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

NCT07074886 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2027-01-31
Completion
2030-10-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074886 on ClinicalTrials.gov