Back to search results

Study of a New Subcutaneous Ocrelizumab Formulation for Multiple Sclerosis

This study is testing a new way to give ocrelizumab (a medicine for multiple sclerosis, MS) as an injection under the skin (subcutaneous, SC). The main goal is to see how safe and well-tolerated this new ocrelizumab SC formulation is for people with MS. You may be able to join if you are 18 to 65 years old and have Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) with an EDSS score between 0 and 6.5. The study will start with different doses of ocrelizumab SC to find the best one, and then participants may continue treatment with that dose. The study will track any side effects for up to 168 weeks to see how safe the treatment is. The current recruitment status is unclear.

Study design
This is an interventional study with 75 planned participants. It involves two treatment phases: a dose-escalation phase followed by a dose-continuation phase.
What's involved
Participants will receive ocrelizumab co-formulated with rHuPH20 as a subcutaneous injection according to a specified schedule. The study involves an initial dose-escalation phase and an option to continue treatment in a dose-continuation phase.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to 168 weeks.

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

NCT07667322

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis

Active, Not Recruiting
PHASE1Ages 18–65InterventionalTreatment
Hoffmann-La Roche
~75 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Ocrelizumab Co-formulated With rHuPH20

At a glance

Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs)
Measured over Up to 168 weeks

Conditions

Multiple Sclerosis

Explore related trials

Primary progressive multiple sclerosisRelapsing-Remitting Multiple Sclerosis

NCT07667322

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

    Guadalajara, Jalisco, Mexicono site contact published

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, Brazilno site contact published

  • Hope Neurology

    Knoxville, Tennesseeno site contact published

  • Inovacion y Desarrollo en ciencias de la salud

    Mexico City, Mexico CITY (federal District), Mexicono site contact published

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, Brazilno site contact published

  • John Hopkins University School of Medicine

    Baltimore, Marylandno site contact published

  • Morriston Hospital

    Swansea, United Kingdomno site contact published

  • Neurology Associates, PA

    Maitland, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

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

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening

Exclusion

Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
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
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 (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), 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
Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
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
Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab

What this trial measures

  • Number of Participants With Adverse Events (AEs)Up to 168 weeks