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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to approximately 6.5 years
Awards & highlights

Summary

This trial is testing a new drug, ocrelizumab, on people with RMS or PPMS. The trial will last for 4.5 years, and participants will be given infusions of the drug every few weeks. The trial will test the effects of the drug on the participants' symptoms and on their biomarkers.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to approximately 6.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 6.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Other outcome measures
Change in Levels of NfL in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Change in Number of CD19+ B cells in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Ocrelizumab Levels in CSF
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: RMS Cohort Arm 4: Ocrelizumab + LPExperimental Treatment4 Interventions
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group II: RMS Cohort Arm 3: Ocrelizumab + LPExperimental Treatment4 Interventions
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group III: RMS Cohort Arm 2: Ocrelizumab + LPExperimental Treatment4 Interventions
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group IV: RMS Cohort Arm 1: Ocrelizumab + LPExperimental Treatment4 Interventions
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group V: PPMS Cohort: Ocrelizumab + LPExperimental Treatment4 Interventions
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methyloprednisolone
2016
Completed Phase 3
~140
Ocrelizumab
2016
Completed Phase 3
~5770
Lumbar Puncture
2016
Completed Phase 3
~510
Antihistamine
2016
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,542 Previous Clinical Trials
567,946 Total Patients Enrolled
26 Trials studying Multiple Sclerosis
4,616 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
890,175 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,228 Patients Enrolled for Multiple Sclerosis
~14 spots leftby Jul 2025
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