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Comparing two subcutaneous ocrelizumab formulations for people with multiple sclerosis

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

Phase 2 Interventional Hoffmann-La Roche · NCT07074886

This study will test whether a new subcutaneous ocrelizumab formulation works the same as the marketed subcutaneous ocrelizumab for adults with relapsing or primary progressive multiple sclerosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment182 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsocrelizumab, alemtuzumab
Locations56 sites (Carlsbad, California and 55 other locations)
Trial IDNCT07074886 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional bioequivalence study compares a test subcutaneous formulation of ocrelizumab to the marketed subcutaneous reference formulation. In a controlled phase, participants receive a single dose of either the test or reference formulation, after which all participants enter a continuation phase and receive the test formulation. The primary focus is on pharmacokinetic bioequivalence and safety/tolerability following subcutaneous administration. Eligible participants meet MS diagnostic criteria and range from EDSS 0 to 6.5 at screening.

Who should consider this trial

Good fit: Adults with relapsing or primary progressive MS who meet McDonald diagnostic criteria, have an EDSS of 0–6.5, and have not received anti-CD20 therapy within the prior two years are ideal candidates.

Not a fit: People who recently received anti-CD20 drugs, are immunocompromised, have recent cancer or a history of PML, or are sensitive to ocrelizumab ingredients are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, it could support an alternative subcutaneous ocrelizumab option with comparable effects that may expand delivery choices for patients.

How similar studies have performed: Intravenous ocrelizumab is well established and subcutaneous formulations of other anti-CD20 antibodies (for example rituximab) have been developed successfully, but direct bioequivalence of an ocrelizumab SC test formulation is being specifically tested here.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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)

Where this trial is running

Carlsbad, California and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.