Last updated 13 days ago
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)
360 patients around the world
Available in Spain, Brazil
Hoffmann-La Roche
1Research sites
360Patients around the world
This study is for people with
Multiple Sclerosis
Requirements for the patient
To 60 Years
All Gender
Medical requirements
- PMS, in accordance with the revised 2017 McDonald criteria.Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive.Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit.
- MS relapse during the 6 months preceding the randomization date.Lack of peripheral venous access.History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening.Inability to complete a magnetic resonance imaging (MRI).Contraindications to ocrelizumab mandatory pre-medications.Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening.
Sites
CPClin – Centro de Pesquisas Clinicas LTDA
Recruiting
StudyMintaka
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Multiple Sclerosis
Requirements
To 60 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07282574
