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Набира участници Фаза 3 NCT06290141

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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Chronic Inflammatory Demyelinating Polyneuropathy

Спонсор: Sanofi

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
riliprubart
DRUG
Placebo
DRUG
riliprubart
DRUG
Placebo
DRUG
IVIg
DRUG
Placebo
DRUG
Места на провеждане 115
Argentina (3)
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320002
Buenos Aires
Investigational Site Number : 0320003
Buenos Aires
Белгия (2)
Investigational Site Number : 0560002
Ghent
COMPLETED
Investigational Site Number : 0560001
Leuven
Бразилия (4)
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
Brasília , Federal District
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
Curitiba , Paraná
InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002
Porto Alegre , Rio Grande do Sul
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo
Канада (3)
Investigational Site Number : 1240003
London , Ontario
Investigational Site Number : 1240006
Montreal , Quebec
Investigational Site Number : 1240001
Québec , Quebec
Китай (17)
Investigational Site Number : 1560013
Beijing
Investigational Site Number : 1560010
Beijing
Investigational Site Number : 1560005
Beijing
Investigational Site Number : 1560017
Beijing
Investigational Site Number : 1560009
Changsha
Investigational Site Number : 1560011
Chengdu
Investigational Site Number : 1560002
Fuzhou
Investigational Site Number : 1560012
Guangzhou
Investigational Site Number : 1560007
Guangzhou
Investigational Site Number : 1560014
Hangzhou
Investigational Site Number : 1560016
Jiazhuang
Investigational Site Number : 1560008
Jinan
Investigational Site Number : 1560015
Nanchang
Investigational Site Number : 1560001
Shanghai
Investigational Site Number : 1560003
Wuhan
Investigational Site Number : 1560006
Wuhan
Investigational Site Number : 1560004
Xi'an
Чехия (5)
Investigational Site Number : 2030004
Brno
Investigational Site Number : 2030003
Hradec Králové
Investigational Site Number : 2030005
Ostrava
Investigational Site Number : 2030002
Pardubice
COMPLETED
Investigational Site Number : 2030001
Prague
Дания (2)
Investigational Site Number : 2080002
Aarhus
Investigational Site Number : 2080001
Copenhagen
Франция (4)
Investigational Site Number : 2500001
Le Kremlin-Bicêtre
Investigational Site Number : 2500002
Marseille
Investigational Site Number : 2500005
Nice
Investigational Site Number : 2500003
Paris
Германия (5)
Investigational Site Number : 2760003
Berlin
Investigational Site Number : 2760008
Bochum
Investigational Site Number : 2760006
Göttingen
Investigational Site Number : 2760005
Hanover
Investigational Site Number : 2760001
Münster
Унгария (3)
Investigational Site Number : 3480003
Budapest
Investigational Site Number : 3480004
Győr
Investigational Site Number : 3480001
Szeged
Израел (1)
Investigational Site Number : 3760001
Haifa
Италия (2)
Investigational Site Number : 3800002
Bologna
Investigational Site Number : 3800001
Padua , Padova
Япония (9)
Investigational Site Number : 3920007
Amagasaki , Hyōgo
Investigational Site Number : 3920001
Chiba
Investigational Site Number : 3920012
Higashi-Matsuyama , Saitama
Investigational Site Number : 3920005
Kawagoe , Saitama
Investigational Site Number : 3920008
Kodaira , Tokyo
Investigational Site Number : 3920010
Ōta-ku , Tokyo
Investigational Site Number : 3920009
Saga
Investigational Site Number : 3920014
Yaizu , Shizuoka
Investigational Site Number : 3920015
Yokohama , Kanagawa
Mexico (2)
Investigational Site Number : 4840002
Chihuahua City
Investigational Site Number : 4840001
Tlalnepantla
Норвегия (1)
Investigational Site Number : 5780001
Oslo
Португалия (4)
Investigational Site Number : 6200003
Braga
Investigational Site Number : 6200005
Coimbra
Investigational Site Number : 6200002
Lisbon
Investigational Site Number : 6200001
Lisbon
Испания (10)
Investigational Site Number : 7240009
Barcelona , Barcelona [Barcelona]
Investigational Site Number : 7240001
Barcelona , Catalunya [Cataluña]
Investigational Site Number : 7240008
Majadahonda , Madrid
Investigational Site Number : 7240007
Málaga
Investigational Site Number : 7240003
Oviedo , Principality of Asturias
Investigational Site Number : 7240002
Pamplona , Navarre
Investigational Site Number : 7240006
Sabadell , Barcelona [Barcelona]
Investigational Site Number : 7240010
Santa Cruz de Tenerife
Investigational Site Number : 7240012
Santiago de Compostela , A Coruña [La Coruña]
Investigational Site Number : 7240004
Valencia
Швеция (1)
Investigational Site Number : 7520001
Stockholm
Швейцария (2)
Investigational Site Number : 7560001
Basel
Investigational Site Number : 7560003
Bern
Taiwan (3)
Investigational Site Number : 1580003
Kaohsiung City
Investigational Site Number : 1580001
Taipei
Investigational Site Number : 1580002
Taipei
Турция (4)
Investigational Site Number : 7920004
Bursa
Investigational Site Number : 7920001
Istanbul
Investigational Site Number : 7920002
Istanbul
Investigational Site Number : 7920003
Konya
Великобритания (3)
Investigational Site Number : 8260003
Inverness , Highland
Investigational Site Number : 8260007
London , England
Investigational Site Number : 8260001
Oxford , Oxfordshire
САЩ (25)
Dent Neurologic Institute - Amherst- Site Number : 8400039
Amherst , New York
Austin Neuromuscular Center- Site Number : 8400040
Austin , Texas
Johns Hopkins Hospital- Site Number : 8400015
Baltimore , Maryland
Massachusetts General Hospital- Site Number : 8400009
Boston , Massachusetts
University of Vermont Medical Center- Site Number : 8400012
Burlington , Vermont
University of Virginia- Site Number : 8400023
Charlottesville , Virginia
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati , Ohio
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland , Ohio
Henry Ford Hospital- Site Number : 8400025
Detroit , Michigan
Michigan State University- Site Number : 8400038
East Lansing , Michigan
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview , Illinois
Alabama Neurology Associates- Site Number : 8400019
Homewood , Alabama
University of Kansas Medical Center- Site Number : 8400010
Kansas City , Kansas
Keck School of Medicine of University of Southern California- Site Number : 8400002
Los Angeles , California
Yale University School of Medicine- Site Number : 8400018
New Haven , Connecticut
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans , Louisiana
Hospital for Special Surgery- Site Number : 8400041
New York , New York
Columbia University Irving Medical Center- Site Number : 8400003
New York , New York
University of California Irvine Medical Center- Site Number : 8400007
Orange , California
AdventHealth Orlando- Site Number : 8400006
Orlando , Florida
AdventHealth Site Number : 8400006
Orlando , Florida
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia , Pennsylvania
Raleigh Neurology Associates- Site Number : 8400043
Raleigh , North Carolina
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
Scottsdale , Arizona
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
St Louis , Missouri
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.08.2024
Крайна дата
12.01.2029
Регистрационен номер
NCT06290141
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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