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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

NCT03972306

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