Clinical trial • Phase II • Neurology

RO7268489 for Progressive multiple sclerosis | Multiple sclerosis

Phase II trial of RO7268489 for Progressive multiple sclerosis | Multiple sclerosis.

Overview

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

Key dates

Initial CTIS Submission Date
24-09-2025
First CTIS Authorization Date
28-01-2026

Trial design

Randomised, placebo (ro7268489 placebo) as comparator (add-on to background ocrelizumab). background therapy: ocrevus (ocrelizumab 300 mg concentrate for solution for infusion) provided as part of participant treatment.-controlled Phase II trial in France, Poland, Italy and others.

Randomised
Yes
Comparator
Placebo (RO7268489 Placebo) as comparator (add-on to background ocrelizumab). Background therapy: Ocrevus (ocrelizumab 300 mg concentrate for solution for infusion) provided as part of participant treatment.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
140

Eligibility

Recruits 140 Vulnerable population selected. Listed subject information and informed consent documents include 'L1_SIS and ICF Infant', 'BP46016_Autorizacion informacion recien nacido' and multiple infant/IAF ICF documents, indicating availability of age-specific ICF materials for infants..

Vulnerable Population
Vulnerable population selected. Listed subject information and informed consent documents include 'L1_SIS and ICF Infant', 'BP46016_Autorizacion informacion recien nacido' and multiple infant/IAF ICF documents, indicating availability of age-specific ICF materials for infants.

Inclusion criteria

  • {"criterion_text":"- Age 18 to 60 years, inclusive, at the time of signing the Informed Consent Form"}
  • {"criterion_text":"- Progressive multiple sclerosis, in accordance with the revised 2017 McDonald criteria (Thompson 2018)"}
  • {"criterion_text":"- Expanded Disability Status Scale (EDSS) at Screening between 3.0 and 6.0 inclusive"}
  • {"criterion_text":"- Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit, according to criteria provided in the protocol"}
  • {"criterion_text":"- For patients who received ocrelizumab in the past and stopped it more than 2 years prior to screening, the reason for stopping or interrupting ocrelizumab must have been unrelated to safety / lack of efficacy and such patients must have normal B cell count at screening"}
  • {"criterion_text":"- Agreement to wear digital gait assessment device as per study protocol"}

Exclusion criteria

  • {"criterion_text":"- MS relapse during the 6 months preceding the randomization date"}
  • {"criterion_text":"- Lack of peripheral venous access"}
  • {"criterion_text":"- History of alcohol or other drug abuse, in the opinion of the investigator, within 5 years prior to screening"}
  • {"criterion_text":"- Inability to complete an magnetic resonance imaging (MRI)"}
  • {"criterion_text":"- Contraindications to ocrelizumab mandatory pre-medications"}
  • {"criterion_text":"- Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time from randomization to the first occurrence of composite confirmed disability progression confirmed for at least 12 weeks (cCDP12) according to at least one of the following three criteria: o 12-week confirmed disability progression (CDP12) o 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or o 12-week confirmed increase in 9-Hole Peg Test (9-HPT)","definition_or_measurement_approach":"Time from randomization to first occurrence of composite confirmed disability progression sustained for at least 12 weeks (cCDP12). cCDP12 is defined by at least one of: 12-week confirmed disability progression (CDP12), 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT), or 12-week confirmed increase in 9-Hole Peg Test (9-HPT)."}

Secondary endpoints

  • {"endpoint_text":"- Time from randomization to the first occurrence of 24-week confirmed ≥ 4-point decrease (worsening) in Symbol Digit Modalities Test (SDMT)","definition_or_measurement_approach":"Time from randomization to first occurrence of a confirmed ≥4-point decrease in SDMT at 24 weeks compared with baseline."}
  • {"endpoint_text":"- Plasma 2-arachidonoylglycreol (2-AG) levels","definition_or_measurement_approach":"Measurement of plasma 2-AG concentrations."}
  • {"endpoint_text":"- Change from baseline in plasma 2-AG levels","definition_or_measurement_approach":"Change from baseline in plasma 2-AG concentrations assessed at defined study timepoints."}
  • {"endpoint_text":"- Incidence, severity, and causal relationship of adverse events (AEs)","definition_or_measurement_approach":"Recording and assessment of AEs including incidence, severity grading and investigator-determined causal relationship."}
  • {"endpoint_text":"- Incidence of treatment discontinuations due to AEs","definition_or_measurement_approach":"Number and proportion of participants discontinuing treatment for adverse events."}
  • {"endpoint_text":"- Changes in vital signs and ECG parameters","definition_or_measurement_approach":"Assessment of vital signs and ECG recordings versus baseline."}
  • {"endpoint_text":"- Incidence of abnormal laboratory findings","definition_or_measurement_approach":"Incidence and description of clinically significant laboratory abnormalities."}
  • {"endpoint_text":"- Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Proportion of participants with suicidal ideation or behavior determined by C-SSRS assessments."}
  • {"endpoint_text":"- Plasma concentrations of RO7268489 and its metabolite(s) as appropriate","definition_or_measurement_approach":"Plasma PK sampling to quantify RO7268489 and metabolites at specified timepoints."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
140
Recruitment Window Months
51
Consent Approach
Informed consent materials are provided; multiple 'L1_SIS and ICF' documents are listed (Main, Infant, MRI, Lumbar puncture, RBR, IAF) and language-specific ICFs and protocol synopses are included (files in English, Spanish, French, Hungarian, Italian, Polish, Portuguese among others), indicating availability of age-specific consent/information documents. Consent is obtained using the listed subject information and informed consent form documents.

Methods

  • K1/K2 recruitment materials (multiple entries) including Patient posters (site posters) — listed as 'K2_Recruitment Material Poster', 'K2_Recruitment material_Patient_Poster_v1/v2', 'K1_Recruitment Arrangements' and equivalents
  • Patient Caregiver Brochures — listed as 'K2_Patient Caregiver Brochure_redacted' and variants
  • Doctor-to-Patient letters — listed as 'K2_Recruitment material_Doctor To Patient Letter_REDACTED'
  • Informed Consent Flipcharts and patient-facing consent materials — listed as 'K2_Informed Consent Flipchart_redacted', 'L1_SIS and ICF Main', 'L1_SIS and ICF Infant' etc.
  • Social media advertisement — listed as 'K2_Recruitment material_social media ad'
  • Other site-facing materials such as participant ID cards, thank you cards, study guides (multiple 'K1' and 'L2' documents listed)

Geography

Total Number Of Sites
90
Total Number Of Participants
235

France

Earliest CTIS Part Ii Submission Date
05-01-2026
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
25
Number Of Sites
11
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Neurologie
Contact Person Name
Xavier Ayrignac
Contact Person Email
x-ayrignac@chu-montpellier.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neurologie
Contact Person Name
Jerôme De Seze
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurologie
Contact Person Name
Sean Freeman
Contact Person Email
freeman.s@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurologie
Contact Person Name
Aurelie Ruet
Contact Person Email
aurelie.ruet@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Neurologie
Contact Person Name
Eric Thouvenot
Contact Person Email
eric.thouvenot@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Neurologie
Contact Person Name
Sandrine Wiertlewski
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie
Contact Person Name
Celine Louapre
Contact Person Email
celine.louapre@aphp.fr
Site Name
CHRU De Nancy
Department Name
Neurologie
Contact Person Name
Chloe Prunis
Contact Person Email
C.PRUNIS@chru-nancy.fr
Site Name
CHU Gabriel-Montpied
Department Name
Neurologie
Contact Person Name
Pierre Clavelou
Site Name
Hospices Civils De Lyon
Department Name
Neurologie
Contact Person Name
Sandra Vukusic
Contact Person Email
sandra.vukusic@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Neurologie
Contact Person Name
Laure Michel
Contact Person Email
Laure.michel@chu-rennes.fr

Poland

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
42
Number Of Sites
18
Number Of Participants
45

Sites

Site Name
Resmedica Sp. z o.o.
Contact Person Name
Elżbieta Jasinska
Contact Person Email
resmedicakielce@gmail.com
Site Name
Somed Cr Sp. z o.o. sp.k.
Contact Person Name
Marta Milewska - Jędrzejczak
Contact Person Email
jakub.kierzkowski@somed.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Neurologiczny
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
neurozab@sum.edu.pl
Site Name
Pratia S.A.
Contact Person Name
Aleksandra Porosińska
Contact Person Email
sylwia.wieczorek@pratia.com
Site Name
ProNeuro Centrum Medyczne
Contact Person Name
Ewa Krzystanek
Contact Person Email
biuro@proneuro.pl
Site Name
Ma-Lek Clinical Sp. z o.o.
Contact Person Name
Katarzyna Maciejowska
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Contact Person Name
Anna Jamroz-Wisniewska
Site Name
Nmedis Sp. z o.o.
Contact Person Name
Iwona Rościszewska-Żukowska
Contact Person Email
biuro@nmedis.pl
Site Name
EMC Instytut Medyczny S.A. Przychodnia EuroMediCare, Wrocław Łowiecka
Contact Person Name
Monika Susz-Kołodyńska
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Oddział Neurologiczny
Contact Person Name
Waldemar Fryze
Site Name
Zanamed Medical Clinic Sp. z o.o.
Contact Person Name
Małgorzata Kulka
Contact Person Email
info@zanamed.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Contact Person Name
Halina Bartosik-Psujek
Site Name
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Contact Person Name
Jan Ilkowski
Contact Person Email
jan.ilkowski@neurokard.pl
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Contact Person Name
Paweł Bochniak
Contact Person Email
rejestracja@ncbydgoszcz.pl
Site Name
Centrum Medyczne Neuroprotect
Contact Person Name
Anna Karlińska
Contact Person Email
recepcja@neuroprotect.pl
Site Name
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Neurologii
Contact Person Name
Stanisław Rusek
Contact Person Email
sekretariat@rydygierakrakow.pl
Site Name
Neuro-Care Sp. z o.o. sp.k.
Contact Person Name
Gabriela Kłodowska
Contact Person Email
neuro-care@neuro-care.pl

Italy

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
120
Number Of Sites
10
Number Of Participants
30

Sites

Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Neuroscience, Reproductivity Science and Odontostomatology
Contact Person Name
Vincenzo Brescia Morra
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Neuroscienze-Clinica Neurologica UOSD Sclerosi Multipla
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOSD II clinica neurologica
Contact Person Name
Elisabetta Signoriello
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Department of Neurosciences, Neurology and Stroke Unit
Contact Person Name
Stefano Gelibter
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
Multiple Sclerosis Unit
Contact Person Name
Elena Colombo
Contact Person Email
centro.sm@mondino.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
I Division of Neurology and Neurophysiopathology
Contact Person Name
Antonio Gallo
Contact Person Email
antonio.gallo@unicampania.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Sciences
Contact Person Name
Maria Matilde Inglese
Contact Person Email
m.inglese@unige.it
Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Department of Neurosciences, Imaging and Clinical Sciences, School of Medicine
Contact Person Name
Valentina Tomassini
Contact Person Email
valentina.tomassini@unich.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
Neurology Unit
Contact Person Name
Maria Di Gregorio
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Neuroimmunologia Malattie Neuromuscolari
Contact Person Name
Laura Brambilla

Hungary

Earliest CTIS Part Ii Submission Date
07-01-2026
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
23
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
S-Medicon Kft.
Department Name
Neurológia
Contact Person Name
Mária Sátori
Contact Person Email
satori.maria@gmail.com
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Neurológiai Osztály
Contact Person Name
István Deme
Contact Person Email
deme@kmmk.hu
Site Name
Clinexpert Kft.
Department Name
Clinexpert Óbuda Egészségcentruma
Contact Person Name
Ferenc Fazekas
Contact Person Email
drfazekas.clinexpert@gmail.com
Site Name
University Of Pecs
Department Name
Neurológiai Klinika
Contact Person Name
Péter Ács
Contact Person Email
acs.peter@pte.hu
Site Name
University Of Debrecen
Department Name
Kenézy Gyula Campus, Neurológiai Klinika
Contact Person Name
Pálma Piros
Contact Person Email
pirospalma@gmail.com
Site Name
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Department Name
Department of Neurology
Contact Person Name
Katalin Lugosi
Contact Person Email
lugosikacci@gmail.com
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Neurológiai Osztály
Contact Person Name
Géza Szilágyi
Contact Person Email
szilagyi.geza@uzsoki.hu
Site Name
Semmelweis University
Department Name
Neurológiai Klinika
Contact Person Name
Magdolna Simó

Portugal

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
63
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Centro de Responsabilidade Integrada de Esclerose Múltipla
Contact Person Name
João Sequeira
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Neurologia
Contact Person Name
João Cerqueira
Contact Person Email
2ca@ccabraga.org
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Serviço de Neurologia
Contact Person Name
Manuel Salavisa
Site Name
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Department Name
Serviço de Neurologia
Contact Person Name
Luís Ruano
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Serviço de Neurologia
Contact Person Name
Sónia Batista
Contact Person Email
uid@ulscoimbra.min-saude.pt

Germany

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
6
Number Of Sites
16
Number Of Participants
35

Sites

Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik fuer Neurologie
Contact Person Name
Florian Then Bergh
Site Name
St. Josef-Hospital
Department Name
Studienambulanz
Contact Person Name
Simon Faissner
Contact Person Email
simon.faissner@rub.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Abteilung fuer Neurodegenerative Erkrankungen
Contact Person Name
Antje Giede-Jeppe
Site Name
LMU Klinikum Muenchen AöR
Department Name
Institut fuer Klinische Neuroimmunologie
Contact Person Name
Tania Kuempfel
Site Name
Goethe University Frankfurt
Department Name
Klinik fuer Neurologie
Contact Person Name
Yavor Yalachkov
Contact Person Email
yalachkov@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Zentrum für Neurologie & Klinik für Neuroimmunologie
Contact Person Name
Anne-Katrin Pröbstel
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik fuer Neurologie
Contact Person Name
Sina Rosenkranz
Contact Person Email
s.rosenkranz@uke.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik f. Neurologie mit Institut f.Transl. Neurol
Contact Person Name
Luisa Klotz
Contact Person Email
luisa.klotz@ukmuenster.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fuer Neurologie
Contact Person Name
Hayrettin Tumani
Contact Person Email
hayrettin.tumani@uni-ulm.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Neurologische Klinik
Contact Person Name
Lucas Schirmer
Site Name
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
Department Name
Studienzentrum Neuropoint GmbH
Contact Person Name
Daniela Rau
Contact Person Email
rau@neurologie-ulm.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Neurologische Klinik und Poliklinik
Contact Person Name
Achim Berthele
Contact Person Email
achim.berthele@tum.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Neurologische Klinik
Contact Person Name
Veit Rothhammer
Contact Person Email
veit.rothhammer@uk-erlangen.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Neurologie
Contact Person Name
Refik Pul
Contact Person Email
refik.pul@uk-essen.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Neurologie und Neurophysiologie
Contact Person Name
Rick Dersch
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik fuer Neurologie
Contact Person Name
Orhan Aktas

Spain

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
16
Number Of Sites
22
Number Of Participants
60

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Ana Alonso Torres
Contact Person Email
anaat73@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Contact Person Name
Celia Oreja Guevara
Contact Person Email
orejacbn@gmail.com
Site Name
Hospital Santa Caterina Ias
Department Name
Neurology
Contact Person Name
Gary Alvarez Bravo
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Neurology
Contact Person Name
Jose Eustasio Meca Lallana
Contact Person Email
pmecal@gmail.com
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Neurology
Contact Person Name
Ines Gonzalez Suarez
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurology
Contact Person Name
Vicente Gonzalez Quintanilla
Contact Person Email
vicente.gonzalez@scsalud.es
Site Name
Hospital Clinic De Barcelona
Department Name
Neurology
Contact Person Name
Yolanda Blanco Morgado
Contact Person Email
YBLANCO@clinic.cat
Site Name
Hospital General Universitario De Albacete
Department Name
Neurology
Contact Person Name
Julia Gracia Gil
Contact Person Email
jgraciagil@yahoo.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurology
Contact Person Name
Rafael Arroyo Gonzalez
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Francisco Carlos Perez-Miralles
Contact Person Email
miralles_neuro@hotmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Neurology
Contact Person Name
Jose Maria Prieto Gonzalez
Contact Person Email
josemaoscar.prieto@usc.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Angela Vidal Jordana
Contact Person Email
AVidalJ@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neurology
Contact Person Name
Lucienne Costa-FRossard França
Contact Person Email
lufrossard@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Mar Tintoré Subirana
Contact Person Email
mtintore@cem-cat.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurology
Contact Person Name
Maria Luisa Martinez Gines
Contact Person Email
marisamgines@hotmail.com
Site Name
Bellvitge University Hospital
Department Name
Neurology
Contact Person Name
Sergio Martinez Yelamos
Site Name
Hospital Universitario De Cruces
Department Name
Neurology
Contact Person Name
Alfredo Rodriguez-Antigüedad Zarrantz
Site Name
Hospital Universitario De La Princesa
Department Name
Neurology
Contact Person Name
Virginia Meca Lallana
Contact Person Email
virmeca@hotmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Neurology
Contact Person Name
Francisco Gascon Gimenez
Contact Person Email
fgascongimenez@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Sara Eichau Madueno
Contact Person Email
saraeichau@gmail.com
Site Name
Hospital Del Mar
Department Name
Neurology
Contact Person Name
Jose Enrique Martinez Rodriguez
Contact Person Email
jmartinezr@hmar.cat

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Iqvia Biotech LLC
Responsibilities
CRO, monitoring

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IxRS","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"F. Hoffmann-La Roche AG","duties_or_roles":"For Clinical Genotyping samples & RBR samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"SGS Analytics Switzerland AG","duties_or_roles":"For PK samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"For exploratory biomarkers","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"CRO, monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"For PD 2-AG samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central sample laboratory","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Sysnav","duties_or_roles":"Digital Biomarker","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7268489
Active Substance
RO7268489
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
RO7268489 Placebo
Modality
Other
Investigational Product Name
Ocrevus 300 mg concentrate for solution for infusion
Active Substance
OCRELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation EU/1/17/1231/001 or EU/1/17/1231/002 as listed)
Maximum Dose
600 mg (maxDailyDoseAmount listed)
Combination Treatment
Yes

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