Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG00002 · 1 trial · 1 indication
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.
For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.
'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.
| Arm | Type | Description |
|---|---|---|
| Natalizumab | EXPERIMENTAL | All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480. |
| Name | Type | Description |
|---|---|---|
| BG00002 (natalizumab) | BIOLOGICAL | - |
Inclusion Criteria: * MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging \[MRI\] scan) * Considered by the investigator to be free of signs a...
BG00002 is a monoclonal antibody being developed for the treatment of relapsing-remitting multiple sclerosis, a form of multiple sclerosis characterized by episodes of new or worsening symptoms followed by periods of recovery. It is currently in Phase 3 clinical development for this indication.
BG00002 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with relapsing-remitting multiple sclerosis.
BG00002 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of relapsing-remitting multiple sclerosis, and its development is ongoing.
BG00002 has been studied in a Phase 3 clinical trial with the identifier NCT00306592, titled "Natalizumab Re-Initiation of Dosing." This trial enrolled 404 participants with relapsing-remitting multiple sclerosis and was conducted in the United States and Canada. The trial has been completed.
BG00002 is the drug being evaluated in a clinical trial titled "Natalizumab Re-Initiation of Dosing." The trial investigates the re-initiation of dosing with natalizumab, which suggests that BG00002 may be natalizumab itself. However, the drug is also referred to by the code name BG00002 in development.