A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
Hoffmann-La Roche
Summary
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start * Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening Exclusion Criteria: * Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening * Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count…
Interventions
- DrugOcrelizumab Test Formulation
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
- DrugOcrelizumab Reference Formulation
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
Locations (56)
- Profound Research, LLCCarlsbad, California
- Advanced Neurology of Colorado, LLCFort Collins, Colorado
- Neurology Associates PAMaitland, Florida
- University of South FloridaTampa, Florida
- Johns Hopkins University School Of MedicineBaltimore, Maryland
- University of Massachusetts Medical SchoolWorcester, Massachusetts