A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis
NCT ID: NCT03972306
Last Updated: 2025-07-08
Study Results
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Basic Information
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COMPLETED
PHASE1
134 participants
INTERVENTIONAL
2019-08-12
2025-06-03
Brief Summary
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A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Cohorts A1-A4
Participants (participants pretreated with ocrelizumab) will receive a single injection of subcutaneous (SC) ocrelizumab co-mixed with rHuPH20 in the abdomen. For every new dose level, recruitment will be staggered by enrolling 1 participant in each cohort followed by a 48-hour waiting period to review safety and tolerability data by the Safety Monitoring Committee (SMC) prior to enrolling subsequent participants in the same cohort. Currently, the planned dose escalation steps for patients who enroll in Group A are as follows:
* Cohort A1: 40 mg of SC ocrelizumab
* Cohort A2: 200 mg of SC ocrelizumab
* Cohort A3: 600 mg of SC ocrelizumab
* Cohort A4: 1200 mg of SC ocrelizumab
Ocrelizumab
Administered by subcutaneous Injection
rHuPH20
Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
Group A: Cohort A5
In the non-randomized subphase, participants will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen.
Ocrelizumab
Administered by subcutaneous Injection
rHuPH20
Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
Group A: Cohort AA
Participants will receive a single 600-mg dose ocrelizumab by intravenous (IV) infusion
Ocrelizumab
Administered by Intravenous (IV) Injection
Group B: Cohorts B1-B4
Ocrelizumab treatment- naive participants will receive a minimum of 3 patients in Cohort B will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen.
* Cohort B1: 40 mg of SC ocrelizumab
* Cohort B2: 200 mg of SC ocrelizumab
* Cohort B3: 600 mg of SC ocrelizumab
* Cohort B4: 1200 mg of SC ocrelizumab
Ocrelizumab
Administered by subcutaneous Injection
rHuPH20
Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
Interventions
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Ocrelizumab
Administered by subcutaneous Injection
Ocrelizumab
Administered by Intravenous (IV) Injection
rHuPH20
Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Other Identifiers
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CN41144
Identifier Type: -
Identifier Source: org_study_id
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