Clinical trial • Not applicable • Immunology|Rare Disease

RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy

Not applicable trial of RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy. open-label. 204 participants.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Chronic inflammatory demyelinating polyneuropathy
Trial Stage
Not applicable
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
10-12-2024
First CTIS Authorization Date
22-04-2025

Trial design

open-label Not applicable trial across 60 sites in Belgium, Bulgaria, Denmark and others.

Open Label
Yes
Target Sample Size
204
Trial Duration For Participant
1080

Eligibility

Recruits 204 Vulnerable population selected. The protocol requires that participants be capable of giving signed informed consent as described in Appendix 1 of the protocol. Subject information and informed consent forms (ICFs) and partner/caregiver information/ICF documents are provided in multiple languages (see publication documents). Assent procedures for minors are not mentioned in the available documentation..

Pregnancy Exclusion
Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.
Vulnerable Population
Vulnerable population selected. The protocol requires that participants be capable of giving signed informed consent as described in Appendix 1 of the protocol. Subject information and informed consent forms (ICFs) and partner/caregiver information/ICF documents are provided in multiple languages (see publication documents). Assent procedures for minors are not mentioned in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Participants with chronic inflammatory demyelinating polyneuropathy (CIDP) currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, or Study EFC18156. (Participants receiving riliprubart in Part C of PDY16744 are eligible after completing the Part C End of Treatment visit.)\n- All participants must agree to use contraception methods during and after the study as required. 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.\n- Participant must be capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n- Clinical diagnosis of systemic lupus erythematosus (SLE).\n- History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n- Any country-related specific regulation that would prevent the participant from entering the study.\n- Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized.\n- Unsuitability for participation as judged by the Investigator, whatever the reason, including: medical or clinical condition, potential risk of participant noncompliance with study procedures, or any other clinically significant change in the participants’ medical condition."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants having any adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, electrocardiograms (ECGs), and vital signs during the study period.","definition_or_measurement_approach":"Count of participants experiencing AEs, SAEs, treatment-discontinuing AEs, AESIs, and potentially clinically significant abnormalities identified via safety laboratory tests, ECGs, and vital signs recorded during the study period."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156).","definition_or_measurement_approach":"Proportion (percentage) of participants with no relapse recorded since first dose of riliprubart in the parent study."}
  • {"endpoint_text":"- Percentage of participants experiencing improvement from baseline.","definition_or_measurement_approach":"Proportion (percentage) of participants with clinical improvement compared with baseline assessments (as defined in protocol)."}
  • {"endpoint_text":"- Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time.","definition_or_measurement_approach":"Change from baseline in adjusted INCAT disability score measured at scheduled visits over time."}
  • {"endpoint_text":"- Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time.","definition_or_measurement_approach":"Change from baseline in I-RODS score measured at scheduled visits over time."}
  • {"endpoint_text":"- Change from baseline in grip strength (kilopascals; dominant hand) over time.","definition_or_measurement_approach":"Change from baseline in grip strength (kPa) of the dominant hand measured at scheduled visits over time."}
  • {"endpoint_text":"- Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time.","definition_or_measurement_approach":"Change from baseline in MRC-SS for muscle strength measured at scheduled visits over time."}

Recruitment

Planned Sample Size
204
Recruitment Window Months
51
Consent Approach
Participants must provide signed informed consent as described in Appendix 1 of the protocol. Subject information and ICF documents (patient, partner/pregnancy, caregiver) are provided in multiple country-specific language versions (examples in the public documents: EN, FR, NL, BG, DA, CS, PL, PT, ES, SV, HU, IT, DE, EL). The protocol requires participants be capable of signing consent; caregiver/partner information and ICFs are available. Assent for minors is not specified.

Geography

Total Number Of Sites
60
Total Number Of Participants
155

Belgium

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
24-04-2025
Processing Time Days
20
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
UZ Gent (#1)
Contact Person Name
Sarah Herdewyn
Contact Person Email
sarah.herdewyn@uzgent.be
Site Name
UZ Leuven
Department Name
UZ Leuven Campus Gasthuisberg
Contact Person Name
Kristl Claeys
Contact Person Email
kristl.claeys@uzleuven.be

Bulgaria

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
17
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Department
Contact Person Name
Maya P Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
MHATNP "Sveti Naum"
Contact Person Name
Ivan Gospodinov MILANOV
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Contact Person Name
Vanya Zlatkova Rizova
Contact Person Email
dr.zlatkova@mbalpuls.com

Denmark

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
23-04-2025
Processing Time Days
19
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Rigshospitalet
Department Name
Neuromuskulær Forskning
Contact Person Name
Tina Dysgaard
Contact Person Email
tina.dysgaard@regionh.dk
Site Name
Region Midtjylland
Department Name
Neurologisk Afdeling
Contact Person Name
Thomas Harbo
Contact Person Email
Thomas.Harbo@rm.dk

Czechia

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
23-04-2025
Processing Time Days
20
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologická klinika 1.LF UK a VFN
Principal Investigator Name
Michaela Tyblova
Principal Investigator Email
mtyblova@seznam.cz
Contact Person Name
Michaela Tyblova
Contact Person Email
mtyblova@seznam.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Neurologická klinika
Principal Investigator Name
Josef Bednařík
Principal Investigator Email
bednarik.josef@fnbrno.cz
Contact Person Name
Josef Bednařík
Contact Person Email
bednarik.josef@fnbrno.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurologická klinika
Principal Investigator Name
Edvard Ehler
Principal Investigator Email
edvard.ehler@nempk.cz
Contact Person Name
Edvard Ehler
Contact Person Email
edvard.ehler@nempk.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Neurologická klinika
Principal Investigator Name
Jana Junkerová
Principal Investigator Email
jana.junkerova@fno.cz
Contact Person Name
Jana Junkerová
Contact Person Email
jana.junkerova@fno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologická klinika
Principal Investigator Name
Pavel Kunc
Principal Investigator Email
pavel.kunc@fnhk.cz
Contact Person Name
Pavel Kunc
Contact Person Email
pavel.kunc@fnhk.cz

Sweden

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
105
Number Of Sites
1
Number Of Participants
3

Sites

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

Poland

Earliest CTIS Part Ii Submission Date
01-04-2025
Latest Decision Or Authorization Date
27-04-2025
Processing Time Days
26
Number Of Sites
4
Number Of Participants
11

Sites

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
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Kliniczny Oddzial Neurologii
Principal Investigator Name
Konrad Rejdak
Principal Investigator Email
rejdakk@ail.com
Contact Person Name
Konrad Rejdak
Contact Person Email
rejdakk@ail.com
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Department Name
NA - private site
Contact Person Name
Halina BARTOSIK-PSUJEK
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Principal Investigator Name
Konrad Rejdak
Principal Investigator Email
rejdakk@gmail.com
Contact Person Name
Konrad Rejdak
Contact Person Email
rejdakk@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
10-04-2025
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
18
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
University Of Szeged
Department Name
Neurológiai Klinika
Principal Investigator Name
Peter Klivenyi
Principal Investigator Email
klivenyi.peter@med.u-szeged.hu
Contact Person Name
Peter Klivenyi
Contact Person Email
klivenyi.peter@med.u-szeged.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Neurológiai Osztály
Principal Investigator Name
Attila Csanyi
Principal Investigator Email
csanyia@petz.gyor.hu
Contact Person Name
Attila Csanyi
Contact Person Email
csanyia@petz.gyor.hu
Site Name
Eszak-Budai Szent Janos Centrumkorhaz
Department Name
Neurológiai Osztály
Principal Investigator Name
Ferenc Fazekas
Principal Investigator Email
dr.f.fazekas@gmail.com
Contact Person Name
Ferenc Fazekas
Contact Person Email
dr.f.fazekas@gmail.com
Site Name
Semmelweis University
Department Name
Neurológiai Klinika
Principal Investigator Name
Magdolna Simo
Principal Investigator Email
simo.magdolna@semmelweis.hu
Contact Person Name
Magdolna Simo
Contact Person Email
simo.magdolna@semmelweis.hu

Portugal

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
24-04-2025
Processing Time Days
17
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Unidade Local Saude Coimbra Hospitalar Universitario de Coimbra
Principal Investigator Name
Luciano Almendra
Principal Investigator Email
10365@ulscoimbra.min-saude.pt
Contact Person Name
Luciano Almendra
Contact Person Email
10365@ulscoimbra.min-saude.pt
Site Name
Hospital Pedro Hispano
Department Name
Unidade Local Saude Matosinhos, EPE, Pedro Hispano
Principal Investigator Name
Rocha Raquel
Principal Investigator Email
raquel.rocha@ulsm.min-saude.pt
Contact Person Name
Rocha Raquel
Contact Person Email
raquel.rocha@ulsm.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Unidade Local Saude de Sao Jose - Hospital Sao Jose
Principal Investigator Name
Marisa Tavares
Principal Investigator Email
marisatbrum@gmail.com
Contact Person Name
Marisa Tavares
Contact Person Email
marisatbrum@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Unidade Local Saude Braga
Principal Investigator Name
Ricardo Mare
Principal Investigator Email
ricardo.mare@gmail.com
Contact Person Name
Ricardo Mare
Contact Person Email
ricardo.mare@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Neurology
Principal Investigator Name
Andre Caetano
Principal Investigator Email
apcaetano@chlo.min-saude.pt
Contact Person Name
Andre Caetano
Contact Person Email
apcaetano@chlo.min-saude.pt

Spain

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
105
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Principal Investigator Name
Raul Juntas Morales
Principal Investigator Email
raul.juntas@vallhebron.cat
Contact Person Name
Raul Juntas Morales
Contact Person Email
raul.juntas@vallhebron.cat
Site Name
Hospital Universitario Central De Asturias
Department Name
0034985108000
Principal Investigator Name
German Moris de la Tassa
Principal Investigator Email
german.moris@sespa.es
Contact Person Name
German Moris de la Tassa
Contact Person Email
german.moris@sespa.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Principal Investigator Name
Teresa Sevilla
Principal Investigator Email
sevilla_ter@gva.es
Contact Person Name
Teresa Sevilla
Contact Person Email
sevilla_ter@gva.es
Site Name
Hospital Universitario De Navarra
Department Name
Neurology
Principal Investigator Name
Ivonne Jericó Pascual
Principal Investigator Email
ivonne.jerico.pascual@navarra.es
Contact Person Name
Ivonne Jericó Pascual
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Principal Investigator Name
Luis Antonio Querol Gutiérrez
Principal Investigator Email
lquerol@santpau.cat
Contact Person Name
Luis Antonio Querol Gutiérrez
Contact Person Email
lquerol@santpau.cat
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Neurology
Principal Investigator Name
Lorenzo Silva Hernandez
Principal Investigator Email
lorenzo.silvaher@gmail.com
Contact Person Name
Lorenzo Silva Hernandez
Contact Person Email
lorenzo.silvaher@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Consorci Corporació Sanitària Parc Taulí de Sabadell
Principal Investigator Name
Jorge Espinosa
Principal Investigator Email
JEspinosa@tauli.cat
Contact Person Name
Jorge Espinosa
Contact Person Email
JEspinosa@tauli.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Hospital Regional Universitario de Málaga
Principal Investigator Name
Virginia Reyes
Principal Investigator Email
v.reyes.eecc@gmail.com
Contact Person Name
Virginia Reyes
Contact Person Email
v.reyes.eecc@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
24-04-2025
Processing Time Days
21
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Universitaetsmedizin Goettingen
Department Name
Neurologie
Principal Investigator Name
Jana Zschuentzsch
Principal Investigator Email
j.zschuentzsch@med.uni-goettingen.de
Contact Person Name
Jana Zschuentzsch
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Neurologie
Principal Investigator Name
Alexander Grimm
Principal Investigator Email
alexander.grimm@med.uni-tuebingen.de
Contact Person Name
Alexander Grimm
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Neurologie
Principal Investigator Name
Gerd Meyer zu Hoerste
Principal Investigator Email
gerd.meyerzuhoerste@ukmuenster.de
Contact Person Name
Gerd Meyer zu Hoerste

Italy

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
105
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Neurologia
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
filippi.massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica Neurologica - IRCCS Ospedale Policlinico San Martino
Principal Investigator Name
Angelo Schenone
Principal Investigator Email
aschenone@neurologia.unige.it
Contact Person Name
Angelo Schenone
Contact Person Email
aschenone@neurologia.unige.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Centro Sclerosi Multipla
Principal Investigator Name
Girolama Marfia
Principal Investigator Email
marfia@uniroma2.it
Contact Person Name
Girolama Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Neurologia
Principal Investigator Name
Salvatore Cottone
Principal Investigator Email
salvatore.cottone1@arnascivico.it
Contact Person Name
Salvatore Cottone
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Neurologia
Principal Investigator Name
Giulia Ricci
Principal Investigator Email
giulia.ricci@med.unipi.it
Contact Person Name
Giulia Ricci
Contact Person Email
giulia.ricci@med.unipi.it
Site Name
Azienda Ospedaliero Universitaria Gaetano Martino Messina
Department Name
Neurologia e MNM
Principal Investigator Name
Antonio Toscano
Principal Investigator Email
atoscano@unime.it
Contact Person Name
Antonio Toscano
Contact Person Email
atoscano@unime.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
IRCCS Istituto Clinico Humanitas
Principal Investigator Name
Giuseppe Liberatore
Principal Investigator Email
giuseppe.liberatore@humanitas.it
Contact Person Name
Giuseppe Liberatore
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
Istituto Neurologico Casimiro Mondino( #1)
Principal Investigator Name
Luca Diamanti
Principal Investigator Email
luca.diamanti@mondino.it
Contact Person Name
Luca Diamanti
Contact Person Email
luca.diamanti@mondino.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Neurologia
Principal Investigator Name
Luca Leonardi
Principal Investigator Email
leonardi.luca89@gmail.com
Contact Person Name
Luca Leonardi
Contact Person Email
leonardi.luca89@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dipartimento di Neuroscienze, Organi di senso e Torace
Principal Investigator Name
Mario Sabatelli
Principal Investigator Email
mario.sabatelli@unicatt.it
Contact Person Name
Mario Sabatelli
Contact Person Email
mario.sabatelli@unicatt.it

Greece

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
105
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
2nd Department of Neurology
Principal Investigator Name
Nikolaos Grigoriadis
Principal Investigator Email
ngrigoriadis@auth.gr
Contact Person Name
Nikolaos Grigoriadis
Contact Person Email
ngrigoriadis@auth.gr
Site Name
University General Hospital Attikon
Department Name
2nd Department of Neurology clinic
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
tsivgoulisgiorg@yahoo.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr
Site Name
General University Hospital Of Larissa
Department Name
Department of Neurology
Principal Investigator Name
Efthimios Dardiotis
Principal Investigator Email
edar@med.uth.gr
Contact Person Name
Efthimios Dardiotis
Contact Person Email
edar@med.uth.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st neurology dpt of AHEPA Hospital
Principal Investigator Name
Vasilios Kimiskidis
Principal Investigator Email
kimiskid@med.auth.gr
Contact Person Name
Vasilios Kimiskidis
Contact Person Email
kimiskid@med.auth.gr

Netherlands

Earliest CTIS Part Ii Submission Date
02-04-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
20
Number Of Sites
2
Number Of Participants
5

Sites

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

France

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
28
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Neurophysiologie clinique
Principal Investigator Name
Karine VIALA
Principal Investigator Email
karine.viala@aphp.fr
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
Principal Investigator Name
Andoni Echaniz-Laguna
Principal Investigator Email
andoni.echaniz-laguna@aphp.fr
Contact Person Name
Andoni Echaniz-Laguna
Contact Person Email
andoni.echaniz-laguna@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Neurologie
Principal Investigator Name
Gwendal Le-Masson
Principal Investigator Email
gwendal.le-masson@chu-bordeaux.fr
Contact Person Name
Gwendal Le-Masson
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Neurologie
Principal Investigator Name
Celine Tard
Principal Investigator Email
celine.tard@chu-lille.fr
Contact Person Name
Celine Tard
Contact Person Email
celine.tard@chu-lille.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de Neurologie
Principal Investigator Name
SHAHRAM ATTARIAN
Principal Investigator Email
Shahram.ATTARIAN@ap-hm.fr
Contact Person Name
SHAHRAM ATTARIAN
Contact Person Email
Shahram.ATTARIAN@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
CHRU Gui De Chauliac( #1)
Principal Investigator Name
Guillaume Taieb
Principal Investigator Email
g-taieb@chu-montpellier.fr
Contact Person Name
Guillaume Taieb
Contact Person Email
g-taieb@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurologie
Principal Investigator Name
Sabrina SACCONI
Principal Investigator Email
sacconi.s@chu-nice.fr
Contact Person Name
Sabrina SACCONI
Contact Person Email
sacconi.s@chu-nice.fr

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
code: 3
Name
PPD International Holdings LLC
Responsibilities
code: 4

Third parties

  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"World Courier France","duties_or_roles":"code: 15; Direct-to-Patient / Direct-from-Patient courier - IMP transportation","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
riliprubart
Active Substance
RILIPRUBART
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Orphan Designation
Yes
Maximum Dose
300 mg

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