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)

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Phase 3
Not yet recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Remibrutinib oral treatment
First Posted Date
2025-02-26
Last Posted Date
2025-04-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
360
Registration Number
NCT06846281

A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)

Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2025-01-17
Last Posted Date
2025-05-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
349
Registration Number
NCT06780150
Locations
🇩🇪

Jüdisches Krankenhaus Berlin, Berlin, Germany

🇩🇪

Dres. Lippert/Kausch, Bogen, Germany

🇩🇪

Neurologie im Ulrichshaus Magdeburg, Magdeburg, Germany

and more 50 locations

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Phase 3
Recruiting
Conditions
Relapsing-remitting Multiple Sclerosis (RRMS)
Interventions
First Posted Date
2024-11-22
Last Posted Date
2025-05-15
Lead Sponsor
Amgen
Target Recruit Count
444
Registration Number
NCT06700343
Locations
🇺🇸

Profound Research - Neurology Center of Southern California, Carlsbad, California, United States

🇺🇸

Mountain Neurological Research Center, Basalt, Colorado, United States

🇺🇸

Advanced Neurosciences Research, Llc, Fort Collins, Colorado, United States

and more 18 locations

IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis

Phase 1
Suspended
Conditions
Multiple Sclerosis
Primary Progressive Multiple Sclerosis (PPMS)
Secondary Progressive Multiple Sclerosis (SPMS)
Non-Active Secondary Progressive Multiple Sclerosis
Non-Active SPMS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Interventions
First Posted Date
2024-11-07
Last Posted Date
2025-04-30
Lead Sponsor
Indapta Therapeutics, INC.
Target Recruit Count
34
Registration Number
NCT06677710
Locations
🇺🇸

Stanford University, Stanford, California, United States

🇺🇸

University of Colorado Hospital, Aurora, Colorado, United States

🇺🇸

AdventHealth Orlando - Adventist Health System/Sunbelt, Inc., Orlando, Florida, United States

and more 2 locations

An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

Phase 3
Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2024-11-06
Last Posted Date
2025-05-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
500
Registration Number
NCT06675955
Locations
🇩🇪

Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz, Westerstede, Germany

🇩🇪

Deutsche Klinik für Diagnostik, Wiesbaden, Germany

🇫🇷

Groupe Hospitalier Pellegrin, Bordeaux, France

and more 8 locations

Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis

Phase 4
Recruiting
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2024-07-10
Last Posted Date
2025-02-12
Lead Sponsor
University of California, San Francisco
Target Recruit Count
5
Registration Number
NCT06495593
Locations
🇺🇸

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

WOE of Anti-CD20 Therapies

Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2023-11-07
Last Posted Date
2025-03-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
150
Registration Number
NCT06121349
Locations
🇺🇸

Novartis Investigational site, East Hanover, New Jersey, United States

Impact of Annual Versus Biannual Infusions of Ocrelizumab in Patients With Active MS,After 2 Years of Initial Treatment, on Freedom From Radiological Disease Activity at Two Years: a Multicenter Randomized Controlled Non-inferiority Trial

Phase 3
Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2023-08-21
Last Posted Date
2023-11-28
Lead Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Target Recruit Count
244
Registration Number
NCT05999604
Locations
🇫🇷

Fondation Adolphe de Rothschild, Paris, France

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

First Posted Date
2023-01-18
Last Posted Date
2025-01-30
Lead Sponsor
Biogen
Target Recruit Count
1178
Registration Number
NCT05688436
Locations
🇺🇸

OptumInsight, Eden Prairie, Minnesota, United States

B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis

Phase 4
Recruiting
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2022-03-25
Last Posted Date
2022-04-28
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
296
Registration Number
NCT05296161
Locations
🇳🇱

Amsterdam UMC, location VU, Amsterdam, Noord-Holland, Netherlands

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