Ocrelizumab for Multiple Sclerosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple Sclerosis+2 More
Ocrelizumab - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of a higher dose of ocrelizumab to the current approved dose in people with PPMS.

Eligible Conditions
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 22 Secondary · Reporting Duration: Baseline up to approximately 4.3 years

Year 3
1. Reduction in cCDP sustained for at least 12 weeks, measured by time to onset of cCDP sustained for at least 12 weeks.
Annual Rate of Change from Baseline in Multiple Sclerosis Impact Scale /MSIS-29) Physical Scale
Annual Rate of Percent Change from Baseline in Total Brain Volume
Change from Baseline in the Multiple Sclerosis Impact Scale (MSIS 29) Score
Change in B-cell Levels in Blood
Levels of Blood B-cells
Levels of Interleukin-6 (IL-6) in Blood
Lymphocyte
Levels of Neurofilament Light Chain (NfL) in Blood
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood
Time to 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT)
Time to >/= 20% Increase in 12-week Confirmed by 9-Hole Peg Test (9-HPT)
Time to >/= 20% Increase in 12-week Confirmed by Timed 25-Foot Walk Test (T25FWT)
Time to >/= 20% Increase in 24-week Confirmed T25FWT
Time to >/= 20% Increase in 24-week Confirmed by 9-HPT
Time to Onset of 12-week CDP (CDP12)
Time to Onset of 24-week CDP (CDP24)
Time to Onset of 24-week cCDP (cCDP24)
Baseline, week 120
Change from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical scale at Week 120
Week 0
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood in Participants with the High versus Low Affinity Fcgamma Receptor 3A (FcgR3A) Genotype per Arm
Week 0
Proportion of Participants with Different DNA Genotypes
Week 0
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Week 0
Serum Concentration of Ocrelizumab at Specified Timepoints

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ocrelizumab
43%Infusion related reaction
14%Urinary tract infection
11%Nasopharyngitis
10%Fatigue
9%Headache
9%Upper respiratory tract infection
6%Pain in extremity
6%Sinusitis
5%Nausea
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02637856) in the Ocrelizumab ARM group. Side effects include: Infusion related reaction with 43%, Urinary tract infection with 14%, Nasopharyngitis with 11%, Fatigue with 10%, Headache with 9%.

Trial Design

2 Treatment Groups

Ocrelizumab Approved Dose
1 of 2
Ocrelizumab Higher Dose
1 of 2

Active Control

Experimental Treatment

699 Total Participants · 2 Treatment Groups

Primary Treatment: Ocrelizumab · No Placebo Group · Phase 3

Ocrelizumab Higher DoseExperimental Group · 3 Interventions: Antihistamine, Ocrelizumab, Methylprednisolone · Intervention Types: Drug, Drug, Drug
Ocrelizumab Approved DoseActiveComparator Group · 3 Interventions: Antihistamine, Ocrelizumab, Methylprednisolone · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antihistamine
2008
Completed Phase 2
~80
Ocrelizumab
FDA approved
Methylprednisolone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately 4.3 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,353 Previous Clinical Trials
1,093,338 Total Patients Enrolled
31 Trials studying Multiple Sclerosis
16,578 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,135 Previous Clinical Trials
900,832 Total Patients Enrolled
33 Trials studying Multiple Sclerosis
16,876 Patients Enrolled for Multiple Sclerosis

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands.
The Expanded Disability Status Scale (EDSS) score at screening and baseline, from 3 to 6.5 inclusive.
You have an average 9HPT score of at least 250 seconds on two or more trials with each hand at baseline and at screening.
You have a score of 2.0 or greater on the Functional Systems scale for the pyramidal system that was due to lower extremity findings at screening and baseline.
You have a T25FWT score over 150 seconds.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Washington University School of Medicine50.0%
Hotel-Dieu de Levis50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%