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A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis
A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis
CompletedPhase 1
Sponsor: Hoffmann-La Roche
Conditions: Multiple Sclerosis (MS)
Interventions: Ocrelizumab, Ocrelizumab, rHuPH20
Countries: United States
This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).
Eligibility overview
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 * Absence of relapses for 30 days prior to the screening visit * For the dose escalation phase for participants pretreated with ocrelizumab (Group A): treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks) * For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab. * For female perticipants without reproductive potential: Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy). Exclusion Criteria: * MS disease duration of more than 15 years for participants with an Expanded Disability Status Scale (EDSS) score \<2.0 at screening. * Known presence of other neurologic disorders that may mimic MS, including, but not limited to, the following: * History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord * History or known presence of Central Nervous System (CNS) or spinal cord tumor (e.g., meningioma,glioma) * History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency) * History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy. * History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome) * Neuromyelitis optica * History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren syndrome, Behçet disease, sarcoidosis). * History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression
Locations (18)
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Alexandria, Louisiana, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Worcester, Massachusetts, United States
- Detroit, Michigan, United States
- Owosso, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Dayton, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Cordova, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States