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Also known as BG00010 (Neublastin), BG00010 IV, Neublastin
BG00010 · 4 trials · 4 indications
QST; Vibratory, Cool Thermal,
| Arm | Type | Description |
|---|---|---|
| BG00010 | EXPERIMENTAL | Administered as an IV injection at various dose levels 3 times per week for 1 week |
| Placebo | PLACEBO_COMPARATOR | Matched placebo IV injection 3 times per week for 1 week |
| Single Ascending Dose (SAD): BG00010 | EXPERIMENTAL | Up to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart. |
| SAD: Placebo | EXPERIMENTAL | Up to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart. |
| Multiple Ascending Dose (MAD): BG00010 | EXPERIMENTAL | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010. |
| Multiple Ascending Dose (MAD): Placebo | EXPERIMENTAL | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo. |
| BG00010 (Neublastin) | EXPERIMENTAL | Participants may be randomized to escalating doses of BG00010 |
| Name | Type | Description |
|---|---|---|
| BG00010 | DRUG | As specified in the treatment arm |
| Placebo | DRUG | As specified in the treatment arm |
| BG00010 IV | BIOLOGICAL | Ascending Doses intravenous (IV) of BG00010 |
| BG00010 SC | BIOLOGICAL | Ascending Doses subcutaneous (SC) of BG00010 |
| Placebo IV | DRUG | Ascending Doses intravenous (IV) of Placebo |
| Placebo SC | DRUG | Ascending Doses subcutaneous (SC) of placebo |
| BG00010 (Neublastin) | DRUG | Multiple doses, weight-based IV administration |
Key Inclusion Criteria: * Body weight ≤133 kg. * Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization. * Objective, documented evidence of painful lumbar ra...
BG00010 is being developed for painful lumbar radiculopathy and sciatica, conditions in which nerve root compression causes radiating leg pain. It is an investigational therapy and has not been approved for any indication. Biogen studied it in adults aged 18 years and older across Phase 1 and Phase 2 clinical trials.
BG00010 is developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the clinical program evaluating the drug in sciatica and painful lumbar radiculopathy, including a Phase 2 adaptive-design trial and several Phase 1 studies conducted in the United States, the Netherlands, and Australia.
BG00010 reached Phase 2 clinical development. The Phase 2 trial, NCT01873404, was a multiple-dose adaptive-design study in participants with painful lumbar radiculopathy, and it has been completed. BG00010 remains an investigational drug and is not FDA approved for any indication.
BG00010 has been studied in completed trials including NCT01873404, a Phase 2 multiple-dose adaptive-design trial in painful lumbar radiculopathy with 183 participants, and Phase 1 studies NCT01842126, NCT01405833, and NCT00961766. These trials enrolled adults with sciatica, painful lumbar radiculopathy, or healthy volunteers, and all have completed.
Yes. BG00010 is also known as Neublastin, and the intravenous formulation has been referred to as BG00010 IV. These names refer to the same investigational Biogen compound studied in sciatica and painful lumbar radiculopathy, so search results using either name describe the same drug program.
Across the reported BG00010 studies, total enrollment was 237 participants. The Phase 2 trial NCT01873404 enrolled 183 adults with painful lumbar radiculopathy, while the Phase 1 studies NCT01842126, NCT01405833, and NCT00961766 enrolled 54, 56, and 48 participants respectively. The trials were randomized, double-blind, and controlled.