Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational monoclonal antibody being developed for painful lumbar radiculopathy and sciatica. It has been studied in clinical trials for these pain conditions, including a Phase 2 study in participants with painful lumbar radiculopathy. The drug is not approved and remains in clinical development.
BG00010 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen has sponsored clinical trials evaluating the safety, tolerability, and pharmacokinetics of BG00010 in patients with sciatica and painful lumbar radiculopathy.
BG00010 is in Phase 2 clinical development. A Phase 2 multiple dose adaptive design study in participants with painful lumbar radiculopathy has been completed. The drug is investigational and has not been approved by regulatory authorities. Earlier Phase 1 studies have also been completed.
BG00010 has been studied in four completed clinical trials. These include NCT00961766 and NCT01405833, Phase 1 studies in sciatica participants, NCT01842126, a Phase 1 subcutaneous dose study, and NCT01873404, a Phase 2 study in painful lumbar radiculopathy. All trials are completed.
Yes, BG00010 is also known as Neublastin. Clinical trial titles refer to BG00010 (Neublastin) in studies for sciatica and painful lumbar radiculopathy. The drug is a monoclonal antibody being developed by Biogen Inc. for these pain conditions.