Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB068 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohorts 1 | EXPERIMENTAL | 6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet |
| Cohort 2 | EXPERIMENTAL | 6 participants randomized (4:2) to receive a SAD administered orally in tablet(s) |
| Cohort 3 | EXPERIMENTAL | 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) |
| Cohort 4 | EXPERIMENTAL | 8 participants randomized (6:2) to receive a SAD administered orally in tablet |
| Cohort 5 | EXPERIMENTAL | 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) |
| Cohort 6 | EXPERIMENTAL | 14 participants (all active) to receive a SAD administered orally in tablet(s) |
| Name | Type | Description |
|---|---|---|
| BIIB068 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm |
Key Inclusion Criteria: * All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment. * All female...
BIIB068 is an investigational small molecule being developed by Biogen Inc. for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and tolerability.
BIIB068 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The drug is a small molecule in Phase 1 clinical development for Systemic Lupus Erythematosus (SLE).
BIIB068 is in Phase 1 clinical development. It is an investigational drug, meaning it is not FDA approved and is still being studied in clinical trials. The Phase 1 trial for BIIB068 has been completed.
BIIB068 has one completed clinical trial, identified as NCT02829541. This was a Phase 1, single-ascending-dose study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BIIB068 in healthy participants. The trial enrolled 36 participants and was conducted in the United States.
No alternative names for BIIB068 have been reported. The drug is known only as BIIB068, an investigational small molecule developed by Biogen Inc. for Systemic Lupus Erythematosus (SLE).