Stopped earlyPhase 3Relapsing MSNCT017979652012-003176-39

What it found

Stopped early

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

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)

GroupValueIntervalNumber analysed
IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)541 Participants597
DAC HYP 150 mg (301) /DAC HYP 150 mg (303)560 Participants606
DAC HYP 150 mg (203) /DAC HYP 150 mg (303)172 Participants227
DAC HYP 150 mg (302) /DAC HYP 150 mg (303)53 Participants70
IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)157 Participants597
DAC HYP 150 mg (301) /DAC HYP 150 mg (303)190 Participants606
DAC HYP 150 mg (203) /DAC HYP 150 mg (303)38 Participants227
DAC HYP 150 mg (302) /DAC HYP 150 mg (303)15 Participants70

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
IFN β-1a 30 µg (301)/DAC HYP 150 mg (303)597157 (26.3%)2
DAC HYP 150 mg (301) /DAC HYP 150 mg (303)606190 (31.4%)4
DAC HYP 150 mg (302) /DAC HYP 150 mg (303)7015 (21.4%)0
DAC HYP 150 mg (203) /DAC HYP 150 mg (303)22738 (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)

    Safety
  • Incidence 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 progressionRelapses
  • 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

    Disability progressionRelapses
  • Number of Participants With Relapse in the 205MS303 Treatment Period

    Up to 4.6 years in the 303 study

    Relapses
  • Number of Participants With Relapse in the 205MS301-303 Combined Study Period

    Up to 5.6 years combining 303 with the initial Study 301

    Relapses
  • Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period

    Up to 4.6 years in Study 303

    Disability progression
  • 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

    Disability progression
  • 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

    MRI lesions
  • 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

    MRI lesions
  • 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

    MRI lesions
  • Number 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

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Linked trials

  • Extension of

    SELECTED

    Phase 2 · Completed

  • Extension of

    (DECIDE)

    Phase 3 · Completed

  • Extension of

    OBSERVE

    Phase 3 · Completed

Links found where a registry record names another trial's registry number.

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History

    1. Started

      Feb 2013

    2. Main results due

      Sept 2018

    3. Finished

      Sept 2018

    4. Results posted

      Dec 2019

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