Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05798520 | 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 (MS) | PHASE2 | COMPLETED | 127 | — | — | Jul 25, 2023 | Feb 10, 2026 | Feb 20, 2026 | 77 | United States, Bulgaria +8 |
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 ...