Natalizumab

Generic Name
Natalizumab
Brand Names
Tysabri, Tyruko
Drug Type
Biotech
Chemical Formula
-
CAS Number
189261-10-7
Unique Ingredient Identifier
3JB47N2Q2P
Background

Natalizumab is a recombinant humanized IgG4κ monoclonal antibody that binds to α4-integrin. While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the market for mu...

Indication

Natalizumab is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
...

Associated Conditions
Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), Severe Crohn's Disease, Moderate Crohn’s Disease
Associated Therapies
-

A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)

Active, not recruiting
Conditions
Interventions
First Posted Date
2023-06-29
Last Posted Date
2024-08-23
Lead Sponsor
Biogen
Target Recruit Count
400
Registration Number
NCT05925049
Locations
🇺🇸

Research Site, Cambridge, Massachusetts, United States

A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants

Active, not recruiting
Conditions
Interventions
First Posted Date
2023-01-27
Last Posted Date
2024-06-14
Lead Sponsor
Biogen
Target Recruit Count
34
Registration Number
NCT05701423
Locations
🇩🇪

Klinik für Neurologie, Universitätsklinikum Düsseldorf, Düsseldorf, Germany

Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

First Posted Date
2022-11-16
Last Posted Date
2024-10-07
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
10
Registration Number
NCT05618301
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2022-09-08
Last Posted Date
2024-06-21
Lead Sponsor
Biogen
Target Recruit Count
1
Registration Number
NCT05532163
Locations
🇩🇪

Neurologische Studiengesellschaft Bonn GbR, Bonn, Germany

🇩🇪

Neurologische Praxis Dr. med. Boris-Alexander Kallmann, Bamberg, Germany

A Study for Tysabri Participant Preference

First Posted Date
2022-03-31
Last Posted Date
2024-05-17
Lead Sponsor
Biogen
Target Recruit Count
318
Registration Number
NCT05304520
Locations
🇩🇪

Katholisches Klinikum Bochum gGmbH, Bochum, Germany

🇩🇪

Neurologie am Mexikoplatz, Berlin, Germany

🇩🇪

Neurologie Neu-Ulm, Neu-Ulm, Germany

and more 37 locations

A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2022-03-03
Last Posted Date
2024-07-05
Lead Sponsor
Biogen
Target Recruit Count
21
Registration Number
NCT05265728
Locations
🇯🇵

National Center of Neurology and Psychiatry, Kodaira-shi, Japan

🇯🇵

St.Marianna University Hospital, Kawasaki-shi, Japan

🇯🇵

Chiba University Hospital, Chiba-shi, Japan

and more 9 locations

TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants

Recruiting
Conditions
Interventions
First Posted Date
2022-02-11
Last Posted Date
2024-07-17
Lead Sponsor
Biogen
Target Recruit Count
600
Registration Number
NCT05236777
Locations
🇨🇿

Všeobecná fakultní nemocnice v Praze, Prague, Czechia

🇨🇿

Nemocnice Teplice, Teplice, Czechia

🇨🇿

Fakultní nemocnice Brno, Brno, Czechia

and more 12 locations

Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab

First Posted Date
2021-07-16
Last Posted Date
2022-03-24
Lead Sponsor
Multiple Sclerosis Center of Northeastern New York
Target Recruit Count
42
Registration Number
NCT04964700
Locations
🇺🇸

Multiple Sclerosis Center of Northeastern New York, P.C., Latham, New York, United States

Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

First Posted Date
2021-04-05
Last Posted Date
2024-02-05
Lead Sponsor
Biogen
Target Recruit Count
60
Registration Number
NCT04832399
Locations
🇵🇹

Research Site, Vila Nova de Gaia, Portugal

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