CompletedPhase 2Relapsing MSNCT010513492009-015318-23

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Daclizumab

    Interleukin-2 receptor inhibitor

  • trivalent seasonal influenza vaccine

Results by group

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs

Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)

GroupValueIntervalNumber analysed
BIIB019358 Participants410
BIIB019148 Participants410
BIIB01991 Participants410
BIIB01990 Participants410

BIIB019

358

BIIB019

148

BIIB019

91

BIIB019

90

Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab

Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

GroupValueIntervalNumber analysed
BIIB019 (Prefilled Syringe [PFS])610.5 hr*mg/mL253.89 (Standard Deviation)30
BIIB019 (Autoinjector [AI])666.8 hr*mg/mL253.19 (Standard Deviation)30

BIIB019 (Prefilled Syringe [PFS])

610.5

BIIB019 (Autoinjector [AI])

666.8

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
BIIB019410148 (36.1%)

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), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs

    Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)

    Safety
  • Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab

    Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

  • The primary endpoints of the study are AEs, including SAEs,

    Safety

Other measures (17)

  • Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

    From Baseline through 288 weeks

    MRI lesions
  • Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

    From Baseline through 288 weeks

    MRI lesions
  • Number of Participants With Total Number of New Gadolinium-enhancing Lesions

    From Baseline through 288 weeks

    MRI lesions
  • Annual Change in Number of T1 Hypointense Lesions

    From Baseline through 288 weeks

    MRI lesions
  • Annual Change in Volume of New Gadolinium-Enhancing Lesions

    From Baseline through 288 weeks

    MRI lesions
  • Annual Change in Volume of T1 Hypointense Lesions

    From Baseline through 288 weeks

    MRI lesions
  • Percent Change in Total Brain Volume

    From Baseline through 288 weeks

    MRI lesionsBrain volume loss
  • Number of Participants With Antibodies to DAC HYP

    Up to Week 288

  • Annualized Relapse Rate (ARR)

    Week 288

    Relapses
  • Number of Participants With Sustained Disability Progression for 12 Weeks

    Week 48 up to Week 288

    Disability progression

Who could take part

Relapsing MS · 18 to 60

Main Study Eligibility: Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. * Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator. * 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: * Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740) studies. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment. * Any subject who has permanently discontinued study treatment in Study 205MS202 (NCT00870740) due to an adverse event. * Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740). * Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis. * For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin: * Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry. * Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry. * Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry * Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol. 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

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.

Papers

Loading reviews and guidelines…

Linked trials

  • Extended by

    EXTEND

    Phase 3 · Stopped early

  • Extension of

    SELECT

    Phase 2 · Completed

  • Extension of

    SELECTION

    Phase 2 · Completed

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

Related trials

History

    1. Started

      Mar 2010

    2. Main results due

      Aug 2016

    3. Finished

      Aug 2016

    4. Results posted

      Nov 2018

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