Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-BIIB091
BIIB091 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Part 1: BIIB091 High Dose + Matching Placebo for DRF | EXPERIMENTAL | Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks. |
| Part 1: BIIB091 Low Dose + Matching Placebo for DRF | EXPERIMENTAL | Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks. |
| Part 1: DRF + Matching Placebo for BIIB091 | ACTIVE_COMPARATOR | Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks. |
| Part 2: BIIB091 + DRF Standard Dose | EXPERIMENTAL | Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks. |
| Part 2: BIIB091 + DRF Low Dose | EXPERIMENTAL | Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks. |
| Part 2: DRF + Matching Placebo for BIIB091 | ACTIVE_COMPARATOR | Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks. |
| Name | Type | Description |
|---|---|---|
| BIIB091 | DRUG | Administered as specified in the treatment arm. |
| DRF | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: 1. Diagnosis of RMS \[relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)\] in accordance with the 2017 Revised McDonald criteria. 2. Time since MS symptom onset is \<20 years. 3. Must have expanded disability status scale ...
BIIB091 is an investigational small molecule being studied for the treatment of relapsing forms of multiple sclerosis (MS). It is designed to address brain inflammation associated with MS. The drug is in Phase 2 clinical development and has not been approved for any indication.
BIIB091 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker symbol BIIB. Biogen is the sponsor of the clinical program evaluating the drug in relapsing forms of multiple sclerosis.
BIIB091 is in Phase 2 clinical development. The Phase 2 trial has been completed. The drug remains investigational and has not received regulatory approval for any indication.
BIIB091 has been evaluated in one Phase 2 clinical trial, NCT05798520, titled a study to learn about the safety of BIIB091 and its effect on brain inflammation when taken alone or with diroximel fumarate (DRF) in adults with relapsing forms of multiple sclerosis. The trial is completed and enrolled 127 participants.
Yes, [14C]-BIIB091 is an alternative name for BIIB091. The carbon-14 labeled form is used in certain studies, but both refer to the same investigational drug candidate being developed by Biogen for relapsing forms of multiple sclerosis.
BIIB091 is a small molecule. Its mechanism of action has not been publicly disclosed. It is being studied for its effect on brain inflammation in relapsing forms of multiple sclerosis, but the specific molecular target is not available.