A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

Running, not enrolling · Phase 3

Conditions studied: Multiple Sclerosis

In brief

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Key facts

Study ID

NCT04548999

Run by

Hoffmann-La Roche

People needed

769

Starts

2020-12-03

Expected to finish

2027-09-08

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PPMS
• EDSS score at screening and baseline, from 3 to 6.5 inclusive
• Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
• Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds
• Score of ≥ to 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline
• Documented magnetic resonance imaging (MRI) of brain with abnormalities consistent with MS
• Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization
• Participants must be neurologically stable for at least 30 days prior to randomization and baseline
• Disease duration from the onset of MS symptoms; if EDSS score at screening is ≤ 5, disease duration must be less than 10 years; If EDSS score at screening is > 5, disease duration must be less than 15 years
• Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands
• Females of childbearing potential: agreement to remain abstinent or use adequate contraceptive methods
• Female participants, without reproductive potential may be enrolled e.g. if post-menopausal or if surgically sterile

You may not qualify if…

• History of relapsing remitting or secondary progressive MS at screening
• Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening
• History of confirmed or suspected progressive multifocal leukoencephalopathy
• History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
• Immunocompromised state
• Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
• Inability to complete an MRI or contraindication to gadolinium administration
• Contraindications to mandatory pre-medications for infusion-related reaction (IRRs)
• Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Significant, uncontrolled disease that may preclude participant from participating in the study
• History of or currently active primary or secondary, non-drug-related, immunodeficiency
• Pregnant or breastfeeding or intending to become pregnant
• Lack of peripheral venous access
• History of alcohol or other drug abuse within 12 months prior to screening
• Treatment with any investigational agent or treatment with any experimental procedure for MS
• Previous use of anti-cluster of differentiation 20 (CD20s) (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy
• Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
• Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
• Previous treatment with natalizumab within 4.5 months of baseline
• Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
• Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication
• Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
• Any previous history of transplantation or anti-rejection therapy
• Treatment with IV immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization

Where it is running

• 21st Century Neurology — Phoenix, Arizona, United States
• University of California Irvine — Irvine, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Advanced Neurosciences Research LLC — Fort Collins, Colorado, United States
• MS and Neuromuscular Center of Excellence — Clearwater, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Baptist Health Lexington — Nicholasville, Kentucky, United States
• International Neurorehabilitation Institute — Lutherville, Maryland, United States
• Massachusetts General Hospital. — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Jersey Shore University Medical Centre — Neptune City, New Jersey, United States
• Northwell Health — Great Neck, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Neurology Clinic PC — Cordova, Tennessee, United States
• Advanced Neurosciences Institute — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Lone Star Neurology of San Antonio — San Antonio, Texas, United States
• Texas Institute for Neurological Disorders — Sherman, Texas, United States
• Wheaton Franciscan Healthcare - St. Francis Outpatient Center — Milwaukee, Wisconsin, United States
• CEMIC Saavedra — Buenos Aires, Argentina
• Alabama Neurology Associates — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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