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Label indication PLEGRIDY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. PLEGRIDY is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive… FDA label
Also known as BIIB017 (peginterferon beta-1a), BIIB017 (PEGylated Interferon Beta-1a), Plegridy, peginterferon beta-1a, PEGylated interferon beta-1a, PEG IFN β-1a, BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
BIIB017 · 3 trials · 2 indications
A multiple sclerosis (MS) relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
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, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (\< 4 versus ≥ 4), baseline age (\< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
| Arm | Type | Description |
|---|---|---|
| BIIB017 (peginterferon beta-1a) | EXPERIMENTAL | Participants will receive subcutaneous (SC) injection of BIIB017 (peginterferon beta-1a) 63 microgram (μg) on Day 1, followed by 94 μg at Week 2, followed by 125 μg at Week 4, and then 125 μg SC injection every 2 weeks up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks. |
| Avonex | ACTIVE_COMPARATOR | Participants will receive Avonex (interferon beta type 1a) starting at a dose of 7.5 μg on Day 1, followed by an increase of 7.5 μg each week for 3 weeks, followed by 30 μg intramuscular (IM) injections every week up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks. |
| BIIB017 plus current FLS therapy | EXPERIMENTAL | Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician. |
| BIIB017 plus naproxen | EXPERIMENTAL | Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently. |
| Placebo | PLACEBO_COMPARATOR | Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks. |
| Peginterferon Beta-1a Q2W | EXPERIMENTAL | 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks. |
| Peginterferon Beta-1a Q4W | EXPERIMENTAL | 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm). |
| Name | Type | Description |
|---|---|---|
| BIIB017 (peginterferon beta-1a) | DRUG | Administered as specified in the treatment arm |
| Interferon beta type 1a | DRUG | Administered as specified in the treatment arm |
| BIIB017 | DRUG | - |
| naproxen | DRUG | - |
| Placebo | DRUG | Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection. |
Key Inclusion Criteria: Part 1: * Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS. * Must have an EDSS score between 0.0 and 5.5. * Must have experienced \>= 1 relapse in the 12 months prior to randomization (Day 1) or \>= 2 relapses in the 24 months p...
BIIB017 is being developed for the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis and relapsing multiple sclerosis. It is an investigational therapy studied in both adult and pediatric patients with these conditions.
BIIB017 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker symbol BIIB. Biogen is the sponsor of the clinical trials evaluating BIIB017 in multiple sclerosis.
BIIB017 is in Phase 3 clinical development. It has been evaluated in Phase 3 trials, including a completed study in adults with relapsing multiple sclerosis and an ongoing Phase 3 study in pediatric patients with relapsing-remitting multiple sclerosis.
BIIB017 has been studied in Phase 3 trials including NCT00906399, a completed efficacy and safety study in adults with relapsing multiple sclerosis, NCT01939002, a completed study of flu-like symptoms in patients transitioning from non-pegylated interferon beta therapies, and NCT03958877, an active Phase 3 trial in pediatric patients with relapsing-remitting multiple sclerosis.
Yes, BIIB017 is also known as peginterferon beta-1a or PEGylated interferon beta-1a. These names refer to the same investigational drug candidate being developed by Biogen for relapsing forms of multiple sclerosis.