MedPath

Ocrelizumab

Generic Name
Ocrelizumab
Brand Names
Ocrevus
Drug Type
Biotech
CAS Number
637334-45-3
Unique Ingredient Identifier
A10SJL62JY
Background

Ocrelizumab is a CD20-directed cytolytic antibody indicated for the treatment of patients with primary progressive or relapsing forms of multiple sclerosis (MS). It is a second-generation recombinant humanized monoclonal IgG1 antibody that selectively targets B-cells that express the CD20 antigen. Compared to non-humanized CD20 antibodies such as rituximab, ocrelizumab is expected to be less immunogenic with repeated infusions, improving the benefit-to-risk profile for patients with MS.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that leads to neurological disabilities and a significantly reduced quality of life. Most patients with MS experience episodes of relapses with worsening function, followed by recovery periods or remissions. Primary progressive multiple sclerosis (PPMS) accounts for 10-15% of the overall population of patients with MS, and leads to the gradual worsening of neurologic disability from symptom onset, often without early relapses or remissions .

Developed by Genentech/Roche, ocrelizumab was approved by the FDA in March 2017 under the market name Ocrevus for intravenous injection. It was later approved by Health Canada in August 2017, making the drug the first available treatment for PPMS in both the US and Canada. In clinical trials of patients with relapsing forms of MS, treatment with ocrelizumab resulted in reduced relapse rates and reduced worsening of disability compared to interferon beta-1a. In phase 3 clinical trials of patients with PPMS, treatment with ocrelizumab led to lower clinical and MRI progression rates compared to placebo.

Indication

用于治疗复发型多发性硬化症(MS)。

Associated Conditions
Clinically Isolated Syndrome (CIS), Primary Progressive Multiple Sclerosis (PPMS), Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

Phase 4
Recruiting
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo for Ocrelizumab
First Posted Date
2022-03-18
Last Posted Date
2024-12-05
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
123
Registration Number
NCT05285891
Locations
🇺🇸

Yale School of Medicine, New Haven, Connecticut, United States

🇺🇸

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 8 locations

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2022-03-07
Last Posted Date
2025-03-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1300
Registration Number
NCT05269004
Locations
🇨🇿

Krajska zdravotni a.s. - Nemocnice Teplice o.z., Teplice, Czechia

🇪🇪

West Tallinn Central Hospital, Tallinn, Estonia

🇪🇪

Tartu University Hospital, Tartu, Estonia

and more 231 locations

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

Phase 3
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Interventions
First Posted Date
2022-02-10
Last Posted Date
2025-05-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
236
Registration Number
NCT05232825
Locations
🇮🇹

IRCCS Istituto Neurologico Neuromed, Pozzilli, Molise, Italy

🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

🇨🇿

Fakultni nemocnice u sv. Anny, Brno, Czechia

and more 34 locations

LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2022-01-27
Last Posted Date
2024-05-17
Lead Sponsor
Centre Hospitalier Universitaire de Nice
Target Recruit Count
72
Registration Number
NCT05210621
Locations
🇫🇷

Amiens University Hospital, Amiens, France

🇫🇷

Bayonne Hospital, Bayonne, France

🇫🇷

Caen University Hospital, Caen, France

and more 12 locations

A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis

Phase 4
Withdrawn
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2022-01-26
Last Posted Date
2024-01-23
Lead Sponsor
Hoffmann-La Roche
Registration Number
NCT05208840
Locations
🇷🇺

City Clinical Hospital #24; Multipal Sclerosis department, Moskva, Moskovskaja Oblast, Russian Federation

🇷🇺

National Center of Socially Significant Diseases, Saint-Petersburg, Sankt Petersburg, Russian Federation

Ocrelizumab Access by Socio-Economic Status

Conditions
Multiple Sclerosis
Interventions
First Posted Date
2021-11-23
Last Posted Date
2021-11-23
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
600
Registration Number
NCT05131984
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

Phase 3
Active, not recruiting
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
Other: Ocrelizumab Placebo
Other: Fingolimod Placebo
First Posted Date
2021-11-17
Last Posted Date
2025-04-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
171
Registration Number
NCT05123703
Locations
🇦🇷

Centro de Investigaciones Médicas Tucuman, San Miguel de Tucuman, Argentina

🇫🇷

Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-bicêtre, France

🇮🇹

Universita? G. D'Annunzio, Chieti, Abruzzo, Italy

and more 103 locations

A Systems Approach to Understanding Disease Processes in Multiple Sclerosis

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2021-10-18
Last Posted Date
2024-10-02
Lead Sponsor
Providence Health & Services
Target Recruit Count
14
Registration Number
NCT05081700
Locations
🇺🇸

Providence Neurological Specialties West, Portland, Oregon, United States

🇺🇸

Swedish Medical Center Multiple Sclerosis Center, Seattle, Washington, United States

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

Phase 4
Completed
Conditions
Clinically Isolated Syndrome
Multiple Sclerosis
Interventions
First Posted Date
2021-08-10
Last Posted Date
2025-04-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
26
Registration Number
NCT04998851
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

University Of Colorado, Aurora, Colorado, United States

🇺🇸

Northwestern Memorial Hospital, Chicago, Illinois, United States

and more 5 locations

A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

Phase 4
Active, not recruiting
Conditions
Clinically Isolated Syndrome
Multiple Sclerosis
Interventions
First Posted Date
2021-08-10
Last Posted Date
2025-05-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
70
Registration Number
NCT04998812
Locations
🇨🇭

Inselspital Bern, Bern, Switzerland

🇺🇸

Northwestern Memorial Hospital, Chicago, Illinois, United States

🇪🇸

Hosp. Clinico San Carlos, Madrid, Spain

and more 9 locations
© Copyright 2025. All Rights Reserved by MedPath