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

Running, not enrolling · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT07074886

Run by

Hoffmann-La Roche

People needed

193

Starts

2025-11-13

Expected to finish

2030-03-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Profound Research, LLC — Carlsbad, California, United States
• Advanced Neurology of Colorado, LLC — Fort Collins, Colorado, United States
• Neurology Associates PA — Maitland, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Johns Hopkins University School Of Medicine — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Hope Neurology — Knoxville, Tennessee, United States
• Swedish Medical Center — Seattle, Washington, United States
• Centro de Especialidades Neurológicas y Rehabilitación - CENyR — CABA, Buenos Aires, Argentina
• Focus CECIC — CABA, CABA / Buenos Aires, Argentina
• INECO Neurociencias Orono — Rosario, Santa Fe Province, Argentina
• IME - Instituto Médico Especializado — Buenos Aires, Argentina
• Centro de Investigacion en Enfermedades Reumaticas CIER — Ciudad Autonoma Buenos Aires, Argentina
• Sanatorio del Sur S.A. — San Miguel de Tucumán, Argentina
• Santa Casa de Misericordia de Salvador — Salvador, Estado de Bahia, Brazil
• Instituto de Neurologia de Curitiba — Curitiba, Paraná, Brazil
• Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda — Porto Alegre, Rio Grande do Sul, Brazil
• Instituto do Cerebro do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil
• Clinica Neurológica e Neurocirúrgica de Joinville — Joinville, Santa Catarina, Brazil
• Centro de Pesquisas Clinicas - CPCLIN — São Paulo, São Paulo, Brazil
• Hôpital Guillaume et René Laënnec — Nantes, France
• CHU de Nimes - Hopital Universitaire Caremeau — Nîmes, France
• Charite - Universitätsmedizin Berlin — Berlin, Germany
• St. Josef-Hospital, Klinik für Neurologie — Bochum, Germany

Full record on ClinicalTrials.gov

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