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    Summary
    EudraCT Number:2018-000284-93
    Sponsor's Protocol Code Number:Mapi_GADepotPhaseIII-001
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-02
    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 ConcernedEstonia - SAM
    A.2EudraCT number2018-000284-93
    A.3Full title of the trial
    A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
    Rahvusvaheline, mitmekeskuseline, randomiseeritud, topeltpime, paralleelrühmadega, platseebo-kontrollitud III faasi uuring hindamaks iga nelja nädala järel intramuskulaarselt süstitava pika toimeajaga glatirameeratsetaadi (GA Depot) efektiivsust, ohutust ja taluvust hulgiskleroosi ägenevate vormidega (RMS) uuringus osalejatel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
    A.4.1Sponsor's protocol code numberMapi_GADepotPhaseIII-001
    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 SponsorMapi Pharma Ltd.
    B.1.3.4CountryIsrael
    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 supportMapi Pharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMapi Pharma Ltd.
    B.5.2Functional name of contact pointUri Danon
    B.5.3 Address:
    B.5.3.1Street Address16 Einstein St.
    B.5.3.2Town/ cityNess-Ziona
    B.5.3.3Post code74140
    B.5.3.4CountryIsrael
    B.5.4Telephone number972737121213
    B.5.5Fax number97289100154
    B.5.6E-mailUri@mapi-pharma.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 nameGA Depot
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLATIRAMER ACETATE
    D.3.9.1CAS number 147245-92-9
    D.3.9.2Current sponsor codeGLATIRAMER ACETATE
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) 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 No
    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 placeboPowder for suspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing forms of Multiple Sclerosis (RMS)
    E.1.1.1Medical condition in easily understood language
    Relapsing forms of Multiple Sclerosis (RMS)
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term 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
    To assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks, as compared to placebo in a study design of 52 weeks’ duration.
    E.2.2Secondary objectives of the trial
    To assess the long-term safety and tolerability of GA Depot, in subjects treated for up to 104 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult subjects between 18-55 years of age, inclusive.
    2. Subjects able to provide signed written informed consent.
    3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
    4. MS diagnosis fulfilling the 2017 McDonald Criteria.
    5. Subjects should be ambulatory with an EDSS score of 0-5.5 at screening and baseline visits. EDSS score will be determined by a separate, blinded trained EDSS rater.
    6. Subjects should be relapse free and neurologically stable from one month before screening visit and from screening visit to baseline visit.
    7. No systemic corticosteroid treatment or ACTH within one month prior to screening visit.
    8. Subjects must have experienced at least one of the following:
    i. One documented relapse in the 12 months prior to screening.
    ii. Two documented relapses in the 24 months prior to screening.
    iii. One documented relapse between 12 and 24 months prior to screening, with at least one documented T1-Gd enhancing lesion in MRI performed within 0-12 months before screening.
    9. Women capable of child bearing must have a negative urine pregnancy test at screening visit and use an adequate contraceptive method throughout the study.
    E.4Principal exclusion criteria
    1. Use of experimental / investigational drug, and / or participation in drug clinical studies within the 6 months prior to screening.
    2. Any off-label drug use for MS treatment such as high dose simvastatin and biotin within 6 months prior to screening.
    3. Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, cladribine or any other cytotoxic agent.
    4. Previous use of natalizumab or any anti-B cell agent within 9 months prior to screening.
    5. Previous use of Fingolimod or Dimethyl Fumarate within 2 months prior to screening. Subjects will be excluded if they do not have a lymphocyte count of above 1,000/mm3 at screening.
    6. Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used.
    7. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
    8. Previous use of GA or any other glatiramoid.
    9. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
    10. Previous total body irradiation or total lymphoid irradiation.
    11. Previous stem-cell treatment, autologous bone marrow transplantation or allogeneic bone marrow transplantation.
    12. Subjects with a clinically significant or unstable medical, psychiatric, or surgical conditions that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG and/or abnormal laboratory tests. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy, or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
    13. Subjects who have >10 T1-Gd enhancing lesions at screening.
    14. A known history of sensitivity to Gadolinium.
    15. Inability to successfully undergo MRI scanning.
    16. Pregnant or breast-feeding women.
    17. Abnormal renal function (serum creatinine 1.5xULN or creatinine clearance <60 ml/min).
    18. Abnormal liver function (transaminases >2xULN).
    19. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study article (e.g., GA, Polyglactin, PVA).
    20. A history of positive VDRL or positive testing for HIV, hepatitis, or tuberculosis.
    21. Known or suspected history of drug or alcohol abuse.
    22. Subjects diagnosed with any systemic autoimmune disease (other than MS) that may impact the CNS with MS like lesions such as Sarcoidosis, Sjögren's syndrome, Systemic Lupus Erythematosus (SLE), Lyme disease, Antiphospholipid antibodies (APLA) syndrome, etc. Subjects with stable local/organ autoimmune disease such as psoriasis, cutaneous lupus erythematosus, thyroiditis (Hashimoto's, Grave's) etc. may be considered eligible upon the investigator's discretion.
    23. Any CNS disorder other than MS that may jeopardize the subject's participation in the study.
    24. Subjects with uncontrolled diabetes.
    25. Subjects with clotting disorders or receiving treatment with anticoagulants .
    E.5 End points
    E.5.1Primary end point(s)
    Annualized Relapse Rate (ARR) during the 52 weeks of the PC period as derived from the total number of confirmed relapses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 52 weeks of the PC period
    E.5.2Secondary end point(s)
    1. Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
    2. Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
    3. Change from baseline to Week 52 in hyperintense T2-lesion volume.
    4. Change from baseline to Week 52 in enhancing T1-lesion volume.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the 52 weeks of the PC period
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belarus
    Bosnia and Herzegovina
    Bulgaria
    Croatia
    Czech Republic
    Estonia
    Georgia
    Israel
    Macedonia, the former Yugoslav Republic of
    Moldova, Republic of
    Montenegro
    Poland
    Romania
    Russian Federation
    Serbia
    Ukraine
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 960
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 960
    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)
    None
    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 Decision2019-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-13
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