A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301

Biogen1 site in 1 country1,501 target enrollmentFebruary 15, 2013

ConditionsRelapsing-Remitting Multiple Sclerosis Multiple Sclerosis

InterventionsBIIB019 (Daclizumab)

DrugsBIIB019 (Daclizumab)

Overview

Phase: Phase 3
Intervention: BIIB019 (Daclizumab)
Conditions: Relapsing-Remitting Multiple Sclerosis
Sponsor: Biogen
Enrollment: 1501
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

Secondary objectives of this study in this study population are as follows:

To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).

Detailed Description

Enrollment will include up to 1600 Participants, this includes approximately 1200 Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400 Participants from the other BIIB019 extension studies 205MS203 (NCT01051349) and 205MS302 (NCT01462318) will be eligible to enter Study 205MS303 at Week 144 of Study 205MS303 \[Study 205MS301 (NCT01064401), study 205MS203 (NCT01051349) and study 205MS302 (NCT01462318) have been referred to as parent studies in the protocol\]. All Participants will receive the same dose of DAC HYP as received in the parent studies; i.e., 150 mg by an SC injection every 4 weeks.

Registry

clinicaltrials.gov

Start Date

February 15, 2013

End Date

September 24, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later).
•Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.

Exclusion Criteria

•Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
•Any significant change in the subject's medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
•The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS
•NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Arms & Interventions

BIIB019

BIIB019 150 mg subcutaneous (SC) every 4 weeks

Intervention: BIIB019 (Daclizumab)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame: First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could 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. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Secondary Outcomes

Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period(Up to 4.6 years in the 303 study)
Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period(Up to 5.6 years combining 303 with the initial Study 301)
Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period(Baseline 301, Weeks 24, 96, 144 in Study 301)
Number of Participants With Relapse in the 205MS303 Treatment Period(Up to 4.6 years in the 303 study)
Number of Participants With Relapse in the 205MS301-303 Combined Study Period(Up to 5.6 years combining 303 with the initial Study 301)
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period(Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303)
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period(Baseline 303, Weeks 12, 24, 48, 96, 120 and 144)
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303)
ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period(Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study)
Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period(Up to 4.6 years in Study 303)
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period(Baseline 301, Weeks 24, 96, 144 in Study 301)
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period(Baseline 301, Weeks 24, 96 and 144)
Percent Change in Brain Volume From the 205MS303 Baseline(Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303)
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period(Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303)
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period(Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303)
Percent Change in Brain Volume From 205MS301 Baseline(Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303)
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period(Baseline 303, Weeks 12, 24 and 48 in Study 303)
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period(Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study)
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96)
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303)
Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period(Up to 4.6 years in Study 303)
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303)
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303)
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period(Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96)
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories(After the first and fourth injections in 303, approximately Week 0 and Week 12)
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period(Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303)
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period(Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301)
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period(Up to 4.6 years in the 303 Treatment Period)
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period(Baseline 303, Weeks 144, 168, 192, 240 in 303)
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period(Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303)
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period(Up to 4.6 years in 303)
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period(301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303)
Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS(After the first and fourth injections in 303, approximately Week 0 and Week 12)
Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period(Up to 4.6 years in the 303 Treatment Period)
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period(Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study)