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    Summary
    EudraCT Number:2010-023856-97
    Sponsor's Protocol Code Number:205MS302
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-023856-97
    A.3Full title of the trial
    A Multicenter, Single-Arm, Open-Label, Study to Evaluate
    the Immunogenicity and Pharmacokinetics of BIIB019,
    Daclizumab High Yield Process (DAC HYP), Prefilled
    Syringe Administered by Subcutaneous Injection in
    Subjects With Relapsing-Remitting Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe
    A.3.2Name or abbreviated title of the trial where available
    OBSERVE
    A.4.1Sponsor's protocol code number205MS302
    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 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 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
    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-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 INN-
    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 16.1
    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
    immunogenicity of DAC HYP 150 mg administered every
    4 weeks by an SC injection using the pre-filled syringe (PFS) in subjects with RRMS.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are
    - to characterize the PK of DAC HYP (using intensive PK data ) following single and multiple doses of DAC HYP administered by the PFS in a subset of subjects with RRMS.
    - to evaluate the effect of DAC HYP on the PK of probe drugs for CYP isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Intensive PK Sub-Study

    The following daclizumab PK parameters will be
    determined for subjects in the Intensive PK Sub-Study,
    following DAC HYP administration at Day 1 (Week 0)
    and at Week 20:
    o maximum concentration (Cmax)
    o time to reach maximum concentration (Tmax)
    o area-under-the-curve from start to end of the
    dosing interval (AUCτ)
    o trough concentrations (Ctrough)
    o apparent volume of distribution (V/F)
    o elimination half-life (t½)
    o apparent clearance (CL/F)
    Additional PK parameters may be calculated as
    appropriate during data analysis

    TP-DI Sub-Study
    • The following PK parameters for individual probe drugs will be determined for subjects in the TP-DI Sub Study:
    Primary:
    o area-under-the-curve from zero to infinity (AUC0–∞). If the
    extrapolated AUC >20%, AUC0-t where t is the time of last point with quantifiable data (tlast) may be considered if appropriate.
    o dextromethorphan to dextrorphan urine concentration ratio
    Secondary:
    o Cmax
    o CL/F
    o omeprazole/hydroxyomeprazole concentration ratio at 2 hours postomeprazole dosing
    Additional PK parameters may be calculated as appropriate during data analysis.
    E.3Principal inclusion criteria
    Main 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. Aged 18 to 65 years old, inclusive, at the time of informed consent.
    3. Must have a confirmed diagnosis of RRMS according to McDonald criteria, and a previous cranial MRI demonstrating lesion(s) consistent with MS.
    4. Must have a baseline EDSS between 0.0 and 5.0.
    5. Must have had 1 or more clinical relapses within the previous 2 years.
    Inclusion Criteria for 3-Year Treatment Extension
    1. Must have been compliant with the 205MS302 protocol during the initial 24-week treatment period and the 20-week washout period.
    2. Must resume DAC HYP treatment ≤12 weeks after completion of the washout period
    Inclusion Criteria for the TP-DI Sub-Study
    1. Compliance with the 205MS302 protocol during the initial 24-week treatment period and through Week 40 of the 20-week washout period.
    2. Must agree to resume DAC HYP treatment ≤12 weeks after
    completion of the washout period
    3. Must have normal LFT results (total bilirubin ≤1.5 × ULN, ALT/AST ≤ 2 × ULN, and prothrombin time/partial thromboplastin time ≤1.2 ×
    ULN).
    4. Must have estimated creatinine clearance >60 mL/min.
    E.4Principal exclusion criteria
    Exclusion Criteria
    1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
    2. History of malignancy.
    3. History of severe allergic or anaphylactic reactions.
    4. History of abnormal laboratory results that is indicative of any significant major disease that would preclude administration of DAC
    HYP.
    5. History of human immunodeficiency virus or other immunodeficient conditions.
    6. MS relapse that has occurred within the 30 days prior to Day 1 AND/OR the subject has not stabilized from a previous relapse prior to
    Day 1.
    7. History of, or positive screening test for hepatitis C or hepatitis B infection.
    8. Varicella or herpes zoster virus infection within 6 weeks before screening.
    9. Exposure to varicella zoster virus within 21 days before screening.
    10. Any of the following abnormal blood tests at screening:
    • hemoglobin ≤9.0 g/dL, platelets ≤100 x 109/L ,lymphocytes ≤1.0 x 109/L, neutrophils ≤1.5  109/L
    • (ALT)/(ALT/SGPT), (AST)/ (AST/SGOT), or (GGT) ≥2 ×ULN)
    • serum creatinine ≥ULN
    Treatment History
    Any previous treatment with daclizumab or other anti-CD25 monoclonal antibody, total lymphoid irradiation, cladribine, T-cell or T-cell receptor
    vaccination or any therapeutic monoclonal antibody, except natalizumab.
    Any live virus vaccine within the 4 weeks prior to Day 1.
    12. Infections requiring hospitalization or IV antibiotics within the 8 weeks prior to Day 1.
    13. Elective surgery performed within the 2 weeks prior to Day 1 or scheduled through the end of the study.
    14. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to Day 1.
    15. Treatment with mitoxantrone, cyclophosphamide, fingolimod, or
    natalizumab within 1 year prior to Day 1.
    16. Treatment with any of the following medications or procedures within the 6 months prior to Day 1:
    • cyclosporine
    • azathioprine
    • methotrexate
    • mycophenolate mofetil
    • IV immunoglobulin (IVIg)
    • Plasmapheresis/ cytapheresis
    17. Treatment with any of the following medications within the 30 days prior to Day 1:
    • IV or oral corticosteroid treatment
    • glatiramer acetate
    18. For subjects currently taking valproic acid, carbamazepine,
    lamotrigine, or phenytoin:
    • Treatment with any of these agents ≤ 6 months prior to study entry
    • Treatment with 2 or more of these agents for more than 6 months prior to study entry are excluded unless they reduce to ≤1 agent prior to study entry.
    • Dose escalations of one of these agents within the 6 months prior to study entry are excluded
    Current treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry .
    Exclusion Criteria for 3-Year Treatment Extension
    1. Subjects who permanently discontinued DAC HYP treatment in Study 205MS302 for any reason prior to the 20 week washout period.
    2. ALT/SGPT, (AST/SGOT), or GGT ≥2xULN within 7 days prior to reinitiation of DAC HYP.
    Additional Exclusion Criteria for Specific TP-DI Sub-Study
    Subject permanently discontinued DAC HYP treatment in Study 205MS302 for any reason prior to Week 40.
    Subject is positive for NAbs at Week 36.
    Subject is on a regimen of therapeutic anticoagulation.
    Subject has narrow angle glaucoma.
    Use of any drug or supplement that inhibits or induces CYP1A2,
    CYP2C9, CYP2C19, CYP2D6, or CYP3A activity within 14 days or 5 halflives (whichever is longer) before the first dose of probe-drug cocktail.
    Consumption of grapefruit or grapefruit-containing products within 3 days before the first dose of probe-drug cocktail.
    History of gastrointestinal malabsorption conditions or bleeding.
    History of hypersensitivity to midazolam, caffeine, warfarin, vitamin K, dextromethorphan, or omeprazole.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of anti-DAC HYP binding antibodies
    (ADAbs) through week 44
    • Incidence of anti-DAC HYP neutralizing antibodies
    (NAbs) through week 44
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every study visit as indicated in the Study Events section of the protocol
    E.5.2Secondary end point(s)
    • Daclizumab population PK parameters including apparent clearance
    (CL/F) and apparent volume of distribution (V/F)
    • PK parameters for subjects in the intensive PK Sub-Study:
    o maximum concentration (Cmax)
    o time to reach maximum concentration (Tmax)
    o area-under-the-curve from start to end of the dosing interval (AUC)
    o trough concentrations (Ctrough)
    o apparent volume of distribution (V/F)
    o elimination half-life (t½)
    o apparent clearance (CL/F)
    • The following PK parameters for individual probe drugs will be
    determined for subjects in the TP-DI Sub Study:
    Primary:
    o area-under-the-curve from zero to infinity (AUC0–∞). If the
    extrapolated AUC >20%, AUC0-t where t is the time of last point with quantifiable data (tlast) may be considered if appropriate.
    o dextromethorphan to dextrorphan urine concentration ratio
    Secondary:
    o Cmax
    o CL/F
    o omeprazole/hydroxyomeprazole concentration ratio at 2 hours post-omeprazole dosing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daclizumab PK parameters: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 44, 48, 52, 56, 68, 80, 92, 104, 116, 128, 140, 152, 164, 176, 188

    Sub-study parameters: Weeks 0 and 20

    TP-DI Sub-Study paramaters: Weeks 43, 48, 52, and 53
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.7.1.3.1Other trial type description
    Immunogenicity
    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 No
    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 EEA19
    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
    Czech Republic
    Hungary
    Poland
    Russian Federation
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 100
    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 Decision2011-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-26
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