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    Summary
    EudraCT Number:2012-003176-39
    Sponsor's Protocol Code Number:205MS303
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-22
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-003176-39
    A.3Full title of the trial
    A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301
    A.3.2Name or abbreviated title of the trial where available
    EXTEND
    A.4.1Sponsor's protocol code number205MS303
    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 Idec Research Limited
    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 Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointEXTEND Clinical Trials Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL64AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailneurologyclinicaltrials@biogenidec.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 16.0
    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
    The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are as follows:
    • To assess the long-term immunogenicity of DAC HYP administered by PFS
    • To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP
    • To assess the safety, tolerability, and efficacy of switching to DAC HYP in subjects previously on long-term treatment with interferon β 1a in Study 205MS301
    • To evaluate PD parameters that may be associated with treatment response
    E.2.3Trial contains a sub-study No
    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 protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96).
    Note: Subjects who are not able to enroll into 205MS303 at the time of their Week 144/End of Study Visit may be eligible to enroll into 205MS303 at a later time if they are still participating in the 6-month follow-up period of 205MS301 at the time of expected rollover into 205MS303.
    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.
    E.4Principal exclusion criteria
    Medical History
    1. Any subject who permanently discontinued study treatment in Study 205MS301 prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301.
    Note: Subjects for whom dosing was temporarily suspended in Study 205MS301 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the Study 205MS301 protocol have been met at the time of enrollment into Study 205MS303.
    2. Any significant change in the subject’s medical history 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 Study 205MS301. The Investigator must re review the subject’s medical fitness for participation and consider any factors that would preclude treatment in Study 205MS303, including:
    • History of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease (e.g., malignancy) that would preclude administration of DAC HYP.
    • Clinically significant laboratory abnormalities (hematology and blood chemistry) from the most recently available test in Study 205MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in Protocol 205MS301 are exclusionary.
    3. Any of the following abnormal blood tests within the 7 days prior to Day 1:
    • alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) >3 the upper limit of normal (ULN)
    Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until ALT/SGPT and AST/SGOT are 2 ULN.
    • total bilirubin >2 ULN (subjects with an established diagnosis of Gilbert's syndrome are excluded if total bilirubin is >2.5 ULN)
    Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until total bilirubin 1 ULN (subjects with an established diagnosis of Gilbert's syndrome may not enroll into 205MS303 until total bilirubin is 1.5 ULN).
    4. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
    Treatment History
    5. Treatment with any prohibited concomitant medication during Study 205MS301.
    Note: Subjects who start an approved, open-label IFN β preparation after completion of dosing in Study 205MS301 are not excluded, but IFN β treatment must be discontinued before the first dose of DAC HYP in Study 205MS303 is given.
    Miscellaneous
    6. Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study.
    7. Previous participation in Study 205MS303.
    8. History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS301.
    9. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Primary End Points include incidence of AEs including serious AEs (SAEs), discontinuation of DAC HYP due to AEs, and withdrawals due to AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    As necessary
    E.5.2Secondary end point(s)
    • Shifts in clinical laboratory assessments (hematology and blood chemistry)
    • Incidence of depression as assessed by the Beck Depression Inventory, Second Edition (BDI-II)
    • Incidence of anti-DAC binding antibodies (ADAbs) over time
    • Incidence of anti-DAC HYP neutralizing antibodies (NAbs) over time
    • Relapse outcomes: annualized relapse rate (ARR), and proportion of subjects who relapse
    • Sustained disability progression defined by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) score 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
    • Magnetic Resonance Imaging (MRI) outcomes: total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI (Note: The decision to collect and analyze brain atrophy data will be made after the analysis of Study 205MS301 is complete. Brain atrophy analysis may be omitted.)
    • Change in Multiple Sclerosis Functional Composite (MSFC) score
    • Change in EDSS score
    • Proportion of subjects who are free from disease activity.
    • Proportion of subjects with sustained improvement in disability as defined by the number of subjects with baseline EDSS of at least 2.0 who experience ≥1.0 decrease in EDSS that is sustained for 24 weeks.
    • Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical and psychological scores
    • Change in quality of life as assessed by the European Quality of Life, 5 dimensions (EQ-5D and EQ VAS)
    • Change in direct HRU (hospitalizations, emergency room visits, and unscheduled neurologist visits)
    • Change in treatment satisfaction as assessed by the subject
    • Change in subject productivity as assessed by the HRPQ
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the course of the study
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 EEA120
    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
    Argentina
    Australia
    Brazil
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Georgia
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Mexico
    Moldova, Republic of
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Sweden
    Switzerland
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1841
    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 Information not present in EudraCT
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 889
    F.4.2.2In the whole clinical trial 1841
    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)
    As per protocol
    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 Decision2013-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-24
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