Relapsing Multiple Sclerosis
Conditions
Brief summary
1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12
Detailed description
1. Total number of new or enlarging T2- weighted lesions observed on brain MRI at Weeks 4, 8, and 12, 2. Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12, 3. Incidence and severity of adverse events, 4. Change from baseline in vital signs, 5. Change from baseline in targeted clinical laboratory test results, 6. Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale, 7. Plasma concentration of fenebrutinib at specified timepoints
Interventions
None listed
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number of new or enlarging T2- weighted lesions observed on brain MRI at Weeks 4, 8, and 12, 2. Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12, 3. Incidence and severity of adverse events, 4. Change from baseline in vital signs, 5. Change from baseline in targeted clinical laboratory test results, 6. Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale, 7. Plasma concentration of fenebrutinib at specified timepoints | — |
Countries
Croatia, Czechia, Slovakia
Outcome results
None listed