

Homewood, Alabama, United States, 35209

Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014

Recruiting

Scottsdale, Arizona, United States, 85251

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

Recruiting

Los Angeles, California, United States, 90033

University of California Irvine Medical Center- Site Number : 8400007

Recruiting

Orange, California, United States, 92868

IMMUNOe International Research Centers - Centennial- Site Number : 8400049

Recruiting

Centennial, Colorado, United States, 80112

Yale University School of Medicine- Site Number : 8400018

Recruiting

New Haven, Connecticut, United States, 06510

Nova Clinical Research - Bradenton- Site Number : 8400044

Recruiting

Bradenton, Florida, United States, 34209

Design Neuroscience Center- Site Number : 8400053

Recruiting

Miami Lakes, Florida, United States, 33016

AdventHealth Orlando- Site Number : 8400006

Recruiting

Orlando, Florida, United States, 32803

AdventHealth Site Number : 8400006

Recruiting

Orlando, Florida, United States, 32804-5558

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

Recruiting

Glenview, Illinois, United States, 60026

University of Kansas Medical Center- Site Number : 8400010

Recruiting

Kansas City, Kansas, United States, 66160

Ochsner Medical Center - Jefferson Highway- Site Number : 8400030

Recruiting

New Orleans, Louisiana, United States, 70121

Johns Hopkins Hospital- Site Number : 8400015

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts General Hospital- Site Number : 8400009

Recruiting

Boston, Massachusetts, United States, 02114

Henry Ford Hospital- Site Number : 8400025

Recruiting

Detroit, Michigan, United States, 48202

Michigan State University- Site Number : 8400038

Recruiting

East Lansing, Michigan, United States, 48824

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

Recruiting

St Louis, Missouri, United States, 63110

Profound Research- Site Number : 8400052

Recruiting

Las Vegas, Nevada, United States, 89106

Dent Neurologic Institute - Amherst- Site Number : 8400039

Recruiting

Amherst, New York, United States, 14226

Hospital for Special Surgery - Site Number : 8400041

Recruiting

New York, New York, United States, 10021

Columbia University Irving Medical Center- Site Number : 8400003

Recruiting

New York, New York, United States, 10032

Lenox Hill Hospital- Site Number : 8400051

Recruiting

New York, New York, United States, 10075

Raleigh Neurology Associates- Site Number : 8400043

Recruiting

Raleigh, North Carolina, United States, 27607

University of Cincinnati Medical Center- Site Number : 8400020

Recruiting

Cincinnati, Ohio, United States, 45219

University Hospitals Cleveland Medical Center- Site Number : 8400033

Recruiting

Cleveland, Ohio, United States, 44106

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

Recruiting

Hershey, Pennsylvania, United States, 17033

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Austin Neuromuscular Center- Site Number : 8400040

Recruiting

Austin, Texas, United States, 78756

Gadolin Research - Beaumont- Site Number : 8400047

Recruiting

Beaumont, Texas, United States, 77702

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

Recruiting

Houston, Texas, United States, 77054

University of Vermont Medical Center- Site Number : 8400012

Recruiting

Burlington, Vermont, United States, 05401

University of Virginia- Site Number : 8400023

Recruiting

Charlottesville, Virginia, United States, 22908

Investigational Site Number : 1240003

Recruiting

London, Ontario, Canada, N6A 5A5

Investigational Site Number : 1240006

Recruiting

Montreal, Quebec, Canada, H3a 2b4

Investigational Site Number : 1240001

Recruiting

Québec, Quebec, Canada, G1E 7G9

More Information

Sponsor

Sanofi

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-08-26.