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    Summary
    EudraCT Number:2009-015318-23
    Sponsor's Protocol Code Number:205MS203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2009-015318-23
    A.3Full title of the trial
    A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION)
    A.3.2Name or abbreviated title of the trial where available
    SELECTED
    A.4.1Sponsor's protocol code number205MS203
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiogen
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House; 70 Norden Road
    B.5.3.2Town/ cityMaidenhead; Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailselectstudy@biogen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDACLIZUMAB HYP
    D.3.2Product code BIIB019
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaclizumab
    D.3.9.2Current sponsor codeBIIB019
    D.3.9.3Other descriptive nameDaclizumab HYP (DAC HYP)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-remitting Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS.
    E.2.2Secondary objectives of the trial
    To assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    2013-2014 Influenza Vaccine Substudy

    The objective of the optional administration of the of the 2013-2014 trivalent seasonal influenza vaccine is to assess the effect of DAC HYP treatment on the immune response to licensed trivalent seasonal influenza vaccine, as defined by HI titer.
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.
    2. Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator.
    3. 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.

    Inclusion criteria for the 2013-2014 Influenza Vaccine Substudy:
    1. Subjects must provide specific informed consent for the 2013-2014 Influenza Vaccine Substudy
    2. Subjects must have completed at least 3 months of uninterrupted therapy with DAC HYP prior to entering the 2013-2014 Influenza Vaccine Substudy
    E.4Principal exclusion criteria
    1. Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, 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 or 205MS202 studies. The Investigator must re review the subject’s medical fitness for participation and must consider any diseases that would preclude treatment.
    2. Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE.
    3. Current enrollment in any investigational drug study other than 205MS202.
    4. Ongoing treatment with any approved or experimental disease-modifying treatment for MS.
    5.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 may use an alternative medication allowed by the protocol as needed.
    Note: Subjects who have been taking 1 of these medications at a stable dose for at least 6 consecutive months prior to study entry may continue to receive the medication without alteration and are eligible for study participation.
    6. 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 prior to initiation of study treatment in this study.
    7. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.

    Exclusion Criteria for the 2013-2014 Influenza Vaccine Substudy:
    1. Subject has had a severe allergic reaction (e.g., anaphylaxis) to eggs, egg proteins (a vaccine component), or any other component of the trivalent seasonal influenza vaccine.
    2. Subject has had a serious reaction to previous influenza vaccination.
    3. Subject has a known latex allergy.
    4. Subject was previously vaccinated for the 2013-2014 influenza season strain.
    5. Subject had a respiratory illness in the 2 weeks preceding the planned vaccination with the 2013-2014 trivalent seasonal influenza vaccine.
    6. Subject has any ongoing adverse event or laboratory abnormality in SELECTED that has resulted in suspension of DAC HYP treatment at the time of enrollment into the 2013-2014 Influenza Vaccine Substudy.
    7. Subject has received in the last 3 months: blood products oral or intravenous corticosteroids intravenous immunoglobulins
    8. Subject has received any vaccination in the last 4 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the study are AEs, including SAEs, discontinuation of DAC HYP due to AEs, and withdrawals due to AEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical Adverse Events:
    All treatment-emergent events during 205MS203 will be included in the evaluation of safety. Treatment emergent includes any event that either occurs or worsens in severity after the onset of study treatment in 205MS203.
    Clinical Adverse Events over Time:
    In order to assess whether the incidence of events changes over time, the incidence will also be summarized by time period.
    E.5.2Secondary end point(s)
    • Immunogenicity
    • Sustained disability progression defined by at least a 1.0-point increase on the EDSS
    from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase
    on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks
    • Annual change in total number and volume of new or newly enlarging T2 hyperintense
    lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI
    • Annualized Relapse Rate (ARR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity -at baseline, every 12 weeks through week 48, at week 96, at week 144, at week 192, at week 240, at week 288, at final study visit, at relapse assessment if applicable, and at early termination visit if applicable.
    EDSS- at baseline, every 24 weeks, and at early termination visit if applicable
    MRI - at baseline, week 48, 96, 192, 240, and 288.
    ARR- annually
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    India
    Russian Federation
    Ukraine
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    As stated in the Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 450
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No further provisions are made for access to the study treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-30
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