A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT ID: NCT06290141
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2024-08-21
2029-01-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
NCT06859099
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT06920004
Ripertamab for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
NCT06858722
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT05327114
Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT06325943
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Riliprubart Arm
Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
riliprubart
Pharmaceutical form: Solution Route of administration: IV solution
riliprubart
Pharmaceutical form: Solution Route of administration: SC solution
Placebo
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
IVIg Arm
IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripherial Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).
2. Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.
3. Participants must have responded to IVIg in the past 5 years. Response must be an objective clinically meaningful improvement defined by at least one of the following: ≥1 point decrease in adjusted INCAT score, ≥4 points increase in I-RODS centile score, ≥3 points increase in the MRC-SS, ≥8 kilopascal improvement in mean grip strength (1 hand), or an equivalent improvement based on information documented in medical records as per the Investigator's judgment.
4. Participant must be on a stable maintenance dosage of IVIg, defined as no change greater than 10% in frequency or dose of IVIg within 8 weeks prior to Screening, and remaining stable until baseline.
5. 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).
6. Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines: 0.4 to 1 g/kg every 2 to 6 weeks. The IVIg maintenance dosing regimen should be equivalent or higher than a weekly dose of 0.1 g/kg body weight (for example, 0.3 g/kg every 3 weeks).
7. 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.
8. Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.
9. 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.
10. All participants must agree to use contraception methods during and after the study as required.
11. Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
12. A male participant is eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication.
--Refrain from donating or cryopreserving sperm.
PLUS, either:
--Be abstinent from heterosexual intercourse (abstinent on a long-term and persistent basis) and agree to remain abstinent.
OR
--Must agree to use contraception/barrier as detailed below:
13. A male condom and an additional highly effective contraceptive method (Contraceptive and barrier guidance per protocol) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
14. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a woman of nonchildbearing potential (WONCBP) as defined by the protocol. OR
* Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), as described in the protocol during the study intervention period (to be effective before starting the intervention) and for at least 55 weeks after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
15. Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.
16. 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
1. 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.
2. Sensory CIDP, distal CIDP and focal CIDP variants.
3. Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.
4. Poorly controlled diabetes (HbA1c glycated hemoglobin \>7% at the Screening visit).
5. Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring 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).
6. 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.
7. 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.
8. 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).
9. 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.
10. 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.
11. Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.
12. Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.
13. Treatment with plasma exchange within 8 weeks prior to Screening.
14. Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (except ≤20 mg/day of prednisone or equivalent which is allowed), or prior treatment (at any time) with highly immunosuppressive/ chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).
15. Prior treatment with riliprubart.
16. Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening.
17. Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.
18. Prior treatment with B-cell depleting agents such as rituximab within 6 months prior to riliprubart dosing, or until return of B-cell counts to normal levels, whichever is longer.
19. Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).
20. 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.
21. 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.
22. Positive result of any of the following tests:
* HBsAg
* Anti-HBc; unless anti-HBs Ab X are also positive, indicating natural immunity.
* Anti-HCV antibodies.
* Anti-HIV1 and anti-HIV2 antibodies.
23. Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.
24. Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.
25. 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.
26. 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.
27. Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.
28. Treatment with efgartigimod within 8 weeks prior to screening.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
Scottsdale, Arizona, United States
Keck School of Medicine of University of Southern California- Site Number : 8400002
Los Angeles, California, United States
University of California Irvine Medical Center- Site Number : 8400007
Orange, California, United States
Yale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States
AdventHealth Orlando- Site Number : 8400006
Orlando, Florida, United States
AdventHealth Site Number : 8400006
Orlando, Florida, United States
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States
University of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans, Louisiana, United States
Johns Hopkins Hospital- Site Number : 8400015
Baltimore, Maryland, United States
Massachusetts General Hospital- Site Number : 8400009
Boston, Massachusetts, United States
Henry Ford Hospital- Site Number : 8400025
Detroit, Michigan, United States
Michigan State University- Site Number : 8400038
East Lansing, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
St Louis, Missouri, United States
Dent Neurologic Institute - Amherst- Site Number : 8400039
Amherst, New York, United States
Hospital for Special Surgery- Site Number : 8400041
New York, New York, United States
Columbia University Irving Medical Center- Site Number : 8400003
New York, New York, United States
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland, Ohio, United States
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, United States
Austin Neuromuscular Center- Site Number : 8400040
Austin, Texas, United States
University of Vermont Medical Center- Site Number : 8400012
Burlington, Vermont, United States
University of Virginia- Site Number : 8400023
Charlottesville, Virginia, United States
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0560002
Ghent, , Belgium
Investigational Site Number : 0560001
Leuven, , Belgium
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
Brasília, Federal District, Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
Curitiba, Paraná, Brazil
InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, , Brazil
Investigational Site Number : 1240003
London, Ontario, Canada
Investigational Site Number : 1240006
Montreal, Quebec, Canada
Investigational Site Number : 1240001
Québec, Quebec, Canada
Investigational Site Number : 1560013
Beijing, , China
Investigational Site Number : 1560010
Beijing, , China
Investigational Site Number : 1560005
Beijing, , China
Investigational Site Number : 1560009
Changsha, , China
Investigational Site Number : 1560011
Chengdu, , China
Investigational Site Number : 1560002
Fuzhou, , China
Investigational Site Number : 1560012
Guangzhou, , China
Investigational Site Number : 1560007
Guangzhou, , China
Investigational Site Number : 1560014
Hangzhou, , China
Investigational Site Number : 1560016
Jiazhuang, , China
Investigational Site Number : 1560008
Jinan, , China
Investigational Site Number : 1560015
Nanchang, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560003
Wuhan, , China
Investigational Site Number : 1560006
Wuhan, , China
Investigational Site Number : 1560004
Xi'an, , China
Investigational Site Number : 2030004
Brno, , Czechia
Investigational Site Number : 2030003
Hradec Králové, , Czechia
Investigational Site Number : 2030005
Ostrava, , Czechia
Investigational Site Number : 2030002
Pardubice, , Czechia
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 2080002
Aarhus, , Denmark
Investigational Site Number : 2080001
Copenhagen, , Denmark
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, , France
Investigational Site Number : 2500002
Marseille, , France
Investigational Site Number : 2500005
Nice, , France
Investigational Site Number : 2500003
Paris, , France
Investigational Site Number : 2760003
Berlin, , Germany
Investigational Site Number : 2760006
Göttingen, , Germany
Investigational Site Number : 2760005
Hanover, , Germany
Investigational Site Number : 2760001
Münster, , Germany
Investigational Site Number : 3480003
Budapest, , Hungary
Investigational Site Number : 3480004
Győr, , Hungary
Investigational Site Number : 3480001
Szeged, , Hungary
Investigational Site Number : 3760001
Haifa, , Israel
Investigational Site Number : 3920007
Amagasaki, Hyōgo, Japan
Investigational Site Number : 3920015
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920012
Higashimatsuyama-shi, Saitama, Japan
Investigational Site Number : 3920005
Kawagoe, Saitama, Japan
Investigational Site Number : 3920014
Yaizu, Shizuoka, Japan
Investigational Site Number : 3920008
Kodaira, Tokyo, Japan
Investigational Site Number : 3920010
Ōta-ku, Tokyo, Japan
Investigational Site Number : 3920001
Chiba, , Japan
Investigational Site Number : 3920009
Saga, , Japan
Investigational Site Number : 4840002
Chihuahua City, , Mexico
Investigational Site Number : 4840001
Tlalnepantla, , Mexico
Investigational Site Number : 6200003
Braga, , Portugal
Investigational Site Number : 6200005
Coimbra, , Portugal
Investigational Site Number : 6200002
Lisbon, , Portugal
Investigational Site Number : 6200001
Lisbon, , Portugal
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Sabadell, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240008
Majadahonda, Madrid, Spain
Investigational Site Number : 7240002
Pamplona, Navarre, Spain
Investigational Site Number : 7240003
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240007
Málaga, , Spain
Investigational Site Number : 7240004
Valencia, , Spain
Investigational Site Number : 7520001
Stockholm, , Sweden
Investigational Site Number : 7560001
Basel, , Switzerland
Investigational Site Number : 7560003
Bern, , Switzerland
Investigational Site Number : 1580003
Kaohsiung City, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 1580002
Taipei, , Taiwan
Investigational Site Number : 7920004
Bursa, , Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Konya, , Turkey (Türkiye)
Investigational Site Number : 8260007
London, England, United Kingdom
Investigational Site Number : 8260003
Inverness, Highland, United Kingdom
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
Access external resources that provide additional context or updates about the study.
EFC18156 (Vitalize) \& EFC17236 (MOBILIZE) CIDP website-for potential participants
EFC18156 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1295-3363
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508338-33
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC18156
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.