Ocrelizumab Test Formulation
DrugOcrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Other names: RO4964913
NCT Number: NCT07074886
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Centro de Especialidades Neurológicas y Rehabilitación - CENyR, CABA, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Other names: RO4964913
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
Other names: RO4964913
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 168 weeks
Hoffmann-La Roche
Industry
A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
Acronym: PORTAMENTO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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