A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)
NCT ID: NCT07282574
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2026-01-30
2030-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RO7268489 Dose 1 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
RO7268489 Dose 2 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
RO7268489 Dose 3 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Placebo + Ocrelizumab
Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Placebo
Placebo will be administered per schedule as specified in the arms.
Interventions
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RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Placebo
Placebo will be administered per schedule as specified in the arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive
Exclusion Criteria
* Lack of peripheral venous access
* History of alcohol or other drug abuse, in the opinion of the investigator, within 5 years prior to screening
* Inability to complete an magnetic resonance imaging (MRI)
* Contraindications to ocrelizumab mandatory pre-medications
* Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening
18 Years
60 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Central Contacts
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Reference Study ID Number: BP46016 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2025-521636-10-00
Identifier Type: CTIS
Identifier Source: secondary_id
BP46016
Identifier Type: -
Identifier Source: org_study_id
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