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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-001161-42
    Sponsor's Protocol Code Number:205-MS-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-001161-42
    A.3Full title of the trial
    Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis.
    A.3.2Name or abbreviated title of the trial where available
    SELECT
    A.4.1Sponsor's protocol code number205-MS-201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec Ltd.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number100
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeHumanised IgG1 monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple sclerosis (MS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapse between baseline and week 52
    E.2.2Secondary objectives of the trial
    To determine whether DAC HYP is effective in:
    - Reducing the number of new Gd-enhancing lesions over 5 brain MRI scans at weeks 8,12,16,20 and 24 (calculated as the sum of these 5 MRIs) in a subset of subjects
    - Reducing the number of new or newly-enlarging T2 hyperintense lesions at Week 52
    - Reducing the proportion of relapsing subjects between baseline amd week 52
    -Improving quality of life as measured by the MSIS-29 physical score at week 24 compared to baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
    2. Must be 18 to 55 years of age, inclusive, at the time of informed consent.
    3. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald
    criteria #1-4 (Polman et al, 2005; Section 22).
    4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
    5. Must meet either of the following 2 criteria:
    • Have experienced at least 1 relapse within the 12 months prior to randomization,
    with a cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to
    obtain a current scan if a scan performed previously is available from the subject’s
    history; if a scan is not available from the subject’s history, then the baseline scan
    may be used). For inclusion purposes, a relapse is defined as neurologic signs and/or
    symptoms documented by a neurologist in the medical record and of at least 24 Time since relapse should be measured from the time of relapse onset, OR
    • Show evidence of Gd-enhancing lesions of the brain on an MRI performed within
    the 6 weeks prior to randomization (if scan is not available from the subject’s
    history, then baseline scan may be used).
    6. Must be disqualified from standard treatment for MS (sites in Poland only). Candidates in Poland must be from one of the following patient populations:
    • Patients who rejected standard treatment for MS,
    • Patients with contraindications for using standard treatment for MS,
    • Patients for whom standard treatment for MS has proven ineffective,
    • Patients who are on the waiting list for state-funded standard treatment for MS, but who will not receive standard treatment for the duration of the study (15 months).
    7. Male subjects and female subjects of child-bearing potential must be willing to 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. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 2001 [Section 23]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement.
    2. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study.
    3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
    4. History of abnormal laboratory results that, in the opinion of the investigator, are
    indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic,
    psychiatric, renal, neurologic (other than MS), and/or other major disease that would
    preclude administration of DAC HYP.
    5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.
    6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
    7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
    8. Positive for hepatitis C virus (HCV) antibody and/or positive for hepatitis B surface
    antigen (HBsAg) at Screening.
    9. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening.
    10. Exposure to varicella zoster virus within 21 days before Screening.
    11. Any of the following abnormal blood tests at Screening:
    • Hemoglobin ≤9.0 g/dL
    • Platelets ≤100 × 10^9/L
    • Lymphocytes ≤1.0 × 10^9/L
    • Neutrophils ≤1.5 × 10^9 /L
    • Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT),
    aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT),
    or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN)
    • Serum creatinine >ULN.
    Treatment History
    12. Any previous treatment with DAC HYP or Zenapax®.
    13. Any of the following types of live virus vaccine from 4 weeks before randomization:
    measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and
    nasal influenza vaccine. Use of these vaccines, however, by other members of the
    subject’s household does not affect the eligibility of subjects to enroll or continue in the study.
    14. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV)
    antibiotics within 8 weeks before randomization.
    15. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study.
    16. Prior treatment with any of the following:
    • total lymphoid irradiation
    • cladribine
    • mitoxantrone
    • T-cell or T-cell receptor vaccination
    • any therapeutic monoclonal antibody, except natalizumab or rituximab.
    17. Prior treatment with cyclophosphamide or rituximab within 1 year prior to
    randomization.
    18. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:
    • natalizumab
    • cyclosporine
    • azathioprine
    • methotrexate
    • intravenous immunoglobulin (IVIg)
    • plasmapheresis or cytapheresis.
    19. Prior treatment with any of the following within the 3 months prior to randomization:
    • SC or oral glatiramer acetate
    • IFN-alpha
    • IFN-beta (subjects who are positive for neutralizing antibodies to IFN-beta may
    receive IFN-beta treatment up to 2 weeks prior to randomization).
    20. Treatment with any of the following medications within the 30 days prior to
    randomization:
    • IV corticosteroid treatment
    • oral corticosteroid treatment
    • 4-aminopyridine or related products.
    Miscellaneous
    21. Female subjects considering becoming pregnant while in the study.
    22. Female subjects who are currently pregnant or breastfeeding.
    23. Previous participation in this study.
    24. Subjects for whom MRI is contraindicated, i.e., have pacemakers or other
    contraindicated implanted metal devices, are allergic to gadolinium, or have
    claustrophobia that cannot be medically managed.
    25. Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to randomization.
    26. 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.
    27. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the annualised relapse rate between baseline and week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of the trial is defined as last subject, last visit.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.3Elderly (>=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 Information not present in EudraCT
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 457
    F.4.2.2In the whole clinical trial 600
    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 Decision2008-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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