Clinical trial • Phase II • Neurology | Immunology
OCRELIZUMAB for Multiple sclerosis
Phase II trial of OCRELIZUMAB for Multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology | Immunology
- Trial Disease
- Multiple sclerosis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 20-08-2025
- First CTIS Authorization Date
- 05-12-2025
Trial design
Randomised, open-label, ocrevus / ocrevus 920 mg solution for injection (ocrelizumab) — 920 mg; subcutaneous (comparator formulation). schedule not specified in the ctis record.-controlled Phase II trial across 36 sites in France, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Ocrevus / Ocrevus 920 mg solution for injection (ocrelizumab) — 920 mg; subcutaneous (comparator formulation). Schedule not specified in the CTIS record.
- Target Sample Size
- 96
Eligibility
Recruits 96 adults.
- Pregnancy Exclusion
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab.
Inclusion criteria
- {"criterion_text":"- Age 18−65 years, inclusive, at the time of signing Informed Consent Form"}
- {"criterion_text":"- Diagnosis of relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start"}
- {"criterion_text":"- Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening"}
- {"criterion_text":"- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab."}
- {"criterion_text":"- For female participants without childbearing potential: – Female participants may be enrolled if postmenopausal"}
Exclusion criteria
- {"criterion_text":"- Participants who have previously received anti-CD20s (including ocrelizumab) less than 2 years before screening"}
- {"criterion_text":"- Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: – B-cell count is below lower limit of normal (LLN), or – The discontinuation of the treatment was due to safety reasons"}
- {"criterion_text":"- Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening"}
- {"criterion_text":"- History of or currently active primary or secondary (non−drug-related) immunodeficiency"}
- {"criterion_text":"- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)"}
- {"criterion_text":"- Previous treatment with cladribine, atacicept, and alemtuzumab"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary PK parameters of ocrelizumab: area under the serum concentration−time curve over the first 12 weeks post-dose (AUC0-12W) and maximum serum concentration observed (Cmax)","definition_or_measurement_approach":"Measurement of serum pharmacokinetics: area under the serum concentration−time curve over the first 12 weeks post-dose (AUC0-12W) and observed maximum serum concentration (Cmax)."}
Secondary endpoints
- {"endpoint_text":"- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 grading scale","definition_or_measurement_approach":"Adverse events will be recorded and graded using NCI CTCAE v5.0 to determine incidence and severity."}
- {"endpoint_text":"- Change from baseline in selected vital signs","definition_or_measurement_approach":"Change from baseline measurements of specified vital signs (not further specified in the CTIS record)."}
- {"endpoint_text":"- Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in selected clinical laboratory parameters (specific labs not detailed in the CTIS record)."}
Recruitment
- Planned Sample Size
- 96
- Recruitment Window Months
- 47
- Consent Approach
- Written informed consent is required from participants (age eligibility 18–65). Subject information and informed consent form (L1_SIS and ICF) documents are present in the CTIS record for the study; protocol/public titles and materials have translations (e.g., Spanish, French, Polish). No explicit details on assent or guardian consent are provided in the CTIS data.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 86
France
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 181
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Neurologie
- 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 Nantes
- Department Name
- Neurologie
- Principal Investigator Name
- Sandrine Wiertlewski
- Principal Investigator Email
- sandrine.wiertlewski@chu-nantes.fr
- Contact Person Name
- Sandrine Wiertlewski
- Contact Person Email
- sandrine.wiertlewski@chu-nantes.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Neurologie
- Principal Investigator Name
- Jerôme De Seze
- Principal Investigator Email
- Jerome.DESEZE@chru-strasbourg.fr
- Contact Person Name
- Jerôme De Seze
- Contact Person Email
- Jerome.DESEZE@chru-strasbourg.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 165
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Neurologische Klinik
- 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 Tuebingen AöR
- Department Name
- Zentrum für Neurologie
- Principal Investigator Name
- Markus Kowarik
- Principal Investigator Email
- Markus.Kowarik@med.uni-tuebingen.de
- Contact Person Name
- Markus Kowarik
- Contact Person Email
- Markus.Kowarik@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Zentrum für klinische Neurowissenschaften
- Principal Investigator Name
- Tjalf Ziemssen
- Principal Investigator Email
- Tjalf.Ziemssen@ukdd.de
- Contact Person Name
- Tjalf Ziemssen
- Contact Person Email
- Tjalf.Ziemssen@ukdd.de
- Site Name
- Ruhr University
- 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
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für 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
Italy
- Earliest CTIS Part Ii Submission Date
- 24-09-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 209
- Number Of Sites
- 9
- Number Of Participants
- 25
Sites
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- I Division of Neurology and Neurophysiopathology
- Principal Investigator Name
- Antonio Gallo
- Principal Investigator Email
- antonio.gallo@unicampania.it
- Contact Person Name
- Antonio Gallo
- Contact Person Email
- antonio.gallo@unicampania.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- II Clinica Neurologica
- Principal Investigator Name
- Elisabetta Signoriello
- Principal Investigator Email
- elisabetta.signoriello@gmail.com
- Contact Person Name
- Elisabetta Signoriello
- Contact Person Email
- elisabetta.signoriello@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- SC Neurologia
- 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 Policlinico Universitario Tor Vergata
- Department Name
- Dip. Neuroscienze-Clinica Neurologica UOSD 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
- Istituto Neurologico Mediterraneo Neuromed S.p.A.
- Department Name
- Neurology
- Principal Investigator Name
- Diego Centonze
- Principal Investigator Email
- centonze@uniroma2.it
- Contact Person Name
- Diego Centonze
- Contact Person Email
- centonze@uniroma2.it
- Site Name
- Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l.
- Department Name
- Neurologia
- Principal Investigator Name
- Carlo Pozzilli
- Principal Investigator Email
- carlo.pozzilli@uniroma1.it
- Contact Person Name
- Carlo Pozzilli
- Contact Person Email
- carlo.pozzilli@uniroma1.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
- Principal Investigator Name
- Laura Brambilla
- Principal Investigator Email
- laura.brambilla@istituto-besta.it
- Contact Person Name
- Laura Brambilla
- Contact Person Email
- laura.brambilla@istituto-besta.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- additional site address (Via Sergio Pansini 5)
- Principal Investigator Name
- Elisabetta Signoriello
- Principal Investigator Email
- elisabetta.signoriello@gmail.com
- Contact Person Name
- Elisabetta Signoriello
- Contact Person Email
- elisabetta.signoriello@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- I Division of Neurology and Neurophysiopathology (alternate address)
- Principal Investigator Name
- Antonio Gallo
- Principal Investigator Email
- antonio.gallo@unicampania.it
- Contact Person Name
- Antonio Gallo
- Contact Person Email
- antonio.gallo@unicampania.it
Spain
- Earliest CTIS Part Ii Submission Date
- 06-11-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 172
- Number Of Sites
- 10
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurología
- Principal Investigator Name
- Xavier Montalbán Gairín
- Principal Investigator Email
- xavier.montalban@cem-cat.org
- Contact Person Name
- Xavier Montalbán Gairín
- Contact Person Email
- xavier.montalban@cem-cat.org
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Neurología
- Principal Investigator Name
- Jose Meca Lallana
- Principal Investigator Email
- jose.meca@carm.es
- Contact Person Name
- Jose Meca Lallana
- Contact Person Email
- jose.meca@carm.es
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Neurología
- Principal Investigator Name
- Julia Gracia Gil
- Principal Investigator Email
- jgraciagil@yahoo.es
- Contact Person Name
- Julia Gracia Gil
- Contact Person Email
- jgraciagil@yahoo.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurología
- Principal Investigator Name
- Lucienne Costa-Frossard
- Principal Investigator Email
- lufrossard@yahoo.es
- Contact Person Name
- Lucienne Costa-Frossard
- Contact Person Email
- lufrossard@yahoo.es
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Neurología
- Principal Investigator Name
- Ayoze Nauzet González
- Principal Investigator Email
- angonherb@gobiernodecanarias.org
- Contact Person Name
- Ayoze Nauzet González
- Contact Person Email
- angonherb@gobiernodecanarias.org
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Neurología
- Principal Investigator Name
- Rafael Arroyo González
- Principal Investigator Email
- rafaelarroyo09@gmail.com
- Contact Person Name
- Rafael Arroyo González
- Contact Person Email
- rafaelarroyo09@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurología
- Principal Investigator Name
- Sara Eichau Madueño
- Principal Investigator Email
- saraeichau@gmail.com
- Contact Person Name
- Sara Eichau Madueño
- Contact Person Email
- saraeichau@gmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Neurología
- Principal Investigator Name
- Ángel Pérez Sempere
- Principal Investigator Email
- aperezs@mac.com
- Contact Person Name
- Ángel Pérez Sempere
- Contact Person Email
- aperezs@mac.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Neurología
- Principal Investigator Name
- Virginia Meca Lallana
- Principal Investigator Email
- virmeca@hotmail.com
- Contact Person Name
- Virginia Meca Lallana
- Contact Person Email
- virmeca@hotmail.com
- Site Name
- Hospital Universitario De La Princesa (additional site entry)
- Department Name
- Neurología
- Principal Investigator Name
- Virginia Meca Lallana
- Principal Investigator Email
- virmeca@hotmail.com
- Contact Person Name
- Virginia Meca Lallana
- Contact Person Email
- virmeca@hotmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 06-11-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 169
- Number Of Sites
- 9
- Number Of Participants
- 19
Sites
- Site Name
- ProNeuro Centrum Medyczne
- Principal Investigator Name
- Ewa Krzystanek
- Principal Investigator Email
- biuro@proneuro.pl
- Contact Person Name
- Ewa Krzystanek
- Contact Person Email
- biuro@proneuro.pl
- Site Name
- Centrum Neurologii Krzysztof Selmaj
- Principal Investigator Name
- Krzysztof Selmaj
- Principal Investigator Email
- centrum.neurologii.k.selmaj@gmail.com
- Contact Person Name
- Krzysztof Selmaj
- Contact Person Email
- centrum.neurologii.k.selmaj@gmail.com
- Site Name
- Neurocentrum Bydgoszcz Sp. z o.o.
- Principal Investigator Name
- Robert Bonek
- Principal Investigator Email
- rejestracja@ncbydgoszcz.pl
- Contact Person Name
- Robert Bonek
- Contact Person Email
- rejestracja@ncbydgoszcz.pl
- Site Name
- IBISMED Wielospecjalistyczne Centrum Medyczne
- Principal Investigator Name
- Monika Adamczyk-Sowa
- Principal Investigator Email
- cm@ibismed.pl
- Contact Person Name
- Monika Adamczyk-Sowa
- Contact Person Email
- cm@ibismed.pl
- Site Name
- Szpital Uniwersytecki w Krakowie
- Department Name
- Poradnia Neurologiczna
- Principal Investigator Name
- Agnieszka Słowik
- Principal Investigator Email
- pwrona@su.krakow.pl
- Contact Person Name
- Agnieszka Słowik
- Contact Person Email
- pwrona@su.krakow.pl
- Site Name
- Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
- Principal Investigator Name
- Magdalena Boczarska-Jedynak
- Principal Investigator Email
- info@instytutboczarska.pl
- Contact Person Name
- Magdalena Boczarska-Jedynak
- Contact Person Email
- info@instytutboczarska.pl
- Site Name
- Nmedis Sp. z o.o.
- Principal Investigator Name
- Iwona Rościszewska-Żukowska
- Principal Investigator Email
- badaniakliniczne@nmedis.pl
- Contact Person Name
- Iwona Rościszewska-Żukowska
- Contact Person Email
- badaniakliniczne@nmedis.pl
- Site Name
- Nmedis Sp. z o.o. (additional entry)
- Principal Investigator Name
- Iwona Rościszewska-Żukowska
- Principal Investigator Email
- badaniakliniczne@nmedis.pl
- Contact Person Name
- Iwona Rościszewska-Żukowska
- Contact Person Email
- badaniakliniczne@nmedis.pl
- Site Name
- ProNeuro Centrum Medyczne (additional entry)
- Principal Investigator Name
- Ewa Krzystanek
- Principal Investigator Email
- biuro@proneuro.pl
- Contact Person Name
- Ewa Krzystanek
- Contact Person Email
- biuro@proneuro.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- 4G Clinical B.V.
- Responsibilities
- IxRS Provider
- Name
- Fortrea Inc.
- Responsibilities
- Home healthcare
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Central Laboratory Provider
- Name
- Cenetron Diagnostics Ltd.
- Responsibilities
- Central Clinical trial supply
- Name
- Adelphi Values Limited
- Responsibilities
- Patient interviews (Applicable to Spain and Germany)
Third parties
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"IxRS Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Denmark","full_name":"Unilabs A/S","duties_or_roles":"In case of suspected PML","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Home healthcare","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Event Planner","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"EDSS licence and rater certification","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Adelphi Values Limited","duties_or_roles":"Patient interviews (Applicable to Spain and Germany)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cenetron Diagnostics Ltd.","duties_or_roles":"Central Clinical trial supply","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ocrevus, Ocrelizumab
- Active Substance
- OCRELIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Maximum Dose
- 0 (DF dosage form)
- Investigational Product Name
- Ocrevus
- Active Substance
- OCRELIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Starting Dose
- 920 mg
- Maximum Dose
- 3680 mg
- Investigational Product Name
- Ocrevus 920 mg solution for injection
- Active Substance
- OCRELIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Marketing authorisation: EU/1/17/1231/003
- Starting Dose
- 920 mg
- Maximum Dose
- 3680 mg
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