Clinical trial • Neurology
Ocrelizumab for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Active secondary progressive multiple sclerosis
Clinical trial of Ocrelizumab for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Active secondary progressive multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Active secondary progressive multiple sclerosis
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 30-01-2025
- First CTIS Authorization Date
- 01-06-2025
Trial design
Ocrevus (ocrelizumab) — comparator; dose/schedule not specified in the provided record-controlled trial across 22 sites in Croatia, Bulgaria, Poland.
- Comparator
- Ocrevus (ocrelizumab) — comparator; dose/schedule not specified in the provided record
- Target Sample Size
- 126
- Trial Duration For Participant
- 1423
Eligibility
Recruits 126 Vulnerable population selected; consent/assent handling not specified in the provided record..
- Vulnerable Population
- Vulnerable population selected; consent/assent handling not specified in the provided record.
Recruitment
- Planned Sample Size
- 126
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 126
Croatia
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 227
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Opca Bolnica Varazdin
- Department Name
- Department of Neurology
- Principal Investigator Name
- Spomenka Kidjemet-Piskac
- Principal Investigator Email
- spomenka.piskac@obv.hr
- Contact Person Name
- Spomenka Kidjemet-Piskac
- Contact Person Email
- spomenka.piskac@obv.hr
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Department of Neurology
- Principal Investigator Name
- Mario Habek
- Principal Investigator Email
- mario.habek@mef.hr
- Contact Person Name
- Mario Habek
- Contact Person Email
- mario.habek@mef.hr
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 09-04-2025
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 223
- Number Of Sites
- 8
- Number Of Participants
- 29
Sites
- Site Name
- Acibadem City Clinic Tokuda University Hospital EAD
- Department Name
- Neurology and Sleep Medicine Clinic
- Principal Investigator Name
- Ivan Staikov
- Principal Investigator Email
- ivanstaikov@hotmail.com
- Contact Person Name
- Ivan Staikov
- Contact Person Email
- ivanstaikov@hotmail.com
- Site Name
- Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD
- Principal Investigator Name
- Kostadin Barzinski
- Principal Investigator Email
- dr_kburzinski@abv.bg
- Contact Person Name
- Kostadin Barzinski
- Contact Person Email
- dr_kburzinski@abv.bg
- Site Name
- Medical Center Academica 2008 EOOD
- Principal Investigator Name
- Plamen Tsvetanov
- Principal Investigator Email
- tzvetanovplamen@hotmail.com
- Contact Person Name
- Plamen Tsvetanov
- Contact Person Email
- tzvetanovplamen@hotmail.com
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Nervous Diseases Clinic for Locomotor Disorders
- Principal Investigator Name
- Ivan Milanov
- Principal Investigator Email
- milanovivan@yahoo.com
- Contact Person Name
- Ivan Milanov
- Contact Person Email
- milanovivan@yahoo.com
- Site Name
- Medical Center Medica 2005 EOOD
- Principal Investigator Name
- Valentina Ignatova – Valkova
- Principal Investigator Email
- Valyaig@abv.bg
- Contact Person Name
- Valentina Ignatova – Valkova
- Contact Person Email
- Valyaig@abv.bg
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Principal Investigator Name
- Krasimir Genov
- Principal Investigator Email
- kr_genov@abv.bg
- Contact Person Name
- Krasimir Genov
- Contact Person Email
- kr_genov@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Nervous Diseases Clinic
- Principal Investigator Name
- Penka Atanasova
- Principal Investigator Email
- prof.penka.atanasova@gmail.com
- Contact Person Name
- Penka Atanasova
- Contact Person Email
- prof.penka.atanasova@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Department Name
- Nervous Diseases Clinic
- 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
Poland
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 322
- Number Of Sites
- 12
- Number Of Participants
- 90
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Karolina Piasecka-Stryczyńska
- Principal Investigator Email
- kpe@poczta.onet.pl
- Contact Person Name
- Karolina Piasecka-Stryczyńska
- Contact Person Email
- kpe@poczta.onet.pl
- Site Name
- Ma-Lek Clinical Sp. z o.o.
- Department Name
- Ma-Lek Centrum Terapii SM
- Principal Investigator Name
- Katarzyna Maciejowska
- Principal Investigator Email
- k.maciejowska@ctsm.pl
- Contact Person Name
- Katarzyna Maciejowska
- Contact Person Email
- k.maciejowska@ctsm.pl
- Site Name
- Zanamed Medical Clinic Sp. z o.o.
- Principal Investigator Name
- Małgorzata Kulka
- Principal Investigator Email
- Malgorzata.kulka@zanmed.pl
- Contact Person Name
- Małgorzata Kulka
- Contact Person Email
- Malgorzata.kulka@zanmed.pl
- Site Name
- Neurocentrum Bydgoszcz Sp. z o.o.
- Principal Investigator Name
- Paweł Bochniak
- Principal Investigator Email
- p.bochniak@ncbydgoszcz.pl
- Contact Person Name
- Paweł Bochniak
- Contact Person Email
- p.bochniak@ncbydgoszcz.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
- Neuro-Medic Sp. z o.o.
- Department Name
- Neuro-Medic Poradnia Wielospecjalistyczna
- Principal Investigator Name
- Janusz Zbrojkiewicz
- Principal Investigator Email
- jzbrojkiewicz@op.pl
- Contact Person Name
- Janusz Zbrojkiewicz
- Contact Person Email
- jzbrojkiewicz@op.pl
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
- Principal Investigator Name
- Marcin Nastaj
- Principal Investigator Email
- marcinnastaj@gmail.com
- Contact Person Name
- Marcin Nastaj
- Contact Person Email
- marcinnastaj@gmail.com
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Oddział Neurologiczny
- Principal Investigator Name
- Monika Adamczyk-Sowa
- Principal Investigator Email
- neurozab@sum.edu.pl
- Contact Person Name
- Monika Adamczyk-Sowa
- Contact Person Email
- neurozab@sum.edu.pl
- Site Name
- Euromedis Sp. z o.o.
- Principal Investigator Name
- Marcin Ratajczak
- Principal Investigator Email
- marcin.ratajczak@euromedis.pl
- Contact Person Name
- Marcin Ratajczak
- Contact Person Email
- marcin.ratajczak@euromedis.pl
- Site Name
- Ilkowski I Partnerzy sp.p. Lekarzy
- Department Name
- NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
- Principal Investigator Name
- Jan Ilkowski
- Principal Investigator Email
- jan.ilkowski@neurokard.pl
- Contact Person Name
- Jan Ilkowski
- Contact Person Email
- jan.ilkowski@neurokard.pl
- Site Name
- Centrum Medyczne Neuroprotect
- Department Name
- Centrum Medyczne NeuroProtect
- Principal Investigator Name
- Anna Karlińska
- Principal Investigator Email
- anna.karlinska@neuroprotect.pl
- Contact Person Name
- Anna Karlińska
- Contact Person Email
- anna.karlinska@neuroprotect.pl
- Site Name
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Agata Kłósek
- Principal Investigator Email
- klosek@twojaprzychodnia.com
- Contact Person Name
- Agata Kłósek
- Contact Person Email
- klosek@twojaprzychodnia.com
Sponsor
Primary sponsor
- Full Name
- H e x a l AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- CYB704
- Active Substance
- Ocrelizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
- Authorisation Status
- Investigational (proposed biosimilar)
- Investigational Product Name
- Ocrevus (ocrelizumab)
- Active Substance
- Ocrelizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
- Authorisation Status
- Authorised (approved product)
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