Clinical trial • Phase III • Neurology

SAR441344 for Multiple sclerosis | Relapsing multiple sclerosis

Phase III trial of SAR441344 for Multiple sclerosis | Relapsing multiple sclerosis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Multiple sclerosis | Relapsing multiple sclerosis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
08-01-2024
First CTIS Authorization Date
26-04-2024

Trial design

Randomised, teriflunomide 14 mg once daily (active comparator); matching placebo arms (placebo described in product list).-controlled Phase III trial in Croatia, Denmark, France and others.

Randomised
Yes
Comparator
Teriflunomide 14 mg once daily (active comparator); matching placebo arms (placebo described in product list).
Target Sample Size
718

Eligibility

Recruits 718 Vulnerable population selected. Informed consent is handled via subject information and informed consent forms (L1) provided in multiple languages; partner pregnancy ICFs and addenda are available. Participants are adults; no assent process for minors is described in the record..

Vulnerable Population
Vulnerable population selected. Informed consent is handled via subject information and informed consent forms (L1) provided in multiple languages; partner pregnancy ICFs and addenda are available. Participants are adults; no assent process for minors is described in the record.

Inclusion criteria

  • {"criterion_text":"- The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria."}
  • {"criterion_text":"- The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)"}
  • {"criterion_text":"- The participant must have at least 1 of the following prior to screening: ◼ ≥1 documented relapse within the previous year OR ◼ ≥2 documented relapses within the previous 2 years, OR ◼ ≥1 documented Gd enhancing lesion on an MRI scan within the previous year."}
  • {"criterion_text":"- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}

Exclusion criteria

  • {"criterion_text":"- The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria"}
  • {"criterion_text":"- The participant has a history of infection or may be at risk for infection."}
  • {"criterion_text":"- The presence of psychiatric disturbance or substance abuse."}
  • {"criterion_text":"- History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment."}
  • {"criterion_text":"- Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia"}
  • {"criterion_text":"- A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren’s syndrome, acute disseminated encephalomyelitis, and myasthenia gravis."}
  • {"criterion_text":"- The participant has had a relapse in the 30 days prior to randomization."}
  • {"criterion_text":"- The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses","definition_or_measurement_approach":"Assessed by protocol-defined adjudicated relapses during the study period (as stated)."}

Secondary endpoints

  • {"endpoint_text":"- Time to onset of composite confirmed disability worsening (cCDW)","definition_or_measurement_approach":"Time to onset of cCDW (composite confirmed disability worsening) as defined in protocol."}
  • {"endpoint_text":"- Time to onset of cCDW, confirmed over 3 months","definition_or_measurement_approach":"Time to onset of cCDW confirmed over 3 months."}
  • {"endpoint_text":"- Time to onset of individual components of the composite, confirmed over 3-months or 6- months","definition_or_measurement_approach":"Time to onset of individual components of the composite endpoint, confirmed over 3 or 6 months."}
  • {"endpoint_text":"- Time to onset of confirmed disability improvement (CDI)","definition_or_measurement_approach":"Time to onset of confirmed disability improvement (CDI)."}
  • {"endpoint_text":"- Progression independent of relapse activity defined as the time to onset of 6-month cCDW","definition_or_measurement_approach":"Time to onset of 6-month cCDW representing progression independent of relapse activity."}
  • {"endpoint_text":"- Total number of new and/or enlarging T2-hyperintense lesions as detected by MRI","definition_or_measurement_approach":"Count of new and/or enlarging T2-hyperintense lesions detected by MRI."}
  • {"endpoint_text":"- Total number of new Gd-enhancing T1-hyperintense lesions per scan as detected by MRI","definition_or_measurement_approach":"Count of new Gadolinium-enhancing T1-hyperintense lesions per MRI scan."}
  • {"endpoint_text":"- Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6","definition_or_measurement_approach":"Percent change in brain volume loss on brain MRI scans at End of Study (EOS) compared to Month 6."}
  • {"endpoint_text":"- Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT)","definition_or_measurement_approach":"Change from baseline to EOS in cognitive function assessed by SDMT."}
  • {"endpoint_text":"- Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time","definition_or_measurement_approach":"Change from baseline over time in MSIS-29v2 patient-reported scores."}
  • {"endpoint_text":"- Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time","definition_or_measurement_approach":"Change from baseline over time in PROMIS Fatigue MS-8 scores."}
  • {"endpoint_text":"- Adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, safety scales, and potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG, and vital signs during the study period","definition_or_measurement_approach":"Safety assessments including AE/SAE reporting, AESIs, safety scales, and PCSAs in labs, ECG, and vital signs during study period."}
  • {"endpoint_text":"- Antidrug antibodies (ADAs) over time","definition_or_measurement_approach":"Measurement of anti-drug antibodies (ADA) longitudinally over time."}
  • {"endpoint_text":"- Change from baseline in plasma neurofilament light chain (NfL) levels over time","definition_or_measurement_approach":"Change from baseline in plasma NfL levels measured over time."}
  • {"endpoint_text":"- Frexalimab plasma concentration over time","definition_or_measurement_approach":"Measurement of frexalimab plasma concentration longitudinally over time."}

Recruitment

Digital Remote Recruitment
True, digital methods include digital marketing campaigns, landing pages, online self-assessment questionnaire and related digital materials (language-specific K2 documents listed).
Planned Sample Size
718
Recruitment Window Months
38
Consent Approach
Informed consent obtained from participants using subject information and informed consent forms (L1) provided in multiple language versions (documents available in English, Bulgarian, Portuguese, Croatian, Czech, Dutch, French, German, Greek, Hungarian, Italian, Lithuanian, Polish, Romanian, Slovak, Spanish and others). Partner pregnancy information/ICF and addenda are available. Participants are adults; consent provided by participant.

Methods

  • Digital marketing campaign content (K2 recruitment material documents present: digital marketing campaign content files for multiple countries)
  • Landing page (K2 recruitment material - landing page documents)
  • Posters (K2 recruitment material - poster files)
  • Patient brochure and patient guide (K2 recruitment material - patient brochure/guide files)
  • Doctor-to-doctor referral letters (K2 recruitment material - dr-to-dr / referral letters)
  • Self-assessment questionnaire (K2 recruitment material - self-assessment questionnaire)
  • Secondary assessment and communication process (K2 recruitment material - secondary assessment and communication)
  • Privacy/cookie policy for recruitment websites (K2 recruitment material - privacy-cookie-policy)
  • Site brochures and local site information materials

Geography

Total Number Of Sites
69
Total Number Of Participants
386

Croatia

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
30-04-2024
Processing Time Days
21
Number Of Sites
1
Number Of Participants
13

Sites

Site Name
University Hospital Centre Zagreb
Department Name
Department of Neurology
Principal Investigator Name
Mario Habek
Principal Investigator Email
mhabek@mef.hr
Contact Person Name
Mario Habek
Contact Person Email
mhabek@mef.hr

Denmark

Earliest CTIS Part Ii Submission Date
03-04-2024
Latest Decision Or Authorization Date
30-04-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Esbjerg Sygehus
Department Name
Neurologisk Afd.
Principal Investigator Name
Tobias Sejbaek
Principal Investigator Email
tobias.sejbaek@rsyd.dk
Contact Person Name
Tobias Sejbaek
Contact Person Email
tobias.sejbaek@rsyd.dk
Site Name
Rigshospitalet
Department Name
Neurologisk Afd. N
Principal Investigator Name
Jette FREDERIKSEN
Principal Investigator Email
jetfre01@glo.regionH.dk
Contact Person Name
Jette FREDERIKSEN
Contact Person Email
jetfre01@glo.regionH.dk

France

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
29-04-2024
Processing Time Days
31
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurologie
Principal Investigator Name
Christine LEBRUN FRENAY
Principal Investigator Email
lebrun.c@chu-nice.fr
Contact Person Name
Christine LEBRUN FRENAY
Contact Person Email
lebrun.c@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Clinique de Neurologie
Principal Investigator Name
Patrick VERMERSCH
Principal Investigator Email
patrick.vermersch@univ-lille2.fr
Contact Person Name
Patrick VERMERSCH
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Neurologie
Principal Investigator Name
David Laplaud
Principal Investigator Email
david.laplaud@chu-nantes.fr
Contact Person Name
David Laplaud
Contact Person Email
david.laplaud@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Neurology
Principal Investigator Name
Olivier Casez
Principal Investigator Email
OCasez@chu-grenoble.fr
Contact Person Name
Olivier Casez
Contact Person Email
OCasez@chu-grenoble.fr

Lithuania

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
30-04-2024
Processing Time Days
15
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Department Name
Department of Neurology
Principal Investigator Name
Natasa Giedraitiene
Principal Investigator Email
Natasa.Giedraitiene@santa.lt
Contact Person Name
Natasa Giedraitiene
Contact Person Email
Natasa.Giedraitiene@santa.lt

Bulgaria

Earliest CTIS Part Ii Submission Date
02-04-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
616
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Multiprofile Hospital For Active Treatment Blagoevgrad AD
Department Name
Department of Neurology Diseases
Principal Investigator Name
Spaska Georgieva-Zhostova
Principal Investigator Email
spacegeorgieva@abv.bg
Contact Person Name
Spaska Georgieva-Zhostova
Contact Person Email
spacegeorgieva@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Clinic of neurology
Principal Investigator Name
Maya Danovska-Mladenova
Principal Investigator Email
mdanovska@yahoo.com
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Department Name
Diagnostic Consultative Center Convex EOOD
Principal Investigator Name
Krasimir Genov
Principal Investigator Email
kr_genov@abv.bg
Contact Person Name
Krasimir Genov
Contact Person Email
kr_genov@abv.bg
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Clinic of Neurology and Sleep Medicine
Principal Investigator Name
Ivan Staikov
Principal Investigator Email
ivanstaikov@hotmail.com
Contact Person Name
Ivan Staikov
Contact Person Email
ivanstaikov@hotmail.com
Site Name
Multiprofile Hospital For Active Treatment Pazardzik AD
Department Name
Department of Neurology Diseases
Principal Investigator Name
Nikolay Sotirov
Principal Investigator Email
nzs5@abv.bg
Contact Person Name
Nikolay Sotirov
Contact Person Email
nzs5@abv.bg

Portugal

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
631
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Department Name
Serviço Neurologia
Principal Investigator Name
Angela Silva
Principal Investigator Email
2112@hospitaldeguimaraes.min-saude.pt
Contact Person Name
Angela Silva
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço Neurologia
Principal Investigator Name
Joao Cerqueira
Principal Investigator Email
jcerqueira@med.uminho.pt
Contact Person Name
Joao Cerqueira
Contact Person Email
jcerqueira@med.uminho.pt
Site Name
Hospital Pedro Hispano
Department Name
Serviço Neurologia
Principal Investigator Name
Filipe Correia
Principal Investigator Email
filipemajo@gmail.com
Contact Person Name
Filipe Correia
Contact Person Email
filipemajo@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
620
Number Of Sites
6
Number Of Participants
63

Sites

Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Principal Investigator Name
Halina Bartosik-Psujek
Principal Investigator Email
badania.kliniczne.medyk@gmail.com
Contact Person Name
Halina Bartosik-Psujek
Site Name
Neuro-Medic Sp. z o.o.
Principal Investigator Name
Janusz Zbrojkiewicz
Principal Investigator Email
jzbrojkiewicz@op.pl
Contact Person Name
Janusz Zbrojkiewicz
Contact Person Email
jzbrojkiewicz@op.pl
Site Name
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
Principal Investigator Name
Jutyna Hryniewicz
Principal Investigator Email
j.dhryniewicz@gmail.com
Contact Person Name
Jutyna Hryniewicz
Contact Person Email
j.dhryniewicz@gmail.com
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Principal Investigator Name
Robert Bonek
Principal Investigator Email
bonek.robert@gmail.com
Contact Person Name
Robert Bonek
Contact Person Email
bonek.robert@gmail.com
Site Name
Neurokard Sp. z o.o.
Department Name
ProNeuro Centrum Medyczne
Principal Investigator Name
Maciej Swiat
Principal Investigator Email
biuro@proneuro.pl
Contact Person Name
Maciej Swiat
Contact Person Email
biuro@proneuro.pl
Site Name
Wielospecjalistyczne Centrum Medyczne IBISMED S.C
Principal Investigator Name
Monika Adamczyk-Sowa
Principal Investigator Email
cm@ibismed.pl
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
cm@ibismed.pl

Austria

Earliest CTIS Part Ii Submission Date
03-04-2024
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
611
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
University Hospital for Neurology
Principal Investigator Name
Florian Deisenhammer
Principal Investigator Email
florian.deisenhammer@tirol-kliniken.at
Contact Person Name
Florian Deisenhammer

Spain

Earliest CTIS Part Ii Submission Date
03-04-2024
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
616
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Departamento de Neurología
Principal Investigator Name
Celia Oreja-Guevara
Principal Investigator Email
investigacion.clinico@gmail.com
Contact Person Name
Celia Oreja-Guevara
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Departamento de Neurología
Principal Investigator Name
Rafael Arroyo
Principal Investigator Email
rafaelarroyo09@gmail.com
Contact Person Name
Rafael Arroyo
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Departamento de Neurología
Principal Investigator Name
Jose Meca Lallana
Principal Investigator Email
pmecal@gmail.com
Contact Person Name
Jose Meca Lallana
Contact Person Email
pmecal@gmail.com
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Departamento de Neurología
Principal Investigator Name
Santiago Diaz Nicolas
Principal Investigator Email
sdianic80@gmail.com
Contact Person Name
Santiago Diaz Nicolas
Contact Person Email
sdianic80@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Departamento de Neurología
Principal Investigator Name
Sara Eichau Madueno
Principal Investigator Email
saraeichau@gmail.com
Contact Person Name
Sara Eichau Madueno
Contact Person Email
saraeichau@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Departamento de Neurología
Principal Investigator Name
Lucienne Costa-Frossard Franca
Principal Investigator Email
lufrossard@yahoo.es
Contact Person Name
Lucienne Costa-Frossard Franca
Contact Person Email
lufrossard@yahoo.es
Site Name
Hospital Universitario De La Princesa
Department Name
Departamento de Neurología
Principal Investigator Name
Virginia Meca
Principal Investigator Email
virmeca@hotmail.com
Contact Person Name
Virginia Meca
Contact Person Email
virmeca@hotmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Departamento de Neurología
Principal Investigator Name
Eduardo Aguera-Morales
Principal Investigator Email
doctoredu@gmail.com
Contact Person Name
Eduardo Aguera-Morales
Contact Person Email
doctoredu@gmail.com
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Departamento de Neurología
Principal Investigator Name
Nieves Tellez
Principal Investigator Email
tellezlara@gmail.com
Contact Person Name
Nieves Tellez
Contact Person Email
tellezlara@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Departamento de Neurología
Principal Investigator Name
Ana Alonso
Principal Investigator Email
a.alonso.eecc@gmail.com
Contact Person Name
Ana Alonso
Contact Person Email
a.alonso.eecc@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Departamento de Neurología
Principal Investigator Name
Xavier Montalban
Principal Investigator Email
xavier.montalban@cem-cat.org
Contact Person Name
Xavier Montalban
Contact Person Email
xavier.montalban@cem-cat.org
Site Name
Hospital Clinico Universitario De Valladolid (duplicate listing consolidated)
Department Name
Departamento de Neurología
Principal Investigator Name
Nieves Tellez
Principal Investigator Email
tellezlara@gmail.com
Contact Person Name
Nieves Tellez
Contact Person Email
tellezlara@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
03-04-2024
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
611
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Noorderhart
Department Name
Revalidatie en MS centrum
Principal Investigator Name
Bart Van Wijmeersch
Principal Investigator Email
bart.vanwijmeersch@uhasselt.be
Contact Person Name
Bart Van Wijmeersch
Contact Person Email
bart.vanwijmeersch@uhasselt.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Neurology
Principal Investigator Name
Guy Laureys
Principal Investigator Email
guy.laureys@uzgent.be
Contact Person Name
Guy Laureys
Contact Person Email
guy.laureys@uzgent.be

Hungary

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
644
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Neurologiai Osztaly
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
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Neurologiai Osztaly
Principal Investigator Name
Istvan Deme
Principal Investigator Email
deme.istvan@kmmk.hu
Contact Person Name
Istvan Deme
Contact Person Email
deme.istvan@kmmk.hu

Greece

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
679
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University General Hospital Of Ioannina
Department Name
Neurology Clinic, University Hosp of Ioannina
Principal Investigator Name
Spyridon Konitsiotis
Principal Investigator Email
skonitso@uoi.gr
Contact Person Name
Spyridon Konitsiotis
Contact Person Email
skonitso@uoi.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
B' Neurology clinic, AHEPA General Hospital of Thessaloniki
Principal Investigator Name
Nikolaos GRIGORIADIS
Principal Investigator Email
grigoria@med.auth.gr
Contact Person Name
Nikolaos GRIGORIADIS
Contact Person Email
grigoria@med.auth.gr

Romania

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
684
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Clubul Sanatatii S.R.L.
Department Name
Neurologie
Principal Investigator Name
Emilian Manescu
Principal Investigator Email
silviumanescu@yahoo.com
Contact Person Name
Emilian Manescu
Contact Person Email
silviumanescu@yahoo.com

Slovakia

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
616
Number Of Sites
3
Number Of Participants
19

Sites

Site Name
Fakultna Nemocnica Nitra
Department Name
Neurologicka klinika
Principal Investigator Name
Slavomira Kovacova
Principal Investigator Email
slavomira.kovacova@fnnitra.sk
Contact Person Name
Slavomira Kovacova
Contact Person Email
slavomira.kovacova@fnnitra.sk
Site Name
Univerzitna Nemocnica Martin
Department Name
Neurologicka klinika
Principal Investigator Name
Ema Kantorova
Principal Investigator Email
ema.kantorova@uniba.sk
Contact Person Name
Ema Kantorova
Contact Person Email
ema.kantorova@uniba.sk
Site Name
Fakultna Nemocnica Trnava
Department Name
Neurologicke oddelenie
Principal Investigator Name
Georgi Krastev
Principal Investigator Email
georgi.krastev@fntt.sk
Contact Person Name
Georgi Krastev
Contact Person Email
georgi.krastev@fntt.sk

Italy

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
624
Number Of Sites
13
Number Of Participants
25

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Clinica Neurologica
Principal Investigator Name
Maura Frigo
Principal Investigator Email
frimau05@gmail.com
Contact Person Name
Maura Frigo
Contact Person Email
frimau05@gmail.com
Site Name
San Camillo Forlanini Hospital
Department Name
Neurologia
Principal Investigator Name
Claudio Gasperini
Principal Investigator Email
cgasperini@scamilloforlanini.rm.it
Contact Person Name
Claudio Gasperini
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Dipartimento di neurologia
Principal Investigator Name
Giuseppe Salemi
Principal Investigator Email
giuseppe.salemi@unipa.it
Contact Person Name
Giuseppe Salemi
Contact Person Email
giuseppe.salemi@unipa.it
Site Name
Careggi University Hospital
Department Name
Dip Neuroscienze, Psicologia, Farmaco e Salute Bambino (NEUROFARBA) SOD Riab Neurologica
Principal Investigator Name
Maria Amato
Principal Investigator Email
mariapia.amato@unifi.it
Contact Person Name
Maria Amato
Contact Person Email
mariapia.amato@unifi.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Dipartimento di neurologia
Principal Investigator Name
Girolama Marfia
Principal Investigator Email
marfia@uniroma2.it
Contact Person Name
Girolama Marfia
Contact Person Email
marfia@uniroma2.it
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 Foundation Istituto Neurologico Carlo Besta
Department Name
IRCCS Istituto Neurologico Carlo Besta
Principal Investigator Name
Sebastiano Crisafulli
Principal Investigator Email
sebastiano.crisafulli@istituto-besta.it
Contact Person Name
Sebastiano Crisafulli
Site Name
Universita' Degli Studi G. D'annunzio Di Chieti
Department Name
Neurologia
Principal Investigator Name
Valentina Tomassini
Principal Investigator Email
valentina.tomassini@unich.it
Contact Person Name
Valentina Tomassini
Contact Person Email
valentina.tomassini@unich.it
Site Name
Congregazione Delle Suore Infermiere Dell'Addolorata
Department Name
U.O.C di Neurologia
Principal Investigator Name
Francesca Sangalli
Principal Investigator Email
fsangalli@valduce.it
Contact Person Name
Francesca Sangalli
Contact Person Email
fsangalli@valduce.it
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Dipartimento di neurologia
Principal Investigator Name
Diego Centonze
Principal Investigator Email
centonze@uniroma2.it
Contact Person Name
Diego Centonze
Contact Person Email
centonze@uniroma2.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neurologia
Principal Investigator Name
Massimiliano Mirabella
Contact Person Name
Massimiliano Mirabella
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Centro Sclerosi Multipla
Principal Investigator Name
Emanuele D'Amico
Principal Investigator Email
emanuele.damico@unifg.it
Contact Person Name
Emanuele D'Amico
Contact Person Email
emanuele.damico@unifg.it
Site Name
Azienda Ospedaliera Universitaria Integrata Di Verona
Department Name
Dipartimento di neurologia
Principal Investigator Name
Massimiliano Calabrese
Principal Investigator Email
massimiliano.calabrese@univr.it
Contact Person Name
Massimiliano Calabrese

Netherlands

Earliest CTIS Part Ii Submission Date
02-04-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
611
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Academisch MS Centrum Zuyderland
Principal Investigator Name
Stephanie Knippenberg
Principal Investigator Email
s.knippenberg@zuyderland.nl
Contact Person Name
Stephanie Knippenberg
Contact Person Email
s.knippenberg@zuyderland.nl

Czechia

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
10-01-2026
Processing Time Days
635
Number Of Sites
5
Number Of Participants
68

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologicka klinika
Principal Investigator Name
Zbysek Pavelek
Principal Investigator Email
zbysek.pavelek@fnhk.cz
Contact Person Name
Zbysek Pavelek
Contact Person Email
zbysek.pavelek@fnhk.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. neurologicka klinika
Principal Investigator Name
Michal Dufek
Principal Investigator Email
michal.dufek@fnusa.cz
Contact Person Name
Michal Dufek
Contact Person Email
michal.dufek@fnusa.cz
Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Neurologicke oddeleni
Principal Investigator Name
Eva Recmanova
Principal Investigator Email
eva.recmanova@bnzlin.cz
Contact Person Name
Eva Recmanova
Contact Person Email
eva.recmanova@bnzlin.cz
Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
Neurologicke oddeleni
Principal Investigator Name
Radek Ampapa
Principal Investigator Email
ampapar@nemji.cz
Contact Person Name
Radek Ampapa
Contact Person Email
ampapar@nemji.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurologicka klinika
Principal Investigator Name
Miroslav Mares
Principal Investigator Email
miroslav.mares@nempk.cz
Contact Person Name
Miroslav Mares
Contact Person Email
miroslav.mares@nempk.cz

Germany

Earliest CTIS Part Ii Submission Date
03-04-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
747
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Technische Universitaet Dresden
Department Name
Neurology
Principal Investigator Name
Ziemssen Tjalf
Principal Investigator Email
tjalf.Ziemssen@ukdd.de
Contact Person Name
Ziemssen Tjalf
Contact Person Email
tjalf.Ziemssen@ukdd.de
Site Name
Universitaet Leipzig
Department Name
Neurologie
Principal Investigator Name
Florian Then Bergh
Principal Investigator Email
florian.thenbergh@medizin.uni-leipzig.de
Contact Person Name
Florian Then Bergh
Site Name
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
Department Name
Nervenarztliche Gemeinschaftspraxis
Principal Investigator Name
Daniela Rau
Principal Investigator Email
rau@neurologie-ulm.de
Contact Person Name
Daniela Rau
Contact Person Email
rau@neurologie-ulm.de
Site Name
St. Josef-Hospital
Department Name
Klinik für Neurologie
Principal Investigator Name
Simon Faissner
Principal Investigator Email
simon.faissner@rub.de
Contact Person Name
Simon Faissner
Contact Person Email
simon.faissner@rub.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Neurologie
Principal Investigator Name
Orhan Aktas
Principal Investigator Email
orhan.aktas@med.uni-duesseldorf.de
Contact Person Name
Orhan Aktas

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Home Health Care / Nursing (sponsorDuties code 15)
Name
Endpoint Clinical Inc.
Responsibilities
Sponsor duties code 3 (as listed)
Name
Bioclinica S.A.
Responsibilities
Sponsor duties code 4 (as listed)
Name
Eresearchtechnology Inc.
Responsibilities
Sponsor duties code 7 (as listed)
Name
Labcorp Central Laboratory Services LP
Responsibilities
Laboratory services (sponsorDuties code 4)

Third parties

  • {"country":"Romania","full_name":"Medimar Imagistic Services S.R.L.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Hiperdia S.A.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Romania","full_name":"Bioclinica S.A.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"sponsorDuties: Central Medical Reading or Imaging Reading (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Affidea Romania S.R.L.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"sponsorDuties codes: [15] value: Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [15] value: Home Health Care / Nursing","organisation_type":"Pharmaceutical company"}
  • {"country":"Portugal","full_name":"Evidenze Portugal Unipessoal Lda.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Marken","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
frexalimab (SAR441344)
Active Substance
SAR441344
Modality
Monoclonal antibody
Authorisation Status
Not authorised (prodAuthStatus: 1)
Investigational Product Name
Teriflunomide (comparator, e.g., Aubagio)
Active Substance
Teriflunomide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/13/838/001; prodAuthStatus: 2)
Starting Dose
14 mg (daily comparator dose stated in main objective)
Frequency
Once daily

Related trials

Other published trials that may interest you.