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Ocrelizumab Formulations for Multiple Sclerosis Study

This study is looking at two different ways to give ocrelizumab (a medication for multiple sclerosis) through an injection under the skin (subcutaneous or SC). The main goal is to see if a new ocrelizumab SC formulation works the same way in your body as the currently available ocrelizumab SC. This is called "bioequivalence." You could join if you are between 18 and 65 years old and have relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). You cannot have received certain other MS medications (anti-CD20s, including ocrelizumab) before. The study will measure how much ocrelizumab is in your blood over 12 weeks to see if the two formulations are similar. About 182 people are expected to participate.

Study design
This interventional study will involve participants receiving either the test or reference ocrelizumab formulation in the first phase, followed by all participants receiving the test formulation in a continuation phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your blood levels of ocrelizumab will be measured for up to 12 weeks after your dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07074886

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

Active, Not Recruiting
PHASE2Ages 18–65InterventionalTreatment
Hoffmann-La Roche
~193 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Ocrelizumab Test FormulationOcrelizumab Reference Formulation

At a glance

Recruiting sites
0 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab
Measured over Up to 12 weeks
+1 more outcome measured

Conditions

Multiple Sclerosis

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Multiple Sclerosis

Where it's being run

50 sites across 31 states
Spain6
Poland5
Germany4
Argentina3
Florida2
Rio Grande do Sul2
France2
Campania2

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening

Exclusion

Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening
Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons
History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
Immunocompromised state
Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
Lack of peripheral venous access
Previous treatment with cladribine, atacicept, and alemtuzumab
Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
Any previous history of transplantation or anti-rejection therapy
Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)

What this trial measures

  • Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of OcrelizumabUp to 12 weeks
  • Maximum Serum Concentration (Cmax) of OcrelizumabUp to 12 weeks