MSFrontier

SELECTION

A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
CompletedPhase 2Relapsing MSNCT008707402008-005559-46

What it found

Main goal was not benefit

The main measure was safety, drug levels or similar, not whether the treatment works.

“The primary endpoints were the safety and immunogenicity of daclizumab HYP.”
Read by software from the paper's abstract

52 weeks

GroupnValue
Treatment initiation group17011 patients (6%) had any serious adverse event other than relapse; 4 (2%) positive for neutralising antidrug antibodies
Continuous treatment group17313 patients (8%) had any serious adverse event other than relapse; 1 (1%) of 128 positive for neutralising antidrug antibodies

Total participants: 517

Read by software from the paper's abstract

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Number of Participants With Treatment-emergent Adverse Events (AEs)

Up to 72 weeks

GroupValueIntervalNumber analysed
Placebo + DAC HYP 150 mg61 participants86
Placebo + DAC HYP 300 mg57 participants84
DAC HYP 150 mg + Washout70 participants86
DAC HYP 150 mg for 2 Years57 participants86
DAC HYP 300 mg + Washout61 participants88
DAC HYP 300 mg for 2 Years62 participants87
Placebo + DAC HYP 150 mg37 participants86
Placebo + DAC HYP 300 mg33 participants84
DAC HYP 150 mg + Washout45 participants86
DAC HYP 150 mg for 2 Years41 participants86
DAC HYP 300 mg + Washout35 participants88
DAC HYP 300 mg for 2 Years35 participants87
Placebo + DAC HYP 150 mg1 participants86
Placebo + DAC HYP 300 mg3 participants84
DAC HYP 150 mg + Washout3 participants86
DAC HYP 150 mg for 2 Years2 participants86
DAC HYP 300 mg + Washout4 participants88
DAC HYP 300 mg for 2 Years4 participants87
Placebo + DAC HYP 150 mg18 participants86
Placebo + DAC HYP 300 mg12 participants84
DAC HYP 150 mg + Washout24 participants86
DAC HYP 150 mg for 2 Years13 participants86
DAC HYP 300 mg + Washout22 participants88
DAC HYP 300 mg for 2 Years22 participants87
Placebo + DAC HYP 150 mg15 participants86
Placebo + DAC HYP 300 mg11 participants84
DAC HYP 150 mg + Washout18 participants86
DAC HYP 150 mg for 2 Years15 participants86
DAC HYP 300 mg + Washout15 participants88
DAC HYP 300 mg for 2 Years11 participants87

Number of Participants With Abnormalities in Vital Signs

Up to Week 72

GroupValueIntervalNumber analysed
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg1 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg1 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout1 participants86
DAC HYP 150 mg for 2 Years1 participants86
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87

Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities

Up to 72 Weeks

GroupValueIntervalNumber analysed
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg3 participants84
DAC HYP 150 mg + Washout3 participants85
DAC HYP 150 mg for 2 Years4 participants85
DAC HYP 300 mg + Washout3 participants88
DAC HYP 300 mg for 2 Years2 participants87
Placebo + DAC HYP 150 mg4 participants85
Placebo + DAC HYP 300 mg2 participants84
DAC HYP 150 mg + Washout1 participants85
DAC HYP 150 mg for 2 Years1 participants85
DAC HYP 300 mg + Washout3 participants88
DAC HYP 300 mg for 2 Years1 participants87
Placebo + DAC HYP 150 mg5 participants85
Placebo + DAC HYP 300 mg4 participants84
DAC HYP 150 mg + Washout6 participants85
DAC HYP 150 mg for 2 Years3 participants85
DAC HYP 300 mg + Washout2 participants88
DAC HYP 300 mg for 2 Years5 participants87
Placebo + DAC HYP 150 mg1 participants85
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout1 participants85
DAC HYP 150 mg for 2 Years1 participants85
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants85
DAC HYP 150 mg for 2 Years0 participants85
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout1 participants85
DAC HYP 150 mg for 2 Years0 participants85
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years1 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg4 participants84
DAC HYP 150 mg + Washout2 participants85
DAC HYP 150 mg for 2 Years2 participants85
DAC HYP 300 mg + Washout5 participants88
DAC HYP 300 mg for 2 Years2 participants87
Placebo + DAC HYP 150 mg4 participants85
Placebo + DAC HYP 300 mg3 participants84
DAC HYP 150 mg + Washout2 participants85
DAC HYP 150 mg for 2 Years1 participants85
DAC HYP 300 mg + Washout4 participants88
DAC HYP 300 mg for 2 Years2 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants85
DAC HYP 150 mg for 2 Years0 participants85
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants85
DAC HYP 150 mg for 2 Years0 participants85
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg1 participants85
Placebo + DAC HYP 300 mg5 participants84
DAC HYP 150 mg + Washout3 participants85
DAC HYP 150 mg for 2 Years3 participants85
DAC HYP 300 mg + Washout3 participants88
DAC HYP 300 mg for 2 Years3 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants85
DAC HYP 150 mg for 2 Years0 participants85
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years1 participants87
Placebo + DAC HYP 150 mg0 participants85
Placebo + DAC HYP 300 mg2 participants84
DAC HYP 150 mg + Washout1 participants85
DAC HYP 150 mg for 2 Years0 participants85
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87

Number of Participants With Abnormalities in Blood Chemistry Laboratory Data

Up to 72 Weeks

GroupValueIntervalNumber analysed
Placebo + DAC HYP 150 mg65 participants86
Placebo + DAC HYP 300 mg62 participants84
DAC HYP 150 mg + Washout61 participants86
DAC HYP 150 mg for 2 Years62 participants86
DAC HYP 300 mg + Washout60 participants88
DAC HYP 300 mg for 2 Years55 participants87
Placebo + DAC HYP 150 mg18 participants86
Placebo + DAC HYP 300 mg17 participants84
DAC HYP 150 mg + Washout16 participants86
DAC HYP 150 mg for 2 Years19 participants86
DAC HYP 300 mg + Washout20 participants88
DAC HYP 300 mg for 2 Years20 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years3 participants87
Placebo + DAC HYP 150 mg1 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout1 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout2 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years1 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg72 participants86
Placebo + DAC HYP 300 mg66 participants84
DAC HYP 150 mg + Washout71 participants86
DAC HYP 150 mg for 2 Years63 participants86
DAC HYP 300 mg + Washout68 participants88
DAC HYP 300 mg for 2 Years62 participants87
Placebo + DAC HYP 150 mg13 participants86
Placebo + DAC HYP 300 mg14 participants84
DAC HYP 150 mg + Washout9 participants86
DAC HYP 150 mg for 2 Years20 participants86
DAC HYP 300 mg + Washout14 participants88
DAC HYP 300 mg for 2 Years18 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout1 participants86
DAC HYP 150 mg for 2 Years1 participants86
DAC HYP 300 mg + Washout2 participants88
DAC HYP 300 mg for 2 Years2 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years2 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg76 participants86
Placebo + DAC HYP 300 mg83 participants84
DAC HYP 150 mg + Washout80 participants86
DAC HYP 150 mg for 2 Years80 participants86
DAC HYP 300 mg + Washout81 participants88
DAC HYP 300 mg for 2 Years82 participants87
Placebo + DAC HYP 150 mg8 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout4 participants86
DAC HYP 150 mg for 2 Years4 participants86
DAC HYP 300 mg + Washout5 participants88
DAC HYP 300 mg for 2 Years4 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg74 participants86
Placebo + DAC HYP 300 mg71 participants84
DAC HYP 150 mg + Washout74 participants86
DAC HYP 150 mg for 2 Years74 participants86
DAC HYP 300 mg + Washout73 participants88
DAC HYP 300 mg for 2 Years73 participants87
Placebo + DAC HYP 150 mg5 participants86
Placebo + DAC HYP 300 mg8 participants84
DAC HYP 150 mg + Washout5 participants86
DAC HYP 150 mg for 2 Years6 participants86
DAC HYP 300 mg + Washout8 participants88
DAC HYP 300 mg for 2 Years9 participants87
Placebo + DAC HYP 150 mg2 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout2 participants86
DAC HYP 150 mg for 2 Years2 participants86
DAC HYP 300 mg + Washout2 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg74 participants86
Placebo + DAC HYP 300 mg73 participants84
DAC HYP 150 mg + Washout81 participants86
DAC HYP 150 mg for 2 Years76 participants86
DAC HYP 300 mg + Washout78 participants88
DAC HYP 300 mg for 2 Years75 participants87
Placebo + DAC HYP 150 mg5 participants86
Placebo + DAC HYP 300 mg6 participants84
DAC HYP 150 mg + Washout2 participants86
DAC HYP 150 mg for 2 Years4 participants86
DAC HYP 300 mg + Washout4 participants88
DAC HYP 300 mg for 2 Years5 participants87
Placebo + DAC HYP 150 mg2 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years1 participants86
DAC HYP 300 mg + Washout2 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout0 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg0 participants86
Placebo + DAC HYP 300 mg0 participants84
DAC HYP 150 mg + Washout0 participants86
DAC HYP 150 mg for 2 Years0 participants86
DAC HYP 300 mg + Washout1 participants88
DAC HYP 300 mg for 2 Years0 participants87
Placebo + DAC HYP 150 mg2 participants86
Placebo + DAC HYP 300 mg1 participants84
DAC HYP 150 mg + Washout2 participants86
DAC HYP 150 mg for 2 Years2 participants86
DAC HYP 300 mg + Washout2 participants88
DAC HYP 300 mg for 2 Years2 participants87
Placebo + DAC HYP 150 mg4 participants86
Placebo + DAC HYP 300 mg4 participants84
DAC HYP 150 mg + Washout5 participants86
DAC HYP 150 mg for 2 Years4 participants86
DAC HYP 300 mg + Washout4 participants88
DAC HYP 300 mg for 2 Years3 participants87
Placebo + DAC HYP 150 mg3 participants86
Placebo + DAC HYP 300 mg10 participants84
DAC HYP 150 mg + Washout6 participants86
DAC HYP 150 mg for 2 Years4 participants86
DAC HYP 300 mg + Washout9 participants88
DAC HYP 300 mg for 2 Years9 participants87

Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline

Up to 72 weeks

GroupValueIntervalNumber analysed
Placebo + DAC HYP7 participants169
DAC HYP + Washout21 participants171
DAC HYP for 2 Years3 participants170
Placebo + DAC HYP162 participants169
DAC HYP + Washout150 participants171
DAC HYP for 2 Years167 participants170
Placebo + DAC HYP4 participants169
DAC HYP + Washout4 participants171
DAC HYP for 2 Years1 participants170
Placebo + DAC HYP165 participants169
DAC HYP + Washout167 participants171
DAC HYP for 2 Years169 participants170

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo + DAC HYP 150 mg8615 (17.4%)
Placebo + DAC HYP 300 mg8411 (13.1%)
DAC HYP 150 mg + Washout8618 (20.9%)
DAC HYP 150 mg for 2 Years8615 (17.4%)
DAC HYP 300 mg + Washout8814 (15.9%)
DAC HYP 300 mg for 2 Years8711 (12.6%)

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 Treatment-emergent Adverse Events (AEs)

    Up to 72 weeks

    Safety

  • Number of Participants With Abnormalities in Vital Signs

    Up to Week 72

    Safety

  • Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities

    Up to 72 Weeks

    Immune responseSafety

  • Number of Participants With Abnormalities in Blood Chemistry Laboratory Data

    Up to 72 Weeks

  • Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline

    Up to 72 weeks

    Immune response

  • The primary end points of the study are safety as defined by the incidence of adverse events, change in laboratory evaluations, vital signs, physical examinations and immunogenicity as defined by the development of antibodies to DAC HYP.

    Immune responseSafety

Other measures (9)

  • Adjusted Annualized Relapse Rate

    Up to 72 weeks

    Relapses

  • Estimated Proportion of Participants With a Relapse

    Up to 72 weeks

    Relapses

  • Mean Number of New Gadolinium-enhancing Lesions

    Week 20, Week 52

    MRI lesions

  • Mean Number of New or Newly-enlarging T2 Hyperintense Lesions

    Baseline, Week 20, Week 52

    MRI lesions

  • Mean Volume of New T1 Hypointense Lesions

    Baseline, Week 20, Week 52

    MRI lesions

  • Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions

    Baseline, Week 52

    MRI lesions

  • Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions

    Baseline, Week 52

    MRI lesions

  • Rate of Percentage Change From Baseline in Mean Total Brain Volume

    Baseline, Week 52

    MRI lesionsBrain volume loss

  • The secondary endpoint is to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

    RelapsesMRI lesions

Who could take part

Relapsing MS · 18 to 55

Key Inclusion Criteria: * Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator. Key Exclusion Criteria: * Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator * Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo * Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta 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 was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components: * An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201. * An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. * An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period. * An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201. The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

Papers

Loading reviews and guidelines…

Linked trials

  • Extended by

    SELECTED

    Phase 2 · Completed

  • Extension of

    SELECT

    Phase 2 · Completed

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

Related trials

History

    1. Started

      Feb 2009

    2. Main results due

      May 2012

    3. Finished

      Oct 2012

    4. Results posted

      Aug 2016

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error