Recent Updates
Recently added Catalysts

peginterferon beta-1a

Phase 3

Relapsing Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Jan 13, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,077
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01332019Long-Term Safety and Efficacy Study of Peginterferon Beta-1aPHASE3 COMPLETED 1,077Apr 1, 2011Oct 1, 2015Jan 13, 2017151 United States, Belgium +24
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs
up to 4 years

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.

Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
up to 4 years

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.

Number of Participants With Shifts From Baseline: Liver Function Laboratory Values
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

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.

Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

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.

Number of Participants With Shifts From Baseline: Urinalysis
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

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.

Secondary Endpoints
Annualized Relapse Rate (ARR)
up to 4 years
Percentage of Participants Who Relapsed
Up to 4 years
Number of New or Newly Enlarging T2 Hyperintense Lesions
Week 48, Week 96
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
peginterferon beta-1a Q4WEXPERIMENTAL125 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 Q2WEXPERIMENTAL125 μg peginterferon beta-1a administered by SC injection every 2 weeks (Q2W) for at least 2 years and up to 4 years.
Interventions
NameTypeDescription
peginterferon beta-1aDRUGAdministered as specified in the treatment arm
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites151

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...

Countries:United StatesBelgiumBulgariaCanadaChileColombiaCroatiaCzechiaEstoniaFranceGeorgiaGermanyGreeceIndiaLatviaMexicoNetherlandsNew ZealandPeruPolandRomaniaRussiaSerbiaSpainUkraineUnited Kingdom
Unlock Eligibility Criteria