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Also known as BG00002-E (natalizumab high titer)
BG00002-E · 1 trial · 1 indication
Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.
| Arm | Type | Description |
|---|---|---|
| Natalizumab High Titer | EXPERIMENTAL | natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses |
| Name | Type | Description |
|---|---|---|
| BG00002-E (natalizumab high titer) | BIOLOGICAL | - |
Inclusion Criteria: * Diagnosis of a relapsing form of MS * Must fall within the therapeutic indications stated in the locally approved label for natalizumab * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Prior treatment with natalizumab * Considered by investigator t...
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BG00002-E is an investigational monoclonal antibody developed by Biogen Inc. (ticker BIIB) for multiple sclerosis. It is also known as BG00002-E (natalizumab high titer). It was studied in a Phase 2 trial evaluating immunogenicity and safety in patients with multiple sclerosis.
BG00002-E was studied for use in multiple sclerosis, a neurological condition. The Phase 2 trial NCT00516893 evaluated its immunogenicity and safety in adults with multiple sclerosis. It is an investigational agent and is not an approved treatment for multiple sclerosis.
BG00002-E is developed by Biogen Inc., which trades under the ticker BIIB. Biogen sponsored the Phase 2 trial NCT00516893, titled Natalizumab High Titer Immunogenicity and Safety, which enrolled 113 participants with multiple sclerosis in the United States.
BG00002-E is in Phase 2 development. Its only listed trial, NCT00516893, is a completed Phase 2 study. BG00002-E is investigational and has not been approved by the FDA for multiple sclerosis or any other indication.
BG00002-E has been studied in one clinical trial, NCT00516893, titled Natalizumab High Titer Immunogenicity and Safety. This completed Phase 2 trial enrolled 113 adults aged 18 years and older with multiple sclerosis in the United States. It was an uncontrolled study without randomization or blinding.
Yes, BG00002-E is also known as BG00002-E (natalizumab high titer). Both names refer to the same investigational monoclonal antibody developed by Biogen Inc. (ticker BIIB) for multiple sclerosis. The Phase 2 trial NCT00516893 studied this agent in 113 participants.