The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and, pharmacodynamics (PD) of subcutaneously administered RO7845860 in participants with relapsing multiple sclerosis (RMS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs)
Time frame: From Baseline up to approximately Week 96
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline up to approximately Week 96
Part 1, 2 and 3: Serum Concentration of RO7845860
Time frame: At prespecified timepoints from Baseline up to approximately Week 96
Part 1, 2 and 3: Percentage of Participants Achieving B-Cell Levels Below the Lower Limit of Quantitation in Blood as per Employed High-Sensitive Flow Cytometry Assay
Time frame: From Baseline up to approximately Week 96
Part 1, 2 and 3: B-Cell Levels Over Time in Blood
Time frame: From Baseline up to approximately Week 96
Parts 1, 2 and 3: Median Time to Repletion of B-Cells in Blood to the Lower Limit of Normal or to the Detection Limit of the B-cell Assays
Time frame: From Baseline up to approximately Week 96
Parts 2 and 3: Change From Baseline in B-Cell Levels in Cerebrospinal Fluid (CSF)
Time frame: From Baseline up to approximately Week 96
Parts 1, 2 and 3: Prevalence and Incidence of Anti-drug Antibodies (ADAs) to RO7845860
Time frame: From Baseline up to approximately Week 96
Reference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.