A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

Completed · Phase 1

Conditions studied: Multiple Sclerosis (MS)

In brief

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).

Key facts

Study ID

NCT03972306

Run by

Hoffmann-La Roche

People needed

134

Starts

2019-08-12

Expected to finish

2025-06-03

Last updated by the study team

2025-07-08

Who can join

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

You may qualify 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
• 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).

You may not qualify if…

• 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

Where it is running

• University of Colorado — Aurora, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• The NeuroMedical Clinic of Central Louisiana — Alexandria, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• John Hopkins University School of Medicine — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis — Owosso, Michigan, United States
• Washington Univ School of Med — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic Mellen Center — Cleveland, Ohio, United States
• UC Health Neurology — Dayton, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Neurology Clinic PC — Cordova, Tennessee, United States
• University of Texas at Houston — Houston, Texas, United States
• Swedish Neuroscience Institute — Seattle, Washington, United States
• MultiCare Health System Institute for Research and Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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