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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, Plegridy, PEGylated Interferon beta-1a, PEG IFN β-1a
Peginterferon Beta-1a · 5 trials · 3 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.
AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.
Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.
Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.
Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.
Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.
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. |
| peginterferon beta-1a Q4W | EXPERIMENTAL | 125 µg peginterferon beta-1a administered by subcutaneous (SC) injection every 4 weeks (Q4W) for at least 2 years and up to 4 years. |
| peginterferon beta-1a Q2W | EXPERIMENTAL | 125 μg peginterferon beta-1a administered by SC injection every 2 weeks (Q2W) for at least 2 years and up to 4 years. |
| 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. |
| Group 1 | EXPERIMENTAL | Treatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 |
| Group 2 | EXPERIMENTAL | Treatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 |
| 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 | - |
| peginterferon beta-1a | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection. |
| Rebif | DRUG | Administered as 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...
Peginterferon Beta-1a is being studied for the treatment of multiple sclerosis, including relapsing multiple sclerosis. It is a pegylated form of interferon beta-1a developed by Biogen Inc. (ticker: BIIB). The drug is designed to provide a longer-lasting version of interferon beta-1a for patients with relapsing forms of MS.
Peginterferon Beta-1a targets the interferon alpha/beta receptor subunits IFNAR1 and IFNAR2. It acts as an agonist at these receptors, meaning it activates them. This receptor activation triggers signaling pathways that mimic the effects of naturally occurring interferon beta, which is thought to help modulate the immune system in multiple sclerosis.
Peginterferon Beta-1a is being developed by Biogen Inc., which trades under the ticker symbol BIIB. Biogen is a biotechnology company focused on neurological and neurodegenerative diseases. The company has conducted clinical trials of this drug candidate in multiple sclerosis.
Peginterferon Beta-1a has been studied in Phase 1 and Phase 3 clinical trials. The Phase 1 trial evaluated its pharmacokinetic profile, while the Phase 3 trial assessed long-term safety and efficacy in relapsing multiple sclerosis. It is an investigational drug and has not been approved by the FDA for any indication.
Peginterferon Beta-1a has been evaluated in two completed clinical trials. The Phase 1 trial, NCT02269930, compared the pharmacokinetic profiles of BIIB017 (Peginterferon Beta-1a) and Rebif (interferon beta-1a) in 30 healthy volunteers. The Phase 3 trial, NCT01332019, studied long-term safety and efficacy in 1,077 patients with relapsing multiple sclerosis across multiple countries.