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 of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

Phase 2
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2019-08-30
Last Posted Date
2025-03-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
23
Registration Number
NCT04075266
Locations
🇮🇹

Ospedale Pediatrico Bambino Gesù, Roma, Lazio, Italy

🇮🇹

Azienda Ospedaliera Sant'Andrea, Roma, Lazio, Italy

🇮🇹

AOU Policlinico V. Emanuele - P.O G. Rodolico, Catania, Sicilia, Italy

and more 9 locations

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis, Primary Progressive
Interventions
Drug: Placebo
First Posted Date
2019-07-29
Last Posted Date
2025-04-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1000
Registration Number
NCT04035005
Locations
🇧🇬

Multiprofile Hospital For Active Treatment Avis Medica, Pleven, Bulgaria

🇧🇬

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD, Sofia, Bulgaria

🇫🇷

CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, France

and more 156 locations

A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

Phase 1
Active, not recruiting
Conditions
Multiple Sclerosis (MS)
Interventions
First Posted Date
2019-06-03
Last Posted Date
2025-03-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
134
Registration Number
NCT03972306
Locations
🇺🇸

University of Colorado, Aurora, Colorado, United States

🇺🇸

Georgetown University Medical Center, Washington, District of Columbia, United States

🇺🇸

University of South Florida School of Medicine Morsani Center for Advanced Health Care, Tampa, Florida, United States

and more 17 locations

Ocrelizumab Effects on the Metabolome in MS

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2019-03-13
Last Posted Date
2023-12-12
Lead Sponsor
Johns Hopkins University
Target Recruit Count
25
Registration Number
NCT03873389
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Short-term B-cell Depletion in Relapsing Multiple Sclerosis

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2019-02-26
Last Posted Date
2025-02-05
Lead Sponsor
Johns Hopkins University
Target Recruit Count
10
Registration Number
NCT03853746
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Efficacy of Ocrelizumab in Autoimmune Encephalitis

Phase 2
Terminated
Conditions
Autoimmune Encephalitis
Interventions
Drug: Saline
First Posted Date
2019-02-11
Last Posted Date
2021-10-19
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
3
Registration Number
NCT03835728
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM

Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-12-24
Last Posted Date
2019-08-09
Lead Sponsor
Hospital Italiano de Buenos Aires
Target Recruit Count
100
Registration Number
NCT03784547
Locations
🇦🇷

Juan Ignacio Rojas, Buenos Aires, Argentina

🇦🇷

Edgard Carnero, Buenos Aires, Argentina

Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714

Phase 3
Recruiting
Conditions
Multiple Sclerosis
Relapse
Primary Progressive Multiple Sclerosis
Interventions
First Posted Date
2018-10-01
Last Posted Date
2023-09-06
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
51
Registration Number
NCT03691077
Locations
🇫🇷

Hôpital Saint-Antoine - Service de Neurologie, Paris, France

A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-07-30
Last Posted Date
2020-06-29
Lead Sponsor
Genentech, Inc.
Target Recruit Count
141
Registration Number
NCT03606460
Locations
🇺🇸

Dragonfly Research, LLC, Wellesley, Massachusetts, United States

🇺🇸

University of Colorado; Anschutz Medical Campus Department of Neurology, Aurora, Colorado, United States

🇺🇸

Cleveland Clinic Fndn, Cleveland, Ohio, United States

and more 2 locations

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-07-26
Last Posted Date
2025-04-01
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1500
Registration Number
NCT03599245
Locations
🇧🇷

Instituto de Neurologia de Curitiba, Curitiba, Paraná, Brazil

🇧🇷

Hospital Sao Lucas - PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil

🇧🇷

Hospital das Clinicas - FMUSP, Sao Paulo, São Paulo, Brazil

and more 158 locations
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