EXTEND
What it found
The trial ended early for another reason (see below).
Reason given: Study terminated because of differences in the participant population under study compared with indicated Zinbryta use in most countries.
What was tested
Treatment tested
- Daclizumab
Interleukin-2 receptor inhibitor
Results by group
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 541 Participants | 597 | |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 560 Participants | 606 | |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 172 Participants | 227 | |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 53 Participants | 70 | |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 157 Participants | 597 | |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 190 Participants | 606 | |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 38 Participants | 227 | |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 15 Participants | 70 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 597 | 157 (26.3%) | 2 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 606 | 190 (31.4%) | 4 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 70 | 15 (21.4%) | 0 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 227 | 38 (16.7%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)
SafetyIncidence of AEs and SAEs
Safety
Other measures (43)
Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period
Up to 4.6 years in the 303 study
Disability progressionRelapsesARR 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
Disability progressionRelapsesNumber of Participants With Relapse in the 205MS303 Treatment Period
Up to 4.6 years in the 303 study
RelapsesNumber of Participants With Relapse in the 205MS301-303 Combined Study Period
Up to 5.6 years combining 303 with the initial Study 301
RelapsesNumber of Participants With Sustained Disability Progression in the 205MS303 Treatment Period
Up to 4.6 years in Study 303
Disability progressionNumber 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
Disability progressionNumber 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
MRI lesionsNumber of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period
Baseline 301, Weeks 24, 96, 144 in Study 301
MRI lesionsNumber 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
MRI lesionsNumber of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period
Baseline 301, Weeks 24, 96 and 144
MRI lesions
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study.J Neurol · 2020
Results
Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.
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History
Started
Feb 2013
Main results due
Sept 2018
Finished
Sept 2018
Results posted
Dec 2019
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