Clinical trial • Phase III • Neurology

FREXALIMAB for Multiple sclerosis

Phase III trial of FREXALIMAB for Multiple sclerosis.

Overview

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

Key dates

Initial CTIS Submission Date
08-07-2024
First CTIS Authorization Date
22-10-2024

Trial design

Randomised, aubagio (teriflunomide) 14 mg orally once daily; matched placebo for comparator teriflunomide-controlled Phase III trial in Bulgaria, Denmark, Hungary and others.

Randomised
Yes
Comparator
AUBAGIO (teriflunomide) 14 mg orally once daily; matched placebo for comparator teriflunomide
Target Sample Size
660

Eligibility

Recruits 660 adults.

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: \t≥1 documented relapse within the previous year OR \t≥2 documented relapses within the previous 2 years, OR \t≥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"}

Secondary endpoints

  • {"endpoint_text":"- Time to onset of composite confirmed disability worsening (cCDW)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to onset of cCDW, confirmed over 3 months","definition_or_measurement_approach":"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":"Confirmed over 3 or 6 months as specified"}
  • {"endpoint_text":"- Time to onset of confirmed disability improvement (CDI)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression independent of relapse activity defined as the time to onset of 6-month cCDW","definition_or_measurement_approach":"Defined as time to onset of 6-month composite confirmed disability worsening (cCDW)"}
  • {"endpoint_text":"- Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI","definition_or_measurement_approach":"Detected and counted on brain MRI scans (T2-weighted sequences)"}
  • {"endpoint_text":"- Total number of new Gd-enhancing T1 hyperintense lesions per scan as detected by MRI","definition_or_measurement_approach":"Detected and counted on brain MRI scans with gadolinium enhancement (T1-weighted sequences)"}
  • {"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 measured by brain MRI at end of study (EOS) vs 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":"Assessed using the Symbol Digit Modalities Test (SDMT)"}
  • {"endpoint_text":"- Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time","definition_or_measurement_approach":"Patient-reported outcomes measured by the MSIS-29v2 questionnaire"}
  • {"endpoint_text":"- Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time","definition_or_measurement_approach":"Patient-reported fatigue measured using PROMIS Fatigue MS-8 instrument"}
  • {"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 monitoring of AEs, SAEs, AESIs, discontinuations, and potentially clinically significant abnormalities in labs, ECGs and vitals"}
  • {"endpoint_text":"- Antidrug antibodies (ADAs) over time","definition_or_measurement_approach":"Measurement of anti-drug antibodies in plasma/serum over time"}
  • {"endpoint_text":"- Change from baseline in plasma neurofilament light chain (NfL) levels over time","definition_or_measurement_approach":"Plasma NfL concentration changes from baseline measured over time"}
  • {"endpoint_text":"- Frexalimab plasma concentration over time","definition_or_measurement_approach":"Pharmacokinetic measurement of frexalimab plasma concentrations over time"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
660
Recruitment Window Months
32
Consent Approach
Informed consent is obtained from adult participants. Subject information sheets and informed consent forms (L1-sis-icf and related documents) are provided in multiple languages (English, Spanish, French, German, Italian, Portuguese, Polish, Czech, Hungarian, Lithuanian, Romanian, Greek, Croatian, Slovak, Bulgarian, Danish and others as per document list). There are also partner/pregnancy information and optional procedure/addendum consent documents available by language.

Methods

  • Digital marketing campaigns — documents titled 'digital-marketing-campaign-content' and 'landing-page' indicate use of online/digital channels and landing pages to reach potential participants (patient-targeted).
  • Doctor-to-doctor (dr-to-dr) referral materials — documents titled 'dr-to-dr' indicate referral letters/materials for HCP-to-HCP recruitment.
  • Printed materials and on-site materials — posters and patient brochures ('poster', 'patient-brochure', 'patient-guide') for clinic/hospital distribution.
  • Self-assessment questionnaire — documents titled 'self-assessment-questionnaire' to allow initial screening of potential participants.
  • Country/language-specific recruitment materials — multiple language versions of recruitment materials (en, es, de, fr, it, pt, pl, lt, hu, ro, sk, hr, cs, da, bg, etc.) indicate localization by country/language.

Geography

Total Number Of Sites
74
Total Number Of Participants
410

Bulgaria

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
11
Number Of Sites
5
Number Of Participants
26

Sites

Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Department of General Neurology at the Clinic of Nervous Diseases
Principal Investigator Name
Mariya Dimitrova
Principal Investigator Email
dr.m.i.dimitrova@gmail.com
Contact Person Name
Mariya Dimitrova
Contact Person Email
dr.m.i.dimitrova@gmail.com
Site Name
Multiprofile Hospital For Active Treatment Avis Medika OOD
Department Name
Department of Nervous Disease
Principal Investigator Name
Hristo LILOVSKI
Principal Investigator Email
hristolilovski@gmail.com
Contact Person Name
Hristo LILOVSKI
Contact Person Email
hristolilovski@gmail.com
Site Name
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
Department Name
Neurology Department
Principal Investigator Name
Tsocho Kmetski
Principal Investigator Email
ts.kmetski@gmail.com
Contact Person Name
Tsocho Kmetski
Contact Person Email
ts.kmetski@gmail.com
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Department of Multiple Sclerosis
Principal Investigator Name
Ivan MILANOV
Principal Investigator Email
acad_prof_ivan_milanov@yahoo.com
Contact Person Name
Ivan MILANOV
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Neurology Diseases
Principal Investigator Name
Penko Shotekov
Principal Investigator Email
shotekov@abv.bg
Contact Person Name
Penko Shotekov
Contact Person Email
shotekov@abv.bg

Denmark

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Esbjerg Og Grindsted 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

Hungary

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
42
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Clinexpert Kft.
Department Name
Clinexpert Gyógycentrum (#1)
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
University Of Pecs
Department Name
Klinikai Kozpont, Neurologiai Klinika
Principal Investigator Name
Peter Acs
Principal Investigator Email
acs.peter@pte.hu
Contact Person Name
Peter Acs
Contact Person Email
acs.peter@pte.hu
Site Name
S-Medicon Kft.
Department Name
S-Medicon Egeszsegugyi Szolgaltato Kft.
Principal Investigator Name
Maria SATORI
Principal Investigator Email
satori.maria@gmail.com
Contact Person Name
Maria SATORI
Contact Person Email
satori.maria@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
24-07-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
91
Number Of Sites
8
Number Of Participants
48

Sites

Site Name
Hospital Del Mar
Department Name
Departamento de Neurología
Principal Investigator Name
Jose Enrique Martinez Rodriguez
Principal Investigator Email
JMartinezR@hospitaldelmar.cat
Contact Person Name
Jose Enrique Martinez Rodriguez
Contact Person Email
JMartinezR@hospitaldelmar.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Neurologia
Principal Investigator Name
MARIA LUISA MARTINEZ GINES
Principal Investigator Email
marisamgines@hotmail.com
Contact Person Name
MARIA LUISA MARTINEZ GINES
Contact Person Email
marisamgines@hotmail.com
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Neurology
Principal Investigator Name
Gary Alvarez Bravo
Principal Investigator Email
garyalvarez.girona.ics@gencat.cat
Contact Person Name
Gary Alvarez Bravo
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Neurologia
Principal Investigator Name
Aida ORVIZ GARCÍA
Principal Investigator Email
aida.orviz@gmail.com
Contact Person Name
Aida ORVIZ GARCÍA
Contact Person Email
aida.orviz@gmail.com
Site Name
Hospital Universitario Donostia
Department Name
Departamento de Neurología
Principal Investigator Name
Tamara Castillo Trivino
Principal Investigator Email
tamara.castillotrivino@osakidetza.net
Contact Person Name
Tamara Castillo Trivino
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Departamento de Neurología
Principal Investigator Name
Ines Gonzalez Suarez
Principal Investigator Email
igonsua@gmail.com
Contact Person Name
Ines Gonzalez Suarez
Contact Person Email
igonsua@gmail.com
Site Name
Hospital Universitario De Cruces
Department Name
Departamento de Neurología
Principal Investigator Name
Alfredo Rodriguez-Antiguedad Zarrantz
Principal Investigator Email
alfredo.r.antiguedad.z@gmail.com
Contact Person Name
Alfredo Rodriguez-Antiguedad Zarrantz
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Departamento de Neurología
Principal Investigator Name
Francisco Carlos Perez-Miralles
Principal Investigator Email
miralles_neuro@hotmail.com
Contact Person Name
Francisco Carlos Perez-Miralles
Contact Person Email
miralles_neuro@hotmail.com

Germany

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
27
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Neuro Centrum Science GmbH
Department Name
Neuro Centrum Science GmbH
Principal Investigator Name
Stefan Ries
Principal Investigator Email
stefan.ries@reifschneider.de
Contact Person Name
Stefan Ries
Contact Person Email
stefan.ries@reifschneider.de
Site Name
Medizinische Versorgungszentren St. Josefs-Krankenhaus Potsdam GmbH
Department Name
Neurology
Principal Investigator Name
Christian-Oliver Albert
Principal Investigator Email
c.albert@alexianer.de
Contact Person Name
Christian-Oliver Albert
Contact Person Email
c.albert@alexianer.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Matthias SCHWAB
Principal Investigator Email
matthias.schwab@med.uni-jena.de
Contact Person Name
Matthias SCHWAB
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik für Neurologie
Principal Investigator Name
Maria SEIPELT
Principal Investigator Email
seipelt@med.uni-marburg.de
Contact Person Name
Maria SEIPELT
Contact Person Email
seipelt@med.uni-marburg.de
Site Name
NeuroZentrum Bielefeld
Department Name
Proxis for Neurolgy
Principal Investigator Name
Mathias Boehringer
Principal Investigator Email
Matthias.Boehringer@web.de
Contact Person Name
Mathias Boehringer
Contact Person Email
Matthias.Boehringer@web.de
Site Name
Neurology Institution
Department Name
Neurology
Principal Investigator Name
Marie Brinckmann
Principal Investigator Email
dr.brinckmann@neurologie-berlin.de
Contact Person Name
Marie Brinckmann
Site Name
Studienzentrum Dr. Bischof GmbH
Principal Investigator Name
Felix Bischof
Principal Investigator Email
felix.bischof@me.com
Contact Person Name
Felix Bischof
Contact Person Email
felix.bischof@me.com
Site Name
Universitaetsklinikum Essen AöR
Department Name
Neurologie
Principal Investigator Name
Refik Pul
Principal Investigator Email
refik.pul@uk-essen.de
Contact Person Name
Refik Pul
Contact Person Email
refik.pul@uk-essen.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Department of Neurology
Principal Investigator Name
Steffen Pfeuffer
Principal Investigator Email
steffen.pfeuffer@neuro.med.uni-giessen.de
Contact Person Name
Steffen Pfeuffer
Site Name
Universitaet Muenster
Department Name
Neurologie
Principal Investigator Name
Luisa Klotz
Principal Investigator Email
luisa.klotz@ukmuenster.de
Contact Person Name
Luisa Klotz
Contact Person Email
luisa.klotz@ukmuenster.de

Slovakia

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
38
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
Department Name
Neurologicke oddelenie - Klinika SZU
Principal Investigator Name
Frantisek Jurcaga
Principal Investigator Email
fjurcaga@gmail.com
Contact Person Name
Frantisek Jurcaga
Contact Person Email
fjurcaga@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
6
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
St. Luke's Hospital S.A.
Department Name
Department of Neurology
Principal Investigator Name
ANASTASIOS OROLOGAS
Principal Investigator Email
orologas@med.auth.gr
Contact Person Name
ANASTASIOS OROLOGAS
Contact Person Email
orologas@med.auth.gr
Site Name
General University Hospital Of Larissa
Department Name
Department of Neurology, University General Hospital of Larissa
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 Attikon
Department Name
Neurology Clinic
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
gtsivgou@med.uoa.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
gtsivgou@med.uoa.gr

Austria

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
22
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Johannes Kepler University Linz
Department Name
Med Campus III., Klinik für Neurologie 2
Principal Investigator Name
Gerhard Traxler
Principal Investigator Email
Gerhard.Traxler@kepleruniklinikum.at
Contact Person Name
Gerhard Traxler
Site Name
Praxisgemeinschaft Martinstrasse
Principal Investigator Name
Fritz Leutmezer
Principal Investigator Email
office@neuro-logisch.at
Contact Person Name
Fritz Leutmezer
Contact Person Email
office@neuro-logisch.at

Romania

Earliest CTIS Part Ii Submission Date
24-07-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
96
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Neurologie
Principal Investigator Name
Cristina Tiu
Principal Investigator Email
cristinatiu@yahoo.com
Contact Person Name
Cristina Tiu
Contact Person Email
cristinatiu@yahoo.com
Site Name
Spitalul Clinic Cai Ferate Constanta
Department Name
Neurologie
Principal Investigator Name
Ana-Maria Ionescu
Principal Investigator Email
anaiulius@yahoo.com
Contact Person Name
Ana-Maria Ionescu
Contact Person Email
anaiulius@yahoo.com

Croatia

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
10
Number Of Sites
1
Number Of Participants
10

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

France

Earliest CTIS Part Ii Submission Date
24-07-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
93
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Centre Hospitalier Dr Jean Eric Techer
Department Name
Departement de Neurologie
Principal Investigator Name
Nemanan SAGNO
Principal Investigator Email
n.sagno@ch-calais.fr
Contact Person Name
Nemanan SAGNO
Contact Person Email
n.sagno@ch-calais.fr
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 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 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 De Colmar
Department Name
Departement de Neurologie
Principal Investigator Name
Claude Gaultier
Principal Investigator Email
claude.gaultier@ch-colmar.fr
Contact Person Name
Claude Gaultier
Contact Person Email
claude.gaultier@ch-colmar.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

Poland

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
27
Number Of Sites
8
Number Of Participants
38

Sites

Site Name
Resmedica Sp. z o.o.
Principal Investigator Name
Elzbieta Jasinska
Principal Investigator Email
resmedicakielce@gmail.com
Contact Person Name
Elzbieta Jasinska
Contact Person Email
resmedicakielce@gmail.com
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Katowice
Principal Investigator Name
Aleksandra Porosinska
Principal Investigator Email
aleksandraporosinska@interia.pl
Contact Person Name
Aleksandra Porosinska
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Principal Investigator Name
Monika MAZURKIEWICZ-KANAR
Principal Investigator Email
kanarmo@wp.pl
Contact Person Name
Monika MAZURKIEWICZ-KANAR
Contact Person Email
kanarmo@wp.pl
Site Name
Ma-Lek Clinical Sp. z o.o.
Department Name
Centrum Terapii SM
Principal Investigator Name
Maciej Maciejowski
Principal Investigator Email
m.m@ctsm.pl
Contact Person Name
Maciej Maciejowski
Contact Person Email
m.m@ctsm.pl
Site Name
Unicardia Specjalistyczne Centrum ... (long name)
Principal Investigator Name
Kamila Zur-Wyrozumska
Principal Investigator Email
kamilaanna@op.pl
Contact Person Name
Kamila Zur-Wyrozumska
Contact Person Email
kamilaanna@op.pl
Site Name
Pratia S.A.
Department Name
MTZ Clinical Research Powered By Pratia
Principal Investigator Name
Katarzyna Zajda
Principal Investigator Email
badacz@pratia.com
Contact Person Name
Katarzyna Zajda
Contact Person Email
badacz@pratia.com
Site Name
Centrum Neurologii Krzysztof Selmaj
Principal Investigator Name
Krzysztof Selmaj
Principal Investigator Email
kselmaj@gmail.com
Contact Person Name
Krzysztof Selmaj
Contact Person Email
kselmaj@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Zespol Poradni Specjalistycznych - Botaniczna 3, Poradnia Neurologiczna
Principal Investigator Name
Agnieszka Slowik
Principal Investigator Email
aslowik@su.krakow.pl
Contact Person Name
Agnieszka Slowik
Contact Person Email
aslowik@su.krakow.pl

Lithuania

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
26
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
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

Czechia

Earliest CTIS Part Ii Submission Date
24-07-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
91
Number Of Sites
6
Number Of Participants
83

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Neurologicka klinika 3. LF UK a FNKV
Principal Investigator Name
Ivana Stetkarova
Principal Investigator Email
ivana.stetkarova@fnkv.cz
Contact Person Name
Ivana Stetkarova
Contact Person Email
ivana.stetkarova@fnkv.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Neurologicka klinika
Principal Investigator Name
Jan Kocica
Principal Investigator Email
kocica.jan@fnbrno.cz
Contact Person Name
Jan Kocica
Contact Person Email
kocica.jan@fnbrno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologicka klinika - RS centrum
Principal Investigator Name
Veronika Ticha
Principal Investigator Email
veronika.ticha@vfn.cz
Contact Person Name
Veronika Ticha
Contact Person Email
veronika.ticha@vfn.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Neurologicka klinika
Principal Investigator Name
Pavel Hradilek
Principal Investigator Email
pavel.hradilek@fno.cz
Contact Person Name
Pavel Hradilek
Contact Person Email
pavel.hradilek@fno.cz
Site Name
Krajska zdravotni a.s.
Department Name
MS centrum pri neurologickem oddeleni
Principal Investigator Name
Marta Vachova
Principal Investigator Email
marta.vachova@kzcr.eu
Contact Person Name
Marta Vachova
Contact Person Email
marta.vachova@kzcr.eu
Site Name
Fakultni Nemocnice V Motole
Department Name
Neurologicka klinika 2. LF UK a FN Motol
Principal Investigator Name
Jana Libertinova
Principal Investigator Email
jana.libertinova@fnmotol.cz
Contact Person Name
Jana Libertinova
Contact Person Email
jana.libertinova@fnmotol.cz

Italy

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
29
Number Of Sites
15
Number Of Participants
50

Sites

Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Neurologia
Principal Investigator Name
Marco Capobianco
Principal Investigator Email
capobianco.m@ospedale.cuneo.it
Contact Person Name
Marco Capobianco
Contact Person Email
capobianco.m@ospedale.cuneo.it
Site Name
University Hospital Of Ferrara
Department Name
Neurologia
Principal Investigator Name
Eleonora Baldi
Principal Investigator Email
e.baldi@ospfe.it
Contact Person Name
Eleonora Baldi
Contact Person Email
e.baldi@ospfe.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Neurologia
Principal Investigator Name
Domizia Vecchio
Principal Investigator Email
domizia.vecchio@uniupo.it
Contact Person Name
Domizia Vecchio
Contact Person Email
domizia.vecchio@uniupo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Dipartimento di neurologia
Principal Investigator Name
Maria Matilde Inglese
Principal Investigator Email
m.inglese@unige.it
Contact Person Name
Maria Matilde Inglese
Contact Person Email
m.inglese@unige.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Neurologia
Principal Investigator Name
Alessia Di Sapio
Principal Investigator Email
alessiadisapio@fastwebnet.it
Contact Person Name
Alessia Di Sapio
Contact Person Email
alessiadisapio@fastwebnet.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Neurologia
Principal Investigator Name
Francesco Patti
Principal Investigator Email
patti@unict.it
Contact Person Name
Francesco Patti
Contact Person Email
patti@unict.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 Parma
Department Name
Neurologia
Principal Investigator Name
Elena Tsantes
Principal Investigator Email
etsantes@ao.pr.it
Contact Person Name
Elena Tsantes
Contact Person Email
etsantes@ao.pr.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Neurologia
Principal Investigator Name
Antonella Conte
Principal Investigator Email
antonella.conte@uniroma1.it
Contact Person Name
Antonella Conte
Contact Person Email
antonella.conte@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Neurologia
Principal Investigator Name
Diana Ferraro
Principal Investigator Email
diana.ferraro@unimore.it
Contact Person Name
Diana Ferraro
Contact Person Email
diana.ferraro@unimore.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Neurologia
Principal Investigator Name
Maria Grazia Piscaglia
Principal Investigator Email
mariagrazia.piscaglia@auslromagna.it
Contact Person Name
Maria Grazia Piscaglia
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Neurologia
Principal Investigator Name
Mariarosaria Valente
Principal Investigator Email
mariarosaria.valente@uniud.it
Contact Person Name
Mariarosaria Valente
Contact Person Email
mariarosaria.valente@uniud.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
Istituto Neurologico Casimiro Mondino
Principal Investigator Name
Elena Colombo
Principal Investigator Email
elena.colombo@mondino.it
Contact Person Name
Elena Colombo
Contact Person Email
elena.colombo@mondino.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Neurologia
Principal Investigator Name
Elisabetta Signoriello
Principal Investigator Email
elisabetta.signoriello@unicampania.it
Contact Person Name
Elisabetta Signoriello

Portugal

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
38
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Serviço Neurologia
Principal Investigator Name
Ines Marques
Principal Investigator Email
maria.ibmarques@hospitaldaluz.pt
Contact Person Name
Ines Marques
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Serviço Neurologia
Principal Investigator Name
Carla Cecília Nunes
Principal Investigator Email
6127@chuc.min-saude.pt
Contact Person Name
Carla Cecília Nunes
Contact Person Email
6127@chuc.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Serviço Neurologia
Principal Investigator Name
Joao Sequeira
Principal Investigator Email
joao.sequeira@chlc.min-saude.pt
Contact Person Name
Joao Sequeira

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 (code: 15)
Name
Labcorp Central Laboratory Services LP
Responsibilities
code: 4
Name
Bioclinica S.A.
Responsibilities
code: 4
Name
Azenta US Inc.
Responsibilities
code: 4
Name
Azenta Germany GmbH
Responsibilities
code: 4
Name
Endpoint Clinical Inc.
Responsibilities
code: 3

Third parties

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

Investigational products

Investigational Product Name
Frexalimab
Active Substance
FREXALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenious infusion
Route
Intravenious infusion
Authorisation Status
Not authorised (prodAuthStatus: 1)
Maximum Dose
1800 mg (maxDailyDoseAmount)
Investigational Product Name
AUBAGIO 14 mg film-coated tablets
Active Substance
TERIFLUNOMIDE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketingAuthNumber: EU/1/13/838/... prodAuthStatus: 2)
Starting Dose
14 mg once daily
Dose Levels
14 mg (oral daily)
Frequency
Once daily
Maximum Dose
14 mg daily
Investigational Product Name
Matched placebo for test product frexalimab
Modality
Other
Investigational Product Name
Matched placebo for comparator teriflunomide
Modality
Other
Investigational Product Name
COLESTYRAMINE
Active Substance
COLESTYRAMINE
Modality
Other
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (scientificProductEvCode: SCP15611709 prodAuthStatus: 2)

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