Clinical Trial

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Study acronym: PORTAMENTO
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Enrollment closed, study ongoing 2026-08-07
notable Trial sites reduced: 56 -> 50 locations 2026-08-07
notable Primary completion moved earlier: 2027-01-31 -> 2026-09-17 2026-08-07
minor Completion moved earlier: 2030-10-30 -> 2030-03-31 2026-08-07
notable Trial sites expanded: 41 -> 56 locations 2026-03-31
Trial Details
NCT Number NCT07074886
Lead Sponsor Hoffmann-La Roche
Conditions Multiple Sclerosis
Enrollment 193 participants
Start Date 2025-11-13
Primary Completion 2026-09-17 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-06