Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
peginterferon beta-1a · 3 trials · 3 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
| Peginterferon Beta-1a administered to Japanese participants | EXPERIMENTAL | A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe |
| Peginterferon Beta-1a administered to Caucasian participants | EXPERIMENTAL | A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe |
| Name | Type | Description |
|---|---|---|
| peginterferon beta-1a | DRUG | Administered as specified in the treatment arm |
| Rebif | DRUG | Administered as subcutaneous injection |
Key Inclusion Criteria: * Must have completed the study treatment and visit schedule through Week 96 in Study 105MS301 (NCT00906399). Key Exclusion Criteria: * Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 (NCT00906399). * Subjects with any clinicall...
Peginterferon Beta-1a is an investigational drug being developed for the treatment of multiple sclerosis, including relapsing multiple sclerosis. It has also been studied in healthy participants for pharmacokinetic evaluations. The drug is not approved and remains in clinical development.
Peginterferon Beta-1a is developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen is conducting clinical trials to evaluate the drug's safety, efficacy, and pharmacokinetics in multiple sclerosis and healthy volunteers.
Peginterferon Beta-1a is in Phase 1 clinical development. While one completed trial was a Phase 3 study, the overall development program includes Phase 1 trials. The drug is investigational and has not been approved by regulatory authorities.
Peginterferon Beta-1a has been studied in three completed clinical trials: NCT01332019, a long-term safety and efficacy study in relapsing multiple sclerosis with 1,077 participants; NCT01978652, a pharmacokinetic study in healthy Japanese and Caucasian participants; and NCT02269930, a pharmacokinetic study comparing it to Rebif in healthy volunteers.
Peginterferon Beta-1a is not the same as Rebif, but they are related. Rebif is interferon beta-1a, while Peginterferon Beta-1a is a pegylated form of interferon beta-1a. A clinical trial (NCT02269930) directly compared the pharmacokinetic profiles of Peginterferon Beta-1a and Rebif in healthy volunteers.