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

Hoffmann-La Roche
NCT IDNCT07074886ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

182

Study length

about 5 years

Ages

18–65

Locations

9 sites in CA, CO, FL +5

About this study

Researchers are testing whether a new ocrelizumab formulation is the same as the existing one when given under the skin. The trial will involve two phases: a controlled phase where participants receive either the new or existing formulation, and a continuation phase where all participants receive the new formulation.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Ocrelizumab Reference Formulation
  • 2.Take Ocrelizumab Test Formulation
PhasePhase 2
DrugOcrelizumab Test Formulation
Routeinjection
Primary goalMaximum Serum Concentration (Cmax) of Ocrelizumab

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low9%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Drug routes

injection (Injection)

Endpoints

Primary: Maximum Serum Concentration (Cmax) of Ocrelizumab

Secondary: Number of Participants With Adverse Events (AEs)

Body systems

Neurology