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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

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.

Locations (20)

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
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil