Clinical trial • Phase III • Neurology

REMIBRUTINIB for Relapsing multiple sclerosis

Phase III trial of REMIBRUTINIB for Relapsing multiple sclerosis.

Overview

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

Key dates

Initial CTIS Submission Date
14-04-2025
First CTIS Authorization Date
01-08-2025

Trial design

Randomised, open-label, ocrelizumab — comparator; treated according to routine clinical practice and at standard doses (commercially confidential information).-controlled Phase III trial in Belgium, Denmark, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Ocrelizumab — comparator; treated according to routine clinical practice and at standard doses (Commercially confidential information).
Target Sample Size
185
Trial Duration For Participant
730

Eligibility

Recruits 185 adults.

Pregnancy Exclusion
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception and do not donate eggs while taking study treatment and for (Commercially confidential information) after stopping ocrelizumab.

Inclusion criteria

  • {"criterion_text":"-Signed informed consent obtained prior to any assessment performed (confirm at Screening Visit).\n-Male or female aged 40 (Commercially confidential information) at Screening.\n-Diagnosis of RMS according to the revised 2017 McDonald criteria at Screening.\n-EDSS score of (Commercially confidential information) at Screening and randomization.\n-Treated with ocrelizumab according to routine clinical practice and at standard doses (Commercially confidential information).\n-Neurologically stable within 30 days prior to Screening and randomization (including no MS relapse in this period).\n-Suitable to be switched to remibrutinib based on physician judgement or patient preference."}

Exclusion criteria

  • {"criterion_text":"-Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria at Screening.\n-Participants who have had a splenectomy.\n-Active clinically significant systemic bacterial, viral, parasitic or fungal infections in the judgement of the investigator prior to randomization (e.g. infections requiring hospitalization or i.v. antibiotics)\n-Active, chronic disease of the immune system (including stable disease treated with immune therapy, e.g. leflunomide, methotrexate) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.\n-Participants with a known immunodeficiency syndrome (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, or drug induced immune deficiency other than those caused by anti-CD20 therapy), or tested positive for human immunodeficiency virus (HIV) antibody, at Screening.\n-Participants at risk of developing or having reactivation of hepatitis: Positive results at Screening for serological markers for hepatitis (H) A, B, C, and E indicating acute or chronic infection: - anti-HA Immunoglobulin (Ig) M (IgM) - HB surface Antigen (HBs Ag) and/or anti-HBc IgM and/or HB virus deoxyribonucleic acid (DNA) - anti-HBc positive - anti-HC IgG (if positive IgG, HC Virus (HCV)-RNA Polymerase Chain Reaction (PCR) will be performed and if negative, participant can be randomized) - anti-HE IgM positive (regardless of IgG status)\n-Participants with any of the following abnormal hematology laboratory values at Screening: - Hemoglobin: (Commercially confidential information) - Platelets: (Commercially confidential information) - Absolute lymphocyte count (Commercially confidential information) - White blood cells: (Commercially confidential information) - Neutrophils: (Commercially confidential information) - (Commercially confidential information)\n-Resting QT interval corrected by Fridericia’s formula (QTcF) ≥ (Commercially confidential information) msec (male) or ≥ (Commercially confidential information) msec (female) at pre-treatment as per central ECG reading at Screening visit.\n-Use of exclusionary medication prior to Screening/randomization (as defined in the protocol).\n-Use of other investigational drugs within 5 half-lives of Screening; or within 30 days (e.g. small molecules); or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics); whichever is longer; or longer if required by local regulations.\n-Significant (Commercially confidential information) at Screening.\n-Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception and do not donate eggs while taking study treatment and for (Commercially confidential information) after stopping ocrelizumab.\n-History of life-threatening infusion or injection reaction related to ocrelizumab, such as acute hypersensitivity or acute respiratory distress syndrome.\n-History of clinically significant CNS disease (e.g., stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at Screening.\n-Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML prior to randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Annualized rate of new or enlarging T2 lesions (AR-NELT2) on MRI at Month 24 (relative to baseline MRI scan).","definition_or_measurement_approach":"AR-NELT2 measured on MRI at Month 24 relative to baseline MRI scan (annualized rate of new or enlarging T2 lesions)."}

Secondary endpoints

  • {"endpoint_text":"-Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI between baseline and Month 24.","definition_or_measurement_approach":"NEDA-3 defined as absence of confirmed MS relapses, absence of 6-month confirmed disability progression (6mCDP), and absence of new/enlarging T2 lesions on MRI between baseline and Month 24."}
  • {"endpoint_text":"-Adverse events, laboratory data, vital signs, electrocardiograms (ECGs), (Commercially confidential information).","definition_or_measurement_approach":"Safety assessments including adverse events, laboratory tests, vital signs and ECG monitoring as recorded during the study (additional details marked commercially confidential)."}
  • {"endpoint_text":"-Extension Part: Adverse events, laboratory data, vital signs, electrocardiogram (ECG), (Commercially confidential information).","definition_or_measurement_approach":"Extension part safety assessments including adverse events, laboratory data, vital signs and ECG (details commercially confidential)."}
  • {"endpoint_text":"-Extension Part: - Annualized rate of new or enlarging T2 lesions on MRI - Participants with NEDA-3.","definition_or_measurement_approach":"Extension part efficacy endpoints: annualized rate of new or enlarging T2 lesions on MRI and proportion of participants meeting NEDA-3 in the extension period."}

Recruitment

Planned Sample Size
185
Recruitment Window Months
68
Consent Approach
Signed informed consent obtained prior to any assessment performed (confirm at Screening Visit). Adult informed consent forms available (multiple country-specific ICFs present in the submission). Separate data protection consent forms are provided. Country-specific ICFs and related documents (e.g. follow-up for pregnant participant) are listed for participating countries.

Geography

Total Number Of Sites
62
Total Number Of Participants
215

Belgium

Earliest CTIS Part Ii Submission Date
10-07-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
140
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
#2001: Neurology
Principal Investigator Name
Melissa Cambron
Principal Investigator Email
melissa.cambron@azsintjan.be
Contact Person Name
Melissa Cambron
Contact Person Email
melissa.cambron@azsintjan.be
Site Name
Noorderhart
Department Name
#2002: ​Neurology
Principal Investigator Name
Cornelia Rogojan
Principal Investigator Email
Cornelia.rogojan@noorderhart.be
Contact Person Name
Cornelia Rogojan

Denmark

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
130
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Rigshospitalet
Department Name
#2012: Afdeling for Hjerne- og Nervesygdomme
Principal Investigator Name
Finn Sellebjerg
Principal Investigator Email
finn.sellebjerg@regionh.dk
Contact Person Name
Finn Sellebjerg
Contact Person Email
finn.sellebjerg@regionh.dk
Site Name
Region Midtjylland
Department Name
#2011: Neurologisk Forskning
Principal Investigator Name
Kristina Bacher Svendsen
Principal Investigator Email
krissven@rm.dk
Contact Person Name
Kristina Bacher Svendsen
Contact Person Email
krissven@rm.dk

France

Earliest CTIS Part Ii Submission Date
20-06-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
154
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
#2107: Neurology
Principal Investigator Name
Jérôme DE SEZE
Principal Investigator Email
Jerome.deseze@chru-strasbourg.fr
Contact Person Name
Jérôme DE SEZE
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
#2105: Neurology
Principal Investigator Name
Amélie DOS SANTOS
Principal Investigator Email
Amelie.dos-santos@chu-poitiers.fr
Contact Person Name
Amélie DOS SANTOS
Site Name
Centre Hospitalier Regional De Marseille
Department Name
#2109: Neurology
Principal Investigator Name
Audrey RICO
Principal Investigator Email
Audrey.rico@ap-hm.fr
Contact Person Name
Audrey RICO
Contact Person Email
Audrey.rico@ap-hm.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
#2110: Neurology
Principal Investigator Name
Julien POUPART
Principal Investigator Email
Poupart.julien@ghicl.fr
Contact Person Name
Julien POUPART
Contact Person Email
Poupart.julien@ghicl.fr
Site Name
Centre Hospitalier Intercommunal De Poissy Saint Germain
Department Name
#2113: Neurology
Principal Investigator Name
Olivier HEINZLEF
Principal Investigator Email
Olivier.heinzlef@ght-yvelinesnord.fr
Contact Person Name
Olivier HEINZLEF
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
#2114: Neurology
Principal Investigator Name
Mikael COHEN
Principal Investigator Email
Cohen.m@chu-nices.fr
Contact Person Name
Mikael COHEN
Contact Person Email
Cohen.m@chu-nices.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
#2112: Neurology
Principal Investigator Name
Eric THOUVENOT
Principal Investigator Email
Eric.thouvenot@chu-nimes.fr
Contact Person Name
Eric THOUVENOT
Contact Person Email
Eric.thouvenot@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#2111: Neurology
Principal Investigator Name
Jonathan CIRON
Principal Investigator Email
Ciron.j@chu-toulouse.fr
Contact Person Name
Jonathan CIRON
Contact Person Email
Ciron.j@chu-toulouse.fr
Site Name
CHU Gabriel-Montpied
Department Name
#2102: Neurology
Principal Investigator Name
Pierre CLAVELOU
Principal Investigator Email
Pclavelou@chu-clermontferrand.fr
Contact Person Name
Pierre CLAVELOU
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
#2108: Neurology
Principal Investigator Name
Inès DOGHRI
Principal Investigator Email
i.doghri@chu-tours.fr
Contact Person Name
Inès DOGHRI
Contact Person Email
i.doghri@chu-tours.fr
Site Name
CHU Besancon
Department Name
#2104: Neurology
Principal Investigator Name
Eric BERGER
Principal Investigator Email
Eberger@chu-besancon.fr
Contact Person Name
Eric BERGER
Contact Person Email
Eberger@chu-besancon.fr
Site Name
Fondation A De Rothschild
Department Name
#2103: Neurology
Principal Investigator Name
Januel EDOUARD
Principal Investigator Email
Edjanuel@for.paris
Contact Person Name
Januel EDOUARD
Contact Person Email
Edjanuel@for.paris
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
#2101: Neurology
Principal Investigator Name
Aurélie RUET
Principal Investigator Email
Aurelie.ruet@chu-bordeaux.fr
Contact Person Name
Aurélie RUET
Contact Person Email
Aurelie.ruet@chu-bordeaux.fr

Greece

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
185
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
General University Hospital Of Larissa
Department Name
#2302: Department of Neurology
Principal Investigator Name
Efthimios Dardiotis
Principal Investigator Email
ebsdar@gmail.com
Contact Person Name
Efthimios Dardiotis
Contact Person Email
ebsdar@gmail.com
Site Name
University General Hospital Attikon
Department Name
#2303: 2nd Department of Neurology
Principal Investigator Name
Sotirios Giannopoulos
Principal Investigator Email
sgiannop@uoi.gr
Contact Person Name
Sotirios Giannopoulos
Contact Person Email
sgiannop@uoi.gr
Site Name
St. Luke's Hospital S.A.
Department Name
#2301: Multiple Sclerosis Center (Department of Neurology)
Principal Investigator Name
Konstantinos Notas
Principal Investigator Email
konstantinos_notas@hotmail.com
Contact Person Name
Konstantinos Notas
Contact Person Email
konstantinos_notas@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
148
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
#2332: U.O. Clinica Neurologica
Principal Investigator Name
Matilde INGLESE
Principal Investigator Email
m.inglese@unige.it
Contact Person Name
Matilde INGLESE
Contact Person Email
m.inglese@unige.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
#2334: Centro Sclerosi Multipla e Neuromielite Ottica S.C. Neurologia Universitaria
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
Ospedale San Raffaele S.r.l.
Department Name
#2331: Divisione di neuroscienze - Dip. Neurologia - Pad. DIMER
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
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
#2335: Centro Sclerosi Multipla U.S.S. Neuroimmunologia
Principal Investigator Name
Sara LA GIOIA
Principal Investigator Email
slagioia@asst-pg23.it
Contact Person Name
Sara LA GIOIA
Contact Person Email
slagioia@asst-pg23.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
#2333: U.O.S.D. Centro di Riferimento Regionale per la Sclerosi Multipla
Principal Investigator Name
Girolama Alessandra MARFIA
Principal Investigator Email
marfia@uniroma2.it
Contact Person Name
Girolama Alessandra MARFIA
Contact Person Email
marfia@uniroma2.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
#2340: U.O.S. Sclerosi Multipla U.O.C. Neurologia
Principal Investigator Name
Massimiliano MIRABELLA
Principal Investigator Email
massimiliano.mirabella@unicatt.it
Contact Person Name
Massimiliano MIRABELLA
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
#2336: U.O.S.S. Sclerosi Multipla U.O.S.C. Neuroncologia e Neuroinfiammazione
Principal Investigator Name
Elena COLOMBO
Principal Investigator Email
elena.colombo@mondino.it
Contact Person Name
Elena COLOMBO
Contact Person Email
elena.colombo@mondino.it

Slovakia

Earliest CTIS Part Ii Submission Date
13-06-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
171
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University Hospital Bratislava
Department Name
#2381 Neurologická klinika SZU a UNB
Principal Investigator Name
Viera Hančinová
Principal Investigator Email
dr.hancinova@gmail.com
Contact Person Name
Viera Hančinová
Contact Person Email
dr.hancinova@gmail.com
Site Name
Fakultna Nemocnica Trnava
Department Name
#2382: Neurologická klinika FN Trnava a SZU
Principal Investigator Name
Georgi Krastev
Principal Investigator Email
georgi.krastev@fntt.sk
Contact Person Name
Georgi Krastev
Contact Person Email
georgi.krastev@fntt.sk

Spain

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
225
Number Of Sites
13
Number Of Participants
52

Sites

Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
#2408: Neurología
Principal Investigator Name
Lamberto Landete Pascual
Principal Investigator Email
landete_lam@gva.es
Contact Person Name
Lamberto Landete Pascual
Contact Person Email
landete_lam@gva.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
#2412: Neurología
Principal Investigator Name
María Luisa Martinez Gines
Principal Investigator Email
marisamgines@hotmail.com
Contact Person Name
María Luisa Martinez Gines
Contact Person Email
marisamgines@hotmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
#2403: 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 Universitari Vall D Hebron
Department Name
#2404: Neurología
Principal Investigator Name
Xavier Montalban Gairin
Principal Investigator Email
xavier.montalban@cem-cat.org
Contact Person Name
Xavier Montalban Gairin
Contact Person Email
xavier.montalban@cem-cat.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
#2411: Neurología
Principal Investigator Name
Lucienne Costa-Frossard França
Principal Investigator Email
lucienne.costa@salud.madrid.org
Contact Person Name
Lucienne Costa-Frossard França
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
#2409: Neurología
Principal Investigator Name
Rosario Blasco Quilez
Principal Investigator Email
neimtrials.hpth@salud.madrid.org
Contact Person Name
Rosario Blasco Quilez
Site Name
Hospital Universitario Reina Sofia
Department Name
#2407: Neurología
Principal Investigator Name
Eduardo Agüera Morales
Principal Investigator Email
doctoredu@gmail.com
Contact Person Name
Eduardo Agüera Morales
Contact Person Email
doctoredu@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
#2405: 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
Hospital Universitario Fundacion Jimenez Diaz
Department Name
#2410: Neurología
Principal Investigator Name
Irene del Pilar Moreno Torres
Principal Investigator Email
irene.morenot@quironsalud.es
Contact Person Name
Irene del Pilar Moreno Torres
Contact Person Email
irene.morenot@quironsalud.es
Site Name
Hospital Clinico San Carlos
Department Name
#2401: Neurología
Principal Investigator Name
Celia Oreja-Guevara
Principal Investigator Email
orejacbn@gmail.com
Contact Person Name
Celia Oreja-Guevara
Contact Person Email
orejacbn@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
#2406: Neurología
Principal Investigator Name
Ana María Alonso Torres
Principal Investigator Email
anam.alonso.ssp@juntadeandalucia.es
Contact Person Name
Ana María Alonso Torres
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
#2402: Neurología
Principal Investigator Name
Francisco Perez Miralles
Principal Investigator Email
perez_fca@gva.es
Contact Person Name
Francisco Perez Miralles
Contact Person Email
perez_fca@gva.es
Site Name
Hospital Santa Caterina Ias
Department Name
#2413: Neurología
Principal Investigator Name
Gary Ciceron Álvarez Bravo
Principal Investigator Email
galvarez@idibgi.org
Contact Person Name
Gary Ciceron Álvarez Bravo
Contact Person Email
galvarez@idibgi.org

Portugal

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
263
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
#2464: Serviço de Neurologia
Principal Investigator Name
Inês Correia
Principal Investigator Email
uid@ulscoimbra.min-saude.pt
Contact Person Name
Inês Correia
Contact Person Email
uid@ulscoimbra.min-saude.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
#2462: Serviço de Neurologia
Principal Investigator Name
João Cerqueira
Principal Investigator Email
joao.cerqueira@ccabraga.org
Contact Person Name
João Cerqueira
Contact Person Email
joao.cerqueira@ccabraga.org
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
#2463: Serviço de Neurologia
Principal Investigator Name
João Sequeira
Principal Investigator Email
joao.sequeira@ulssjose.min-saude.pt
Contact Person Name
João Sequeira

Czechia

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
24
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
#2052: Neurologicka klinika, MS Centrum
Principal Investigator Name
Miroslav Mares
Principal Investigator Email
miroslav.mares@nempk.cz
Contact Person Name
Miroslav Mares
Contact Person Email
miroslav.mares@nempk.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
#2054: Neurologie MS centrum
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
Fakultni Nemocnice Hradec Kralove
Department Name
#2051: Neurologicka klinika, MS centrum
Principal Investigator Name
Zbysek Pavelek
Principal Investigator Email
zbysekpavelek@email.cz
Contact Person Name
Zbysek Pavelek
Contact Person Email
zbysekpavelek@email.cz
Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
#2056: Centrum pro diagnostiku a léčbu demyelinizačních onemocnění
Principal Investigator Name
Jana Libertinova
Principal Investigator Email
jana.libertinova@fnmotol.cz
Contact Person Name
Jana Libertinova
Contact Person Email
jana.libertinova@fnmotol.cz
Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
#2053: Neurologicke oddeleni
Principal Investigator Name
Ondrej Skoda
Principal Investigator Email
skodao@nemji.cz
Contact Person Name
Ondrej Skoda
Contact Person Email
skodao@nemji.cz
Site Name
Fakultni Nemocnice Brno
Department Name
#2055: Neurologick klinika
Principal Investigator Name
Pavel Stourac
Principal Investigator Email
stourac.pavel@fnbrno.cz
Contact Person Name
Pavel Stourac
Contact Person Email
stourac.pavel@fnbrno.cz

Germany

Earliest CTIS Part Ii Submission Date
18-03-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
26
Number Of Sites
11
Number Of Participants
27

Sites

Site Name
Neuro Centrum Science GmbH
Department Name
#2207: Neurologie
Principal Investigator Name
Stefan Ries
Principal Investigator Email
s.ries@neuro-centrum-science.de
Contact Person Name
Stefan Ries
Site Name
Universitaet Muenster
Department Name
#2204: Klinik fuer 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
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#2211: Klinik und Hochschulambulanz fuer Neurologie
Principal Investigator Name
Carolin Otto
Principal Investigator Email
carolin.otto@charite.de
Contact Person Name
Carolin Otto
Contact Person Email
carolin.otto@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
#2209: Klinik für Neurologie
Principal Investigator Name
Makbule Senel
Principal Investigator Email
makbule.senel@uni-ulm.de
Contact Person Name
Makbule Senel
Contact Person Email
makbule.senel@uni-ulm.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
#2212: Neurologische Klinik
Principal Investigator Name
Klemens Ruprecht
Principal Investigator Email
klemens.ruprecht@med.uni-heidelberg.de
Contact Person Name
Klemens Ruprecht
Site Name
Philipps-Universitaet Marburg
Department Name
#2213: Clinic for neurology
Principal Investigator Name
Clemens Warnke
Principal Investigator Email
clemens.warnke@uni-marburg.de
Contact Person Name
Clemens Warnke
Contact Person Email
clemens.warnke@uni-marburg.de
Site Name
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
Department Name
#2206: ​NeuroPoint​
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
Universitaetsklinikum Essen AöR
Department Name
#2205: Klinik für 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
Katholisches Klinikum Bochum gGmbH
Department Name
#2215: Klinik fuer Neurologie
Principal Investigator Name
Simon Faissner
Principal Investigator Email
Simon.faissner@ruhr-uni-bochum.de
Contact Person Name
Simon Faissner
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
#2203: Klinik und Poliklinik für Neurologie
Principal Investigator Name
Matthias Grothe
Principal Investigator Email
matthias.grothe@med.uni-greifswald.de
Contact Person Name
Matthias Grothe
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
#2201: Neurology
Principal Investigator Name
Klemens Angstwurm
Principal Investigator Email
Klemens.Angstwurm@medbo.de
Contact Person Name
Klemens Angstwurm
Contact Person Email
Klemens.Angstwurm@medbo.de

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
Central trial services; ECG Machine provision, Central ECG Collection, Analysis, Reporting; other duties (codes: 1,15,3)
Name
Syneos Health Inc.
Responsibilities
Duties code 1
Name
Parexel International (IRL) Limited
Responsibilities
Duties code 12
Name
Icon Clinical Research Limited
Responsibilities
Duties code 1

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Travel and Reimbursement for site visits.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1; ECG Machine provision, Central ECG Collection, Analysis, Reporting; 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"15; 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"13; EDSS Licensing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"12","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"13; Central MRI Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Ancillary Supplies","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LOU064
Active Substance
REMIBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Investigational (prodAuthStatus:1)
Investigational Product Name
OCRELIZUMAB
Active Substance
OCRELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS|INTRAVENOUS
Route
SUBCUTANEOUS/INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus:2)

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