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)

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

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2020-09-16
Last Posted Date
2025-03-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
769
Registration Number
NCT04548999
Locations
🇵🇱

COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika, Gdansk, Poland

🇵🇱

MA-LEK Clinical Sp. Z o.o., Katowice, Poland

🇵🇱

Szpital Specjalistyczny im. Rydygiera w Krakowie, Krakow, Poland

and more 146 locations

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

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2020-09-10
Last Posted Date
2025-04-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
864
Registration Number
NCT04544436
Locations
🇵🇱

Osrodek Badan Klinicznych Euromedis, Szczecin, Poland

🇵🇱

Centrum Medyczne NeuroProtect, Warszawa, Poland

🇵🇱

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie, Warszawa, Poland

and more 118 locations

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis, Primary Progressive
Interventions
Drug: Placebo matched to ocrelizumab
Drug: Placebo matched to fenebrutinib
First Posted Date
2020-09-10
Last Posted Date
2025-03-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
985
Registration Number
NCT04544449
Locations
🇦🇷

Fundacion Rosarina de Neurorehabilitacion, Rosario, Argentina

🇧🇬

UMHAT Dr. Georgi Stranski, Pleven, Bulgaria

🇨🇴

Instituto Neurologico de Colombia INDEC, Medellin, Colombia

and more 186 locations

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

Phase 4
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Interventions
First Posted Date
2020-07-10
Last Posted Date
2025-01-08
Lead Sponsor
University of California, San Francisco
Target Recruit Count
30
Registration Number
NCT04466150
Locations
🇺🇸

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

Mechanistic Study of Ocrevus

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2020-07-07
Last Posted Date
2024-05-31
Lead Sponsor
University of Michigan
Target Recruit Count
35
Registration Number
NCT04459988
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI

Recruiting
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2020-06-26
Last Posted Date
2024-02-14
Lead Sponsor
Kessler Foundation
Target Recruit Count
60
Registration Number
NCT04448977
Locations
🇺🇸

Kessler Foundation, West Orange, New Jersey, United States

Effects of Ocrevus in Relapsing Multiple Sclerosis

Phase 4
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Platform
First Posted Date
2020-05-14
Last Posted Date
2025-04-04
Lead Sponsor
Georgia State University
Target Recruit Count
60
Registration Number
NCT04387734
Locations
🇺🇸

Multiple Sclerosis Center of Atlanta, Atlanta, Georgia, United States

🇺🇸

Georgia State University, Atlanta, Georgia, United States

Ocrelizumab in Breastmilk

Completed
Conditions
Clinically Isolated Syndrome
Multiple Sclerosis
Interventions
First Posted Date
2020-05-13
Last Posted Date
2022-12-16
Lead Sponsor
University of California, San Francisco
Target Recruit Count
30
Registration Number
NCT04387110
Locations
🇺🇸

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

Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab

Phase 4
Active, not recruiting
Conditions
Multiple Sclerosis, Relapsing
Interventions
First Posted Date
2020-05-06
Last Posted Date
2025-04-24
Lead Sponsor
Genentech, Inc.
Target Recruit Count
179
Registration Number
NCT04377555
Locations
🇺🇸

SUNY Upstate Medical Center, Syracuse, New York, United States

🇺🇸

Neurology Specialists, Inc, Dayton, Ohio, United States

🇵🇷

Centro Internacional De Mercadeo, Guaynabo, Puerto Rico

and more 29 locations

Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis

Phase 4
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2020-02-10
Last Posted Date
2025-02-17
Lead Sponsor
Johns Hopkins University
Target Recruit Count
10
Registration Number
NCT04261790
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

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