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

RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)

Phase III trial of RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP).

Overview

Trial Therapeutic Area
Immunology|Neurology|Rare Disease
Trial Disease
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Other antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
22-03-2024
First CTIS Authorization Date
15-07-2024

Trial design

Randomised, open-label, intravenous immunoglobulin (ivig) continuation; maintenance dosing regimen per ean/pns 2021: 0.4 to 1 g/kg every 2 to 6 weeks (equivalent or higher than a weekly dose of 0.1 g/kg body weight; e.g., 0.3 g/kg every 3 weeks).-controlled Phase III trial in Denmark, Belgium, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Intravenous immunoglobulin (IVIg) continuation; maintenance dosing regimen per EAN/PNS 2021: 0.4 to 1 g/kg every 2 to 6 weeks (equivalent or higher than a weekly dose of 0.1 g/kg body weight; e.g., 0.3 g/kg every 3 weeks).
Target Sample Size
142
Trial Duration For Participant
336

Eligibility

Recruits 142 No vulnerable populations selected. Informed consent is obtained using subject information and informed consent forms (L1-sis-icf and related documents). Partner/pregnancy and caregiver information forms are included; consent documents are provided in multiple language versions..

Pregnancy Exclusion
Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.
Vulnerable Population
No vulnerable populations selected. Informed consent is obtained using subject information and informed consent forms (L1-sis-icf and related documents). Partner/pregnancy and caregiver information forms are included; consent documents are provided in multiple language versions.

Inclusion criteria

  • {"criterion_text":"-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).\n-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).\n-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.\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.\n-Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n-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.\n-All participants must agree to use contraception methods during and after the study as required.\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.\n--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: -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.\n--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), preferably with low user dependency, 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.\n-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.\n-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.\n-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.\n-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)."}

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 IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\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.\n-Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n-Sensory CIDP, distal CIDP and focal CIDP variants.\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: --HBsAg. --Anti-HBc Ab; unless anti-HBs Ab are also positive, indicating natural immunity. --Anti-HCV antibodies. --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; imprisoned or legally institutionalized.\n-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.\n-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.\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 the C-SSRS during Screening, OR if in the Investigator’s judgment, the participant is at risk for a suicide attempt.\n-Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\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, 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 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).\n-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.\n-Treatment with efgartigimod within 8 weeks prior to screening.\n-Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n-Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n-Treatment with plasma exchange within 8 weeks prior to Screening.\n-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).\n-Prior treatment with riliprubart.\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-Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants experiencing a response","definition_or_measurement_approach":"Response assessed per protocol; main objectives indicate efficacy measured by the INCAT disability scale (INCAT)."}
  • {"endpoint_text":"- Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period.","definition_or_measurement_approach":"Response during Part A and durability during the open-label extension assessed per protocol; INCAT disability scale referenced in main objectives."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score","definition_or_measurement_approach":"Change from baseline in I-RODS score (continuous measure)."}
  • {"endpoint_text":"- Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score","definition_or_measurement_approach":"Change from baseline in adjusted INCAT disability score."}
  • {"endpoint_text":"- Change from baseline in grip strength (kilopascals, dominant hand)","definition_or_measurement_approach":"Change from baseline in grip strength (kPa) measured in dominant hand."}
  • {"endpoint_text":"- Change from baseline in Medical Research Council Sum Score (MRC-SS)","definition_or_measurement_approach":"Change from baseline in MRC-SS (muscle strength sum score)."}
  • {"endpoint_text":"- Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)","definition_or_measurement_approach":"Change from baseline in RT-FSS (fatigue severity score)."}
  • {"endpoint_text":"- Percentage of participants experiencing a relapse","definition_or_measurement_approach":"Proportion of participants meeting relapse definition per protocol."}
  • {"endpoint_text":"- Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)","definition_or_measurement_approach":"Change from baseline in EQ-5D-5L health status score."}
  • {"endpoint_text":"- Number of participants with TEAEs, including SAEs and AESIs for Part A.","definition_or_measurement_approach":"Count and categorization of treatment-emergent adverse events, serious adverse events and adverse events of special interest during Part A."}
  • {"endpoint_text":"- Number of participants with treatment-emergent ADA in participants treated with riliprubart","definition_or_measurement_approach":"Incidence (count) of treatment-emergent anti-drug antibodies (ADA) in riliprubart-treated participants."}
  • {"endpoint_text":"- Number of participants with TEAEs, including SAEs and AESIs","definition_or_measurement_approach":"Count of TEAEs, SAEs and AESIs across study periods."}
  • {"endpoint_text":"- Percentage of participants randomized to riliprubart experiencing a relapse","definition_or_measurement_approach":"Proportion of riliprubart-randomized participants meeting protocol-defined relapse criteria."}
  • {"endpoint_text":"- Percentage of participants randomized to IVIg continuation experiencing a relapse","definition_or_measurement_approach":"Proportion of IVIg-continuation participants meeting protocol-defined relapse criteria."}
  • {"endpoint_text":"- Incidence and titer of anti-drug antibodies (ADA) during open-label treatment and follow-up.","definition_or_measurement_approach":"Incidence and titers of ADA measured during open-label treatment and follow-up per immunogenicity assay."}
  • {"endpoint_text":"- Change from baseline in I-RODS","definition_or_measurement_approach":"Change from baseline in I-RODS score (repeated measure)."}
  • {"endpoint_text":"- Change from baseline in adjusted INCAT score","definition_or_measurement_approach":"Change from baseline in adjusted INCAT score."}
  • {"endpoint_text":"- Change from baseline in grip strength (kilopascals; dominant hand)","definition_or_measurement_approach":"Change from baseline in grip strength (kPa) measured in dominant hand."}
  • {"endpoint_text":"- Change from baseline in MRC-SS","definition_or_measurement_approach":"Change from baseline in Medical Research Council Sum Score."}
  • {"endpoint_text":"- Change from baseline in RT-FSS","definition_or_measurement_approach":"Change from baseline in Rasch-built fatigue severity scale (RT-FSS)."}
  • {"endpoint_text":"- Change from baseline in EQ-5D-5L score","definition_or_measurement_approach":"Change from baseline in EQ-5D-5L score."}
  • {"endpoint_text":"- Percentage of participants randomized to riliprubart who experienced a response at Week 48 without prior response in Part A (delayed response)","definition_or_measurement_approach":"Proportion meeting response at Week 48 without prior Part A response (delayed response) per protocol."}
  • {"endpoint_text":"- Percentage of participants randomized to IVIg continuation who experience a response","definition_or_measurement_approach":"Proportion of IVIg-continuation participants experiencing a response per protocol."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
142
Recruitment Window Months
34
Consent Approach
Written informed consent is obtained using subject information and informed consent forms (L1-sis-icf and related documents). Consent and participant information materials are provided in multiple language versions (English and local language ICFs for participating countries). Partner/pregnancy forms and caregiver information forms are available; contraception requirements and agreements are included in consent materials.

Methods

  • Posters and printed trifold flyers (site materials) — country-specific versions present (examples: it, fr, de, es, hu, pt, pl, sv, nl, da, el, cs).
  • Social media posts and captions (digital awareness) — social-media-post and social-media-post-captions documents present for multiple countries.
  • HCP (healthcare professional) letters / referral letters sent to treating clinicians (HCP-letter documents).
  • Participant letters and email templates for direct contact (participant-letter, email-template documents).
  • Prescreener materials and flipcharts for site screening visits (prescreener, flipchart documents).
  • Website / Sanofi-studies webpages and digital awareness documents.
  • Infographics and QR-code-enabled flyers for digital signposting.

Geography

Total Number Of Sites
65
Total Number Of Participants
113

Denmark

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
26
Number Of Sites
2
Number Of Participants
6

Sites

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

Belgium

Earliest CTIS Part Ii Submission Date
18-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
34
Number Of Sites
2
Number Of Participants
6

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

Italy

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
77
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Malattie Neuromuscolari e Neuroimmunologia IRCCS
Contact Person Name
Pietro Doneddu
Contact Person Email
pietro.doneddu@hunimed.eu
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Neurologia
Contact Person Name
Stefano Previtali
Contact Person Email
previtali.stefano@hsr.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Neurologia
Contact Person Name
Nilo Riva
Contact Person Email
nilo.riva@istituto-besta.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UOC clinica nurologica
Contact Person Name
Vincenzo Donadio
Contact Person Email
vincenzo.donadio@unibo.it
Site Name
Azienda Ospedaliera di Padova
Department Name
dipartimento di Neuroscienze
Contact Person Name
Chiara Briani
Contact Person Email
chiara.briani@unipd.it

Sweden

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
30
Number Of Sites
1
Number Of Participants
3

Sites

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

France

Earliest CTIS Part Ii Submission Date
18-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
29
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Departement de neurologie
Contact Person Name
Rabab Debs
Contact Person Email
rabab.debs@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurologie
Contact Person Name
Sabrina SACCONI
Contact Person Email
sacconi.s@chu-nice.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de Neurologie
Contact Person Name
Shahram Attarian
Contact Person Email
shahram.attarian@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie
Contact Person Name
Andoni Echaniz-Laguna
Contact Person Email
andoni.echaniz-laguna@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
CHRU Lille - Hopital Roger Salengro
Contact Person Name
Celine Tard
Contact Person Email
celine.tard@chu-lille.fr

Greece

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
89
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Department of Neurology
Contact Person Name
Vasilios Kimiskidis
Contact Person Email
kimiskid@auth.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Department of Neurology clinic
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr

Poland

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
10
Number Of Sites
2
Number Of Participants
6

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
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Contact Person Name
Konrad Rejdak
Contact Person Email
rejdakk@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
30
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Nevrologisk avdeling
Contact Person Name
Angelina Hatlø Maniaol
Contact Person Email
ANGMAN@ous-hf.no

Czechia

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
14
Number Of Sites
5
Number Of Participants
16

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
Fakultni Nemocnice Brno
Department Name
Neurologicka klinika
Contact Person Name
Josef Bednarik
Contact Person Email
bednarik.josef@fnbrno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologicka klinika
Contact Person Name
Michaela Tyblova
Contact Person Email
michaela.tyblova@vfn.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Neurologicka klinika
Contact Person Name
Jana Junkerova
Contact Person Email
jana.junkerova@fno.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurologicka klinika
Contact Person Name
Edvard EHLER
Contact Person Email
edvard.ehler@nempk.cz

Spain

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
4
Number Of Sites
10
Number Of Participants
10

Sites

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 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 Universitario Regional De Malaga
Department Name
Hospital Regional Universitario de Malaga( #1)
Contact Person Name
Virginia Reyes Garrido
Contact Person Email
v.reyes.eecc@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Hospital de Sabadell - Corporacio Sanitaria Parc Tauli( #1)
Contact Person Name
Jordi Espinosa Garcia
Contact Person Email
jespinosa@tauli.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hospital Universitari Vall D Hebron
Contact Person Name
Raul Juntas-Morales
Contact Person Email
raul.juntas@vallhebron.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 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
Complexo Hospitalario Universitario De Santiago
Department Name
Hospital Clínico Universitario de Santiago
Contact Person Name
Beatrice Canneti
Contact Person Email
canneti.heredia@gmail.com
Site Name
Hospital Universitario Nuestra Senora De Candelaria
Department Name
Hospital Universitario Nuestra Señora de la Candelaria
Contact Person Name
Jorge Alonso Perez

Hungary

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
22
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Semmelweis University
Department Name
Neurologiai Klinika
Contact Person Name
Magdolna Simo
Contact Person Email
simomagdi@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Neurologiai Osztaly
Contact Person Name
Attila Csanyi
Contact Person Email
csanyia@petz.gyor.hu
Site Name
Eszak-Budai Szent Janos Centrumkorhaz
Department Name
Neurológiai osztály – stroke centrum
Contact Person Name
Fazekas Ferenc
Contact Person Email
fazekas.ferenc@janoskorhaz.hu
Site Name
University Of Szeged
Department Name
Neurologiai Klinika
Contact Person Name
Peter Klivenyi
Contact Person Email
klivenyi.peter@med.u-szeged.hu

Portugal

Earliest CTIS Part Ii Submission Date
26-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
20
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Unidade Local De Saude Lisboa Ocidental E.P.E.
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
CCAB Centro Clinico Academico Braga Associacao
Contact Person Name
Ricardo Mare
Contact Person Email
ricardo.mare@gmail.com
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Contact Person Name
Marisa Tavares Brum
Contact Person Email
marisatbrum@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Neurology
Contact Person Name
Mamede Alves de Carvalho
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Contact Person Name
Luciano Almendra
Contact Person Email
10365@ulscoimbra.min-saude.pt

Germany

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
21
Number Of Sites
20
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Neurologische Universitätsklinik
Contact Person Name
Mark Stettner
Contact Person Email
mark.stettner@uk-essen.de
Site Name
Neurologisches Facharztzentrum Berlin
Department Name
Neurologisches Facharztzentrum Berlin( #1)
Contact Person Name
Klaus Tiel-Wilck
Contact Person Email
dr.tiel-wilck@nfzb.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charite Universitaetsmedizin Berlin (#1)
Contact Person Name
Frauke Stascheit
Contact Person Email
frauke.stascheit@charite.de
Site Name
Medizinische Hochschule Hannover
Department Name
Neurologische Klinik
Contact Person Name
Tobias Hegelmaier
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Klinik für Neurologie
Contact Person Name
Anna Lena Fisse
Contact Person Email
anna.fisse@rub.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Neurologie
Contact Person Name
Fatma Merzou
Contact Person Email
Fatma.Merzou@uks.eu
Site Name
Universitaetsmedizin Goettingen
Department Name
j.zschuentzsch@med.uni-goettingen.de
Contact Person Name
Jana Zschuentzsch
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Klinik für Neurologie
Contact Person Name
Thomas Duning
Site Name
Universitaet Muenster
Department Name
Universitatsklinikum Munster( #1)
Contact Person Name
Gerd MEYER ZU HORSTE

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
clinical data systems / clinical trial support (sponsor duties code 3)
Name
Pharmaceutical Product Development LLC
Responsibilities
CRO services (sponsor duties code 4)
Name
Eresearchtechnology Inc.
Responsibilities
Electronic data capture / eCOA provider (sponsor duties code 7)

Third parties

  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
riliprubart (IV infusion)
Active Substance
RILIPRUBART
Modality
Peptide/protein/enzyme
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Investigational (MIA M19/001)
Orphan Designation
Yes
Maximum Dose
50 mg/kg
Investigational Product Name
riliprubart (solution for injection in pre-filled pen; subcutaneous)
Active Substance
RILIPRUBART
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Investigational (MIA M19/001)
Orphan Designation
Yes
Maximum Dose
600 mg (max daily amount as listed)
Investigational Product Name
Intravenous immunoglobulin (IVIg) - comparator
Active Substance
Human immunoglobulins (IVIg)
Modality
Other antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Frequency
Maintenance dosing per local standard (0.4–1 g/kg every 2–6 weeks as per inclusion criteria)
Investigational Product Name
riliprubart placebo solution for injection in prefilled pen
Modality
Other
Authorisation Status
MIA M19/001 (placebo matched to riliprubart)
Investigational Product Name
placebo matching IVIg
Modality
Other
Routes Of Administration
IV INFUSION
Route
IV INFUSION

Related trials

Other published trials that may interest you.