Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB033 · 7 trials · 5 indications
A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | This was a follow-up study, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo. |
| BIIB033 100mg/Kg | EXPERIMENTAL | This was a follow-up study, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033. |
| BIIB033, 3 mg/kg | EXPERIMENTAL | BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84. |
| BIIB033, 10 mg/kg | EXPERIMENTAL | BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033, 30 mg/kg | EXPERIMENTAL | BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033, 100 mg/kg | EXPERIMENTAL | BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033 | EXPERIMENTAL | Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses). |
| BIIB033-A | EXPERIMENTAL | Staggered single dosing schema |
| BIIB033-B | EXPERIMENTAL | Staggered single dosing schema |
| Cohort 1 | EXPERIMENTAL | A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1 |
| Cohort 2 | EXPERIMENTAL | A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1 |
| Cohort 3 | EXPERIMENTAL | One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15 |
| Active study drug | EXPERIMENTAL | Treatment |
| Comparator | EXPERIMENTAL | Dummy drug |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered as specified in the treatment arm. |
| BIIB033 100mg/Kg | DRUG | Administered as specified in the treatment arm. |
| BIIB033 | DRUG | - |
| Avonex | DRUG | - |
| BIIB033 (anti-LINGO-1 mAb) | BIOLOGICAL | 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses). |
| BIIB033 (opicinumab) | DRUG | - |
Key Inclusion Criteria: * Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01...
BIIB033 is an investigational monoclonal antibody being studied for central nervous system demyelinating diseases, including multiple sclerosis and acute optic neuritis. It has been evaluated in Phase 2 clinical trials for relapsing-remitting multiple sclerosis and acute optic neuritis, with completed studies involving over 400 participants.
BIIB033 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen has sponsored multiple clinical trials of BIIB033, including Phase 2 studies in multiple sclerosis and acute optic neuritis.
BIIB033 has completed Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA. The completed Phase 2 studies assessed its efficacy, safety, tolerability, and pharmacokinetics in participants with relapsing forms of multiple sclerosis and acute optic neuritis.
BIIB033 has been studied in several completed clinical trials, including NCT01721161 in acute optic neuritis (82 participants), NCT01864148 in relapsing forms of multiple sclerosis (419 participants), NCT02657915 as a long-term remyelinating therapy assessment (52 participants), and NCT02833142 evaluating pharmacokinetics and safety (28 participants).
Yes, BIIB033 is also known as opicinumab. In clinical trial NCT02833142, the drug is referred to as BIIB033 (opicinumab), confirming that both names refer to the same investigational monoclonal antibody being developed by Biogen.
Yes, one completed Phase 1 trial of BIIB033, NCT02833142, enrolled healthy volunteers. This study evaluated the pharmacokinetics, safety, and tolerability of single doses of BIIB033 produced by two manufacturing processes, with 28 participants in the United States.