Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG9418 · 2 trials · 2 indications
A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
| Arm | Type | Description |
|---|---|---|
| Avonex Single-Use Autoinjector | EXPERIMENTAL | Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. |
| Interferon beta-1a | EXPERIMENTAL | Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo IM injection twice weekly for 12 weeks |
| Name | Type | Description |
|---|---|---|
| single-use autoinjector with a prefilled liquid Avonex syringe | DEVICE | - |
| Avonex prefilled syringe via manual IM injection | DEVICE | - |
| BG9418 (interferon beta-1a) | DRUG | - |
| Placebo | DRUG | Placebo IM injection, self-administered per protocol. |
Inclusion Criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Must be 18 to 65 years old, inclusive, at t...
BG9418 is an investigational small molecule being developed by Biogen Inc. for active ulcerative colitis and multiple sclerosis. It is currently in clinical development and has not been approved by the FDA. The drug is being studied for its potential to treat these conditions.
BG9418 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen is conducting clinical trials to evaluate the safety and efficacy of BG9418 for the treatment of active ulcerative colitis and multiple sclerosis.
BG9418 is in Phase 2 clinical development. It has completed one Phase 2 trial for active ulcerative colitis and one Phase 3 trial for multiple sclerosis. The drug remains investigational and has not received FDA approval for any indication.
BG9418 has been studied in two completed clinical trials. NCT00616434 was a Phase 2, randomized, double-blind, placebo-controlled study in 123 patients with active ulcerative colitis. NCT00828204 was a Phase 3 study in 95 multiple sclerosis patients evaluating the Avonex single-use autoinjector.
BG9418 is associated with Avonex, which is interferon beta-1a. The clinical trials listed for BG9418 include studies of Avonex in ulcerative colitis and multiple sclerosis. However, BG9418 is the investigational drug name, while Avonex is a brand name for interferon beta-1a.