clinical trial · NCT07074886
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Multiple SclerosisOcrelizumab Test FormulationOcrelizumab Reference Formulation
brief 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.
started
Nov 13, 2025
primary completion
Jan 31, 2027
completion
Oct 30, 2030
last updated
Apr 27, 2026
official title
A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol