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    Summary
    EudraCT Number:2006-001947-70
    Sponsor's Protocol Code Number:MBP8298-RR-01
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-08
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-001947-70
    A.3Full title of the trial
    A Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis
    A.4.1Sponsor's protocol code numberMBP8298-RR-01
    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 Information not present in EudraCT
    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 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.3.9.1CAS 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 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 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
    Relapsing Remitting Multiple Sclerosis
    MedDRA Classification
    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 this study is to demonstrate efficacy - as measured with annualized relapse rate after 12 months treatment - and safety of MBP8298 versus placebo in subjects diagnosed with RRMS and who are positive for HLA DR2/4 haplotypes.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess efficacy and safety of MBP8298 versus placebo in subjects who are negative for HLA DR2/4 haplotypes and to assess in all subjects the time to confirmed worsening of disability as measured by EDSS and MSFC and the effects of MBP8298 on MRI parameters like
    • Activity analysis (T2 lesions, Gadolinium enhancing lesions)
    • Lesion burden (T2 burden of disease, chronic T1 black holes)
    • Brain Atrophy
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female subjects, 18-50 years of age
    2. Relapsing-remitting multiple sclerosis (RRMS) according to “Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria” (Annals of Neurology 58: 840-846)
    3. At least 2 years history of MS before trial entry
    4. Documented history of 2 or more exacerbations in the 2 years prior to trial entry
    5. Stable neurological status for at least 30 days before first study drug administration
    6. Have an EDSS from 0-5.5
    7. If female, she must either
    - be post-menopausal or surgically sterilized; or
    - use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
    - be neither pregnant nor breast-feeding
    8. Willingness and ability to comply with the protocol for the duration of the study
    9. In the Investigator’s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
    10. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
    E.4Principal exclusion criteria
    1. Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)
    2. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma
    3. Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC),
    4. Clinically significant ECG abnormalities at screening
    5. Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
    6. Have current autoimmune disease, compromised immune function or infection
    7. History of allergic reactions to glatiramer acetate
    8. Steroid therapy within 30 days prior to first study specific procedure, or any other treatment known to be used for putative or experimental MS treatment
    9. Therapy with ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test
    10. Therapy with 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
    11. Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20,
    12. Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium-DTPA
    13. Participation in any other trial of an investigational agent within 90 days prior to screening
    14. History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening
    15. 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
    16. 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)
    Primary efficacy endpoints:
    The primary efficacy endpoint is the annualized relapse rate after 12 months of treatment.
    The secondary efficacy endpoints:
    A. Main Secondary endpoints
    a. Clinical related endpoints
    Disability related
    Disability progression defined as the time to confirmed worsening of disability as measured by EDSS and MSFC at 12 24 and 27 months
    Exacerbation (relapse) related
    • Proportion of subjects relapse-free at 12, 24 and 27 months
    b. MRI related endpoints
    • Number of active lesions per subject per scan defined as new T1 gadolinium-enhancing, or new T2 non-enhancing or enlarging lesions at all MRI follow-up visits (designated “combined unique activity”)
    • Number of active T2 lesions per subject per scan at the end of first and second year
    • Number of active T1 gadolinium-enhanced lesions per subject per scan at the end of first and second year
    B. Other secondary endpoints (exploratory)
    a. Clinical related endpoints
    Exacerbation (relapse) related
    • Number of hospitalizations because of exacerbation at 12, 24 and 27 months
    • Duration of exacerbations
    • Severity of exacerbations as assessed with EDSS
    • Time to first exacerbation
    • Time to second exacerbation
    • Time from first to second exacerbation
    • Number of steroid courses for relapse treatment at 12, 24 and 27 months
    • Proportion of DR2/4 +ve and DR2/4 –ve subjects in the RRMS population
    Disability related
    • Integrated disability status scale (IDSS = area under the EDSS curve above baseline value) at 12, 24 and 27 months
    • Time to disability progression
    QOL
    • Functional Assessment of Multiple Sclerosis (FAMS) (Cella DF et al. 1996) at 6, 12, and 27 months
    b. MRI related endpoints
    • Proportion of subjects with no active T2 lesions at 12 and 24 months
    • Proportion of subjects with no active T1 gadolinium-enhanced lesions 12 and 24 months
    • Change in T2-weighted lesion volume 12 and 24 months
    • Change in T1-weighted hypointense lesion volume 12 and 24 months
    • Brain volume change, as measured by MRI, 12 and 24 months
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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) Information not present in EudraCT
    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 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 2006-08-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 215
    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 Decision2006-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-25
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