A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Hoffmann-La Roche
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
