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Monoclonal Antibodies

High-Dose Ocrelizumab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expanded disability status scale (EDSS) score from 0 to 5.5 inclusive at screening and baseline
Diagnosis of relapsing multiple sclerosis (RMS) in accordance with the revised McDonald Criteria 2017
Must not have
Concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 4.3 years
Awards & highlights

Summary

This trial is testing a higher dose of ocrelizumab, given every 24 weeks, to see if it is more effective than the current 600 mg dose, in people with RMS. The trial will also look at safety and how the body processes the drug.

Who is the study for?
Adults with Relapsing Multiple Sclerosis (RMS) who've had at least one or two relapses in the past year or two, have an EDSS score of 0-5.5, and stable neurological condition for 30 days before the trial. Women must use contraception if of childbearing potential. Exclusions include those with certain immunodeficiencies, recent drug abuse, cancer history within 10 years, or previous treatments that could interfere with results.
What is being tested?
The study is testing a higher dose of Ocrelizumab given every 24 weeks to see if it's more effective than the approved lower dose for RMS treatment. It's randomized and double-blind, meaning neither participants nor researchers know who gets which dose until after the trial ends.
What are the potential side effects?
Ocrelizumab may cause infusion reactions like rash or fever; infections due to weakened immune response; and potentially serious brain infection called PML. Methylprednisolone can increase blood sugar levels and cause mood swings while antihistamines might lead to drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability level is moderate or less.
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I have been diagnosed with relapsing multiple sclerosis.
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I've had at least 2 relapses in the last 2 years or 1 in the last year with none in the last 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need long-term steroids or immunosuppressants for another health issue.
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I haven't taken fingolimod, siponimod, or ozanimod in the last 6 weeks.
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I have or might have had a brain infection called PML.
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I cannot have an MRI or use contrast dye due to health reasons.
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I do not have any neurological disorders that could affect MS diagnosis or treatment assessment.
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I have been diagnosed with primary progressive multiple sclerosis.
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My immune system is weakened.
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I have had an organ transplant or received anti-rejection medication.
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I have not taken systemic corticosteroids in the last 4 weeks.
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I have not had IV immunoglobulin or plasmapheresis in the last 12 weeks.
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I have had a bone marrow or stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 4.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 4.3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Onset of 12-week cCDP (cCDP12)
Secondary study objectives
B-cell levels in blood
Change in NfL at Week 48 for patients assigned to the approved dose ocrelizumab group
Change in NfL at Week 48 for patients assigned to the higher dose ocrelizumab group
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ocrelizumab Higher DoseExperimental Treatment3 Interventions
Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Group II: Ocrelizumab Approved DoseActive Control3 Interventions
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 4
~7260
Antihistamine
2016
Completed Phase 3
~240
Methylprednisolone
2015
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,092,258 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,169 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
891,552 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,495 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04544436 — Phase 3
Multiple Sclerosis Research Study Groups: Ocrelizumab Approved Dose, Ocrelizumab Higher Dose
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04544436 — Phase 3
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544436 — Phase 3
~36 spots leftby Dec 2024
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