NCT07074886

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

A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ocrelizumab Test Formulation	Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
DRUG	Ocrelizumab Reference Formulation	Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2025-11-13
• Primary completion: 2027-01-31
• Completion: 2030-10-30
• First posted: 2025-07-20
• Last updated: 2026-03-30

Locations

56 sites across 9 countries: United States, Argentina, Brazil, France, Germany, Italy, Mexico, Poland, Spain

Regulatory

• FDA-regulated drug study