Clinical trial • Phase III • Neurology|Immunology|Rare Disease

RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy

Phase III trial of RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy.

Overview

Trial Therapeutic Area
Neurology|Immunology|Rare Disease
Trial Disease
Chronic inflammatory demyelinating polyneuropathy
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
23-02-2024
First CTIS Authorization Date
17-06-2024

Trial design

Randomised, placebo (riliprubart placebo, solution for injection in prefilled pen or in vial). dose and schedule for the placebo arm are not specified in the public record.-controlled Phase III trial in Bulgaria, Denmark, Belgium and others.

Randomised
Yes
Comparator
Placebo (riliprubart placebo, solution for injection in prefilled pen or in vial). Dose and schedule for the placebo arm are not specified in the public record.
Target Sample Size
118

Eligibility

Recruits 118 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided for participants and for partner/ pregnancy and caregiver contexts (documents include L1-sis-icf-patient, L1-sis-icf-caregiver, L1-sis-icf-partner-pregnancy, and country-specific ICFs). Consent is obtained via the provided ICFs; caregiver and partner information/consent documents are available. No paediatric/assent forms are provided in the record..

Pregnancy Exclusion
Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided for participants and for partner/ pregnancy and caregiver contexts (documents include L1-sis-icf-patient, L1-sis-icf-caregiver, L1-sis-icf-partner-pregnancy, and country-specific ICFs). Consent is obtained via the provided ICFs; caregiver and partner information/consent documents are available. No paediatric/assent forms are provided in the record.

Inclusion criteria

  • {"criterion_text":"- 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).\n- All participants must agree to use contraception methods during and after the study as required.\n- A body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive\n- 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. -- Male participants are 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 --- 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: ---- A male condom and an additional highly effective contraceptive method as described in the protocol. -- 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 woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), as described in Appendix 10.4 Contraception and barrier guidance 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.\n- Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP (including motor predominant), multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.\n- 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, defined as no clinically meaningful improvement or persistent INCAT score ≥2 after a minimum of: ---One dose of IVIg of 2 g/kg, followed by either a second dose of 2 g/kg, or at least 2 doses of 1 g/kg, with a separation of approximately 3 weeks between doses (each dose can be divided over 2 to 5 days), as indicated in the EAN/PNS 2021 guidelines OR ---SCIg maintenance therapy with at least 0.2 g/kg weekly for 5 weeks --Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score ≥2 after a minimum of 12 weeks of corticosteroid therapy. Corticosteroid regimen can be daily oral prednisone/prednisolone, at least 60 mg, equivalent to methylprednisolone 48 mg, tapered over 6 to 8 months, or alternative regimens, e.g. pulsed high-dose corticosteroid treatment (40 mg/day oral dexamethasone or 500 mg/day IV methylprednisolone, each daily for 4 days per month for 6 months), as indicated in the EAN/PNS 2021 guidelines A clinically meaningful improvement is defined as one or more of the following: ---A ≥1 point decrease in adjusted INCAT disability score ---An increase in I-RODS centile score ≥4 points ---An increase in MRC Sum score ≥3 points ---An improvement in hand grip strength of ≥8 kilopascals or ---Equivalent improvement based on information from medical records and per the Investigator’s judgment\n- Participant has an INCAT score of 2 to 9 (a score of 2 should be exclusively from the leg disability component of INCAT).\n- Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months at a stable dose for ≥3 months prior to Screening\n- Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone [or equivalent dose for other oral corticosteroids]), but only if taken at a stable dose for ≥3 months prior to Screening\n- Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening\n- 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"}

Exclusion criteria

  • {"criterion_text":"- 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.\n- 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\n- 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.\n- Sensory CIDP, Distal CIDP and focal CIDP variants.\n- Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening)\n- 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\n- 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.\n- 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 --anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies\n- Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation\n- Accommodation in an institution because of regulatory or legal order; eg, imprisoned or legally institutionalized\n- 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\n- Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse\n- 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\n- Any country related specific regulation that would prevent the participant from entering the study\n- Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments\n- Poorly controlled diabetes (HbA1c >7% at the Screening visit)\n- Serious infections requiring hospitalization within 30 days prior to Screening and 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)\n- 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.\n- 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.\n- 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.\n- 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.\n- Treatment with efgartigimod within 8 weeks prior to screening\n- Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk\n- Participant has received immunoglobulins (IVIg or SCIg) within 12 weeks prior to Screening\n- Treatment with plasma exchange within the 8 weeks prior to Screening\n- Prior treatment with riliprubart\n- Prior treatment with (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine\n- Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation\n- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants experiencing a response","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants randomized to riliprubart with lasting response","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants randomized to placebo who experience a response","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in grip strength (kilopascals; dominant hand)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in Medical Research Council Sum Score (MRC-SS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants refractory to immunoglobulins experiencing a response","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence and titer of anti-riliprubart antibodies (ADA)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence and titer of anti-riliprubart antibodies","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in I-RODS score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in adjusted INCAT score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in grip strength (kilopascals; dominant hand)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in MRC-SS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in EQ-5D-5L score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in RT-FSS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants randomized to riliprubart who experience a response at Week 48 without prior response in Part A (delayed response)","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
118
Recruitment Window Months
40
Consent Approach
Informed consent obtained using subject information and informed consent forms (L1-sis-icf files). ICFs and participant information materials are provided in multiple languages (English and country-specific translations present, including but not limited to: BG, EN, FR, NL, DA, CS, DE, EL, IT, PL, PT, ES, SV). There are separate ICF/information documents for caregivers and for partners (pregnancy-related partner information), indicating caregiver/partner-specific consent/information handling. Consent is provided by adult participants via these ICFs; no paediatric assent forms are present in the public documents.

Methods

  • Posters and printed trifold leaflets for participants (country-specific versions present: e.g., 'K2-recruitment-material-trifold-<lang>')
  • Participant letters and appointment cards (country-specific 'participant-letter' and 'appointment-card' recruitment materials)
  • Healthcare professional (HCP) outreach letters ('K2-recruitment-material-hcp-letter-<lang>')
  • Trust-builder and informational materials for participants ('K2-recruitment-material-trust-builder-<lang>')
  • Digital methods: social media posts and captions ('K2-recruitment-material-social-media-post-<lang>' and caption documents), website pages ('sanofi-studies-webpage-<lang>'), and email templates
  • Pre-screener questionnaires and prescreener tools ('sanofi-studies-prescreener' and 'prescreener' materials) to identify potential participants
  • Placebo educational modules and videos and related materials used as part of recruitment content (country-specific 'placebo' modules and scripts)

Geography

Total Number Of Sites
54
Total Number Of Participants
118

Bulgaria

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
504
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD (#1)
Contact Person Name
Vanya Rizova
Contact Person Email
vania.zlatkova@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Department of Multiple Sclerosis,
Contact Person Name
Ivan MILANOV

Denmark

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
05-10-2025
Processing Time Days
502
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Aarhus Universitetshospital
Department Name
Neurologisk Afdeling, Aarhus Universitetshospital
Contact Person Name
Thomas Harbo
Contact Person Email
thomas.harbo@rm.dk
Site Name
Rigshospitalet
Department Name
Copenhagen Neuromuscular Center
Contact Person Name
Tina Dysgaard
Contact Person Email
tina.dysgaard@regionh.dk

Belgium

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
499
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
UZ Leuven
Department Name
UZ Leuven Campus Gasthuisberg
Contact Person Name
Kristl Claeys
Contact Person Email
kristl.claeys@uzleuven.be

Sweden

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
555
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Region Stockholm – SLSO
Department Name
Akademiskt Specialistcentrum
Contact Person Name
Ivan Kmezic
Contact Person Email
ivan.kmezic@regionstockholm.se

Poland

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
561
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Indywidualna Praktyka Lekarska Prof. Dr hab Konrad Rejdak
Contact Person Name
Konrad Rejdak
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddzial Kliniczny Neurologii
Contact Person Name
Agnieszka Slowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Contact Person Name
Halina Bartosik-Psujek
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddzial Neurologiczny
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
msowa@sum.edu.pl

France

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
542
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Groupe Hospitalier Pitie Salpetriere( #1)
Contact Person Name
Karine VIALA
Contact Person Email
karine.viala@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie Adulte - Centre de Reference des Maladies Rares
Contact Person Name
Andoni Echaniz-Laguna
Contact Person Email
andoni.echaniz-laguna@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
CHRU de Lille - Hopital Roger Salengro( #1)
Contact Person Name
Celine Tard
Contact Person Email
celine.tard@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
CHRU Gui De Chauliac
Contact Person Name
Guillaume Taieb
Contact Person Email
g-taieb@chu-montpellier.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
APHM - Hopital De La Timone( #1)
Contact Person Name
Shahram Attarian
Contact Person Email
shahram.attarian@ap-hm.fr

Germany

Earliest CTIS Part Ii Submission Date
25-07-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
510
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Department Name
Zentrum for klinische Forschung Dr. med. Irma Schoell
Contact Person Name
Elvira Steidl
Contact Person Email
dr.steidl@dr-schoell.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Neurologie
Contact Person Name
Aexander Grimm
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Kinik für Neurologie
Contact Person Name
Anna Lena Fisse
Contact Person Email
anna.fisse@klinikum-bochum.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Universitätsklinikum Gießen und Marburg GmbH
Contact Person Name
Steffan Pfeuffer
Site Name
Katholisches Klinikum Berlin (Neurologie Berlin, Clinical Practice and Study Center)
Department Name
Neurologie Berlin
Contact Person Name
Marie Brinckmann
Site Name
Universitaetsklinikum Essen AöR
Department Name
Universitätsklinikum Essen Neurologie
Contact Person Name
Mark Stettner
Contact Person Email
mark.stettner@uk-essen.de

Greece

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
619
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
General University Hospital Of Larissa
Department Name
Department of Neurology
Contact Person Name
Efthimios Dardiotis
Contact Person Email
edar@med.uth.gr
Site Name
University General Hospital Attikon
Department Name
2nd department of Neurology clinic
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
B’ Dept of Neurology
Contact Person Name
Nikolaos GRIGORIADIS
Contact Person Email
grigoria@med.auth.gr

Czechia

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
541
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologicka klinika
Contact Person Name
Pavel Kunc
Contact Person Email
pavel.kunc@fnhk.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurologicka klinika
Contact Person Name
Edvard EHLER
Contact Person Email
edvard.ehler@nempk.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Neurologicka klinika
Contact Person Name
Josef Bednarik
Contact Person Email
bednarik.josef@fnbrno.cz

Spain

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
553
Number Of Sites
10
Number Of Participants
8

Sites

Site Name
Hospital Universitario Basurto
Department Name
Hospital de Basurto
Contact Person Name
Solange Kapetanovic
Site Name
Hospital Universitario De Navarra
Department Name
Hospital Universitario de Navarra (#1)
Contact Person Name
Maria Ivonne Jerico Pascual
Contact Person Email
ijericop@cfnavarra.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Hospital Universitario Central de Asturias( #1)
Contact Person Name
German Moris de la Tassa
Contact Person Email
german.moris@sespa.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hospital de la Santa Creu i Sant Pau( #1)
Contact Person Name
Luis Querol Gutierrez
Contact Person Email
lquerol@santpau.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hospital Universitari i Politecnic La Fe( #1)
Contact Person Name
Teresa Sevilla Mantecon
Contact Person Email
sevilla_ter@gva.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hospital Universitario Puerta De Hierro Majadahonda( #1)
Contact Person Name
Lorenzo Silva Hernandez
Contact Person Email
lorenzo.silvaher@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hospital Universitari Vall D Hebron
Contact Person Name
Raul Juntas
Contact Person Email
raul.juntas@vallhebron.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
Hospital Universitario Parc Taulí
Contact Person Name
Espinosa Jorge
Contact Person Email
JEspinosa@tauli.cat
Site Name
Hospital Universitario Nuestra Senora De Candelaria
Department Name
Hospital Universitario Nuestra Señora de la Candelaria
Contact Person Name
Jorge Alonso Perez
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Hospital Clinico Universitario de Santiago
Contact Person Name
Beatrice Canneti
Contact Person Email
canneti.heredia@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
594
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Centro Hospitalar De Lisboa Ocidental E.P.E.
Department Name
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz( #1)
Contact Person Name
Andre Caetano
Contact Person Email
apcaetano@chlo.min-saude.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Pneumology department
Contact Person Name
Luciano Almendra
Contact Person Email
10365@ulscoimbra.min-saude.pt
Site Name
Centro Hospitalar Universitario Lisboa Central E.P.E.
Department Name
Centro Hospitalar de Lisboa Central (#1)
Contact Person Name
Marisa Brum
Contact Person Email
marisatbrum@gmail.com
Site Name
Hospital Pedro Hispano
Department Name
Unidade Local de Saude de Matosinhos-Hospital Pedro Hispano( #1)
Contact Person Name
Raquel Rocha
Contact Person Email
rmrocha84@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Unidade Local de Saude de Santa Maria
Contact Person Name
Mamede de Carvalho

Italy

Earliest CTIS Part Ii Submission Date
06-06-2024
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
624
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Neurologia
Contact Person Name
Luca Leonardi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Funzionale di Malattie Neuromuscolari
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Neurologia
Contact Person Name
Giulia Ricci
Contact Person Email
giulia.ricci@med.unipi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (#1)
Contact Person Name
Mario Sabatelli
Contact Person Email
mario.sabatelli@unicatt.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Contact Person Name
SALVATORE COTTONE
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata (#1)
Contact Person Name
Girolama Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Neuroimmunology and Neuromuscular Service
Contact Person Name
Pietro Emiliano Doneddu
Contact Person Email
pietro.e.doneddu@gmail.com
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina (#1)
Contact Person Name
Antonio Toscano
Contact Person Email
atoscano@unime.it
Site Name
Neurological Institute Foundation Casimiro Mondino
Department Name
Istituto Neurologico Casimiro Mondino( #1)
Contact Person Name
Luca Diamanti
Contact Person Email
luca.diamanti@mondino.it

Netherlands

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
622
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Department of Neurology
Contact Person Name
Filip Eftimov
Contact Person Email
f.eftimov@amc.uva.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Department of Neurology Nf329
Contact Person Name
Krista Kuitwaard
Contact Person Email
k.kuitwaard@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Suvoda LLC
Responsibilities
Sponsor duties code: 3
Name
Pharmaceutical Product Development LLC
Responsibilities
Sponsor duties code: 4
Name
Eresearchtechnology Inc.
Responsibilities
Sponsor duties code: 7

Third parties

  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"Sponsor duties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Sponsor duties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"Sponsor duties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duties code: 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
riliprubart
Active Substance
RILIPRUBART
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION; INTRAVENIOUS INFUSION
Route
SUBCUTANEOUS INJECTION; INTRAVENIOUS INFUSION
Orphan Designation
Yes
Dose Levels
Reported maxima: 600 mg (prefilled pen formulation); 50 mg/kg (intravenous formulation)
Maximum Dose
600 mg (prefilled pen), 50 mg/kg (IV)
Investigational Product Name
riliprubart placebo, solution for injection in prefilled pen (PFP)
Modality
Other
Investigational Product Name
riliprubart placebo, solution for injection in vial
Modality
Other

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