Overview

This trial is active, not recruiting.

Conditions relapsing-remitting multiple sclerosis, multiple sclerosis
Treatment biib019 (daclizumab)
Phase phase 3
Sponsor Biogen
Collaborator AbbVie
Start date February 2013
End date August 2019
Trial size 1501 participants
Trial identifier NCT01797965, 2012-003176-39, 205MS303

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BIIB019 150 mg subcutaneous (SC) every 4 weeks
biib019 (daclizumab) Daclizumab High Yield Process
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.

Primary Outcomes

Measure
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial Study 205MS301 (NCT01064401),Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318)

Secondary Outcomes

Measure
Annualized Relapse Rate (ARR)
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302
Number of participants who relapse
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302
Number of participants with sustained disability progression
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302
Total number of new or newly enlarging T2 hyperintense lesions, gadolinium-enhancing (Gd+) lesions, T1 hypointense lesions, and brain volume change on brain MRI
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302
Volume of new or newly enlarging T2 hyperintense lesions, gadolinium-enhancing (Gd+) lesions and T1 hypointense lesions
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302
Change from baseline in Expanded Disability Status Scale (EDSS) score
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302
Number of participants who are free from disease activity
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302
Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS29) physical and psychological scores
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302
Change in quality of life as assessed by the European Quality of Life, 5 dimensions (EQ 5D and EQ VAS)
time frame: Up to 5 years during the Open-Label Extension Study 205MS303
Change from baseline in direct health resource utilization (HRU)
time frame: Up to 5 years during the Open-Label Extension Study 205MS303
Change from baseline in treatment satisfaction as assessed by the participants
time frame: Up to 5 years during the Open-Label Extension Study 205MS303
Change from baseline in participant productivity as assessed by the Health Related Productivity Questionnaire (HRPQ)
time frame: Up to 5 years during the Open-Label Extension Study 205MS303
Change from baseline in participants with clinically notable laboratory abnormalities
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302
Local tolerability as assessed by subject-reported injection site pain (visual analog scale [VAS]) and clinician injection site assessments
time frame: Up to 5 years during the Open-Label Extension Study 205MS303
Number of participants with anti-BIIB019 binding antibodies (ADAbs) over time
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302
Number of participants with anti-BIIB019 neutralizing antibodies (NAbs) over time
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302
Change from baseline in Symbol Digit Modalities Test (SDMT) score
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301
Change from baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) score
time frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301

Eligibility Criteria

Male or female participants at least 18 years old.

Key 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. Key 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 205MS303. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title 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
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. The duration of DAC HYP treatment is up to approximately 5 years, or until availability of commercial product (whichever is sooner).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biogen.