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OpenTrials
Completed

NCT Number: NCT03972306

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Drug

Administered by subcutaneous Injection

rHuPH20

Drug

Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab

Primary outcomes

  1. Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following subcutaneous (SC) administration

    Time frame: At predefined intervals from baseline through end of study (approximately 5 years)

  2. Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following single IV (intravenous Infusion)administration

    Time frame: At predefined intervals from baseline through end of study (approximately 5 years)

  3. Percentage of participants with adverse events

    Time frame: Baseline to end of study (approximately 5 years)

  4. Percentage of participants with change from baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters

    Time frame: Baseline to end of study (approximately 5 years)

  5. Incidence of local pain at site of injection assessed using Visual Analog Scale (VAS

    Time frame: Baseline to end of study (approximately 5 years)

  6. Incidence of local-injection reaction (ISR) assessed using Local Injection-Site Symptom Assessment (LISSA)

    Time frame: Baseline to end of study (approximately 5 years)

Secondary outcomes

  1. Percentage of Participants with Anti-Drug Antibodies (ADAs) to ocrelizumab

    Time frame: Baseline to end of study (approximately 5 years)

  2. Percentage of Participants with Anti-Drug Antibodies (ADAs) to rHuPH20

    Time frame: Baseline to end of study (approximately 5 years)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2019
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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