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    Summary
    EudraCT Number:2004-002571-16
    Sponsor's Protocol Code Number:MBP8298-01 Amendment 04
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-05
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2004-002571-16
    A.3Full title of the trial
    A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberMBP8298-01 Amendment 04
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorBioMS Technology Corp
    B.1.3.4CountryCanada
    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 numberN/A
    D.3 Description of the IMP
    D.3.1Product nameMBP8298 Synthetic Peptide
    D.3.2Product code MBP8298
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot known
    D.3.9.1CAS number 781666-30-6
    D.3.9.2Current sponsor codeMBP8298
    D.3.9.3Other descriptive nameMBP8298 Synthetic Peptide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 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 Information not present in EudraCT
    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
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondary progressive multiple sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive 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
    To compare the clinical efficacy of 500 mg MBP8298 given intravenously every six months for a period of two years, to placebo, in subjects diagnosed with SPMS who are positive for the HLA DR2 and/or DR4 haplotype. Clinical efficacy is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.
    E.2.2Secondary objectives of the trial
    •To assess safety of MBP8298 synthetic peptide in all subjects irrespective of genotype.
    •To compare the clinical efficacy of 500 mg MBP8298 given intravenously every six months for a period of two years, to placebo, in subjects diagnosed with SPMS who are negative for the HLA DR2 and/or DR4 haplotype.
    •To assess the effects of MBP8298 on MRI parameters.
    •To confirm that treatment with MBP8298 induces immunological tolerance or shift in functional response profile to MBP peptide (82-98) and determine whether this is dependent on HLA subtype
    •To determine whether MBP8298 induces immunological tolerance or shift in functional response profile to other MBP epitopes and other myelin antigens (e.g. PLP, MOG) indicating the stop of epitope spreading and whether this too is dependent on HLA subtype.
    •To confirm the ratio of HLA DR2/4 positive to HLA DR2/4 negative subjects in the SPMS population.
    •To determine whether MBP8298 improves the quality of life of SPMS patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects, 18-65 years of age,

    2. Documented history of SPMS. SPMS is defined as an MS patient who has been diagnosed with MS for at least 3 years, and in the 3 year period prior to enrolment must have documented progression of their pyramidal or cerebellar Kurtzke functional subscores (FSS). (In the absence of documented FSS changes, clinical notes documenting changes consistent with these changes will be acceptable). The subject must also have experienced at least 1 acute relapse as part of their diagnosis of RRMS. Only one relapse prior to diagnosis of MS can be in accordance with the McDonald diagnostic criteria as long as cranial MRI findings consistent with the diagnosis of MS are also present.
    3. Absence of relapse in the 3 months prior to baseline.

    4. EDSS of 3 . 5 – 6 . 5.

    5. Pyramidal or Cerebellar FSS ≥ 3

    6. A cohort of 100 HLA DR2/4 negative patients is required. Once enrollement to this cohort is complete, all further patients are required to be HLA DR2/4 positive.

    7. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements,

    8. In the Investigator’s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations.
    E.4Principal exclusion criteria
    1. Diagnosis of Primary Progressive MS.

    2. Subjects have previously received MBP8298.

    3. A recent history of malignancy, with the exclusion of basal cell carcinoma. All patients with a history of malignancy must be discussed, approved and a waiver issued by the Sponsors' Medical Monitor prior to randomisation.

    4. Steroid therapy within 30 days prior to first dose, or any other treatment known to be used for putative or experimental MS treatment.

    5. Therapy with ß-interferon, glatiramer acetate within 3 months, mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.

    6. Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period.

    7. History of anaphylactic/anaphylactoid reactions to glatiramer acetate,

    8. Abnormal laboratory values at the Baseline Visit deemed by the Investigator to be clinically significant.

    9. Known allergy to Gadolinium-DTPA.

    10. Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20.

    11. Treatment at any time with an altered peptide ligand.

    12. Any conditions that could interfere with the performance of study specific procedures e.g. MRI.

    13. Previous randomization to this study.

    14. Known positivity for HIV, Hepatitis B, or Hepatitis C.

    15. Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test (the screening/baseline visit), or any investigational therapy in the past 6 months.

    16. Females who are breast feeding, pregnant (pregnancy test at Screening), or not using a medically approved method of contraception regularly.

    17. Known or suspected current or past alcohol or drug abuse (within the last year).

    18. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.

    19. Any other condition that, in the Investigator’s opinion, makes the subject unsuitable for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    N/A
    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) Yes
    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.8.1.7.1Other trial design description
    N/A
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-05. Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    N/A
    F.3.3.7Others No
    F.3.3.7.1Details of other specific vulnerable populations
    N/A
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 553
    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)
    N/A
    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 Decision2006-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-22
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