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    Summary
    EudraCT Number:2013-002916-28
    Sponsor's Protocol Code Number:EMR200166-001
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-16
    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 ConcernedLatvia - SAM
    A.2EudraCT number2013-002916-28
    A.3Full title of the trial
    An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis
    A.4.1Sponsor's protocol code numberEMR200166-001
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+49615172 5200
    B.5.5Fax number+49615172 2000
    B.5.6E-mailservice@merckgroup.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 nameATX-MS-1467
    D.3.2Product code MSC2358825A
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSC2304479A
    D.3.9.1CAS number 1147979-29-0
    D.3.9.2Current sponsor codeATX-MS-01
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSC2304480A
    D.3.9.1CAS number 1147979-31-4
    D.3.9.2Current sponsor codeATX-MS-04
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSC2304481A
    D.3.9.1CAS number 1147979-32-5
    D.3.9.2Current sponsor codeATX-MS-06
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSC2304482A
    D.3.9.1CAS number 1147979-30-3
    D.3.9.2Current sponsor codeATX-MS-07
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Relapsing 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10067063
    E.1.2Term Progressive relapsing 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 trial is to evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 μg every 2 weeks (biweekly), for a total period of 20 weeks on 1.5T MRI parameters compared to a Baseline Control Period off treatment in subjects with relapsing MS.
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 μg biweekly, for a total period of 20 weeks on other MRI parameters
    - To evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 μg biweekly, for a total period of 20 weeks on clinical parameters
    - To evaluate the safety of ATX-MS-1467 administered intradermally, titrated to a dose of 800 μg biweekly, for a total period of 20 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female out-patients (except where an in-patient stay is required according to standard local practice for lumbar puncture) aged 18 to 65 years of age inclusive at the time of informed consent
    2. Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures
    3. Relapsing MS
    4. Clinical evidence of recent MS activity defined as either
    - at least one documented relapse in the previous 12 months prior to Visit 2, or
    - at least two documented relapses in the previous 24 months prior to Visit 2.
    5. Radiological activity on Gd-enhanced MRI defined as both
    - at least one CEL on MRI at Visit 2, and
    - an increase of at least one CEL from Visit 2 to Visit 4, i.e., over the 8-week Baseline Control Period.
    6. EDSS score 0-5.5
    7. HLA-DRB1*15 positive
    8. Neurological stability in the 30 days prior to Visit 5 (Study Day 1)
    9. Prior vaccination against tuberculosis (TB)
    10. If female, unless post-menopausal (for at least 2 years) or surgically sterilized, must be willing to use two highly effective methods of contraception throughout the entire duration of
    the trial and for 90 days following the last dose of ATX-MS-1467
    11. If male, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467.
    E.4Principal exclusion criteria
    1. Primary progressive MS
    2. Inability to comply with MRI scanning, including contra-indications to MRI such as known allergy to gadolinium contrast dyes, claustrophobia, presence of a pacemaker, cochlear
    implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, nerve stimulators
    3. Previous treatment with β-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to Study Day 1 (Visit 5); subjects receiving such treatment at Visit 2 (i.e.,
    at the start of the Baseline Control Period) must discontinue treatment and commence washout as soon as it has been confirmed that they are eligible for the trial based on their
    Visit 2 MRI scan
    4. Previous treatment with steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan; subjects
    receiving such treatment at screening (Visit 1) must have completed treatment 30 days prior to the Visit 2 MRI scan
    5. Previous treatment with glatiramer acetate
    6. Previous treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod,
    teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab, ocrelizumab)
    7. Prior exposure to dimethyl fumurate (BG-12) or dirucotide
    8. Prior exposure to any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467
    9. Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1)
    10. Inadequate liver function, defined by aspartate aminotransferase or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening or at any of the pre-treatment visits (Visits 2-4)
    11. Lymphocyte count < 500/μL or neutrophil count < 1500/μL at screening or at any of the pre-treatment visits (Visits 2-4)
    12. Major medical illness such as cardiac, endocrinological, hepatic, immunological (other than MS), metabolic, genito-urinary, pulmonary, gastrointestinal, dermatological, or other major
    disease that would preclude participation in the trial
    13. Known history of active or chronic infectious disease or any disease which compromises immune function (e.g., positive for human immunodeficiency virus, human T-lymphotrophic
    virus-1, untreated Lyme disease, untreated TB or hepatic viral disease [hepatitis B and C])
    14. Any renal condition that would preclude the administration of gadolinium, e.g., acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] < 30 mL/min/1.73 m2)
    15. History of malignancy, including both solid tumor and hematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised
    and resolved, in situ cervical cancer or prostatic cancer with normal prostatic specific antigen
    16. Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt
    17. Any other significant medical or psychiatric conditions that, in the opinion of the Investigator, would preclude participation in the trial or impair the ability to give informed consent
    18. Major surgery in the 4 weeks prior to screening (Visit 1)
    19. Known hypersensitivity to the trial medication or diluents
    20. Participation in another clinical trial within the 30 days prior to screening (Visit 1)
    21. Pregnancy, lactation or a positive pregnancy test during screening (urine dipstick) or at Visit 4 (serum beta-human chorionic gonadotrophin [beta-hCG]), or intention to become
    pregnant or to breast-feed during the course of the trial
    22. Legal incapacity or limited legal capacity.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in the average number of T1 CEL at the last three on-treatment scans (Weeks 12, 16 and 20) compared to the average number of T1 CEL at the three baseline scans (Visits, 2, 3 and 4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 2, 3, 4, 12, 16 and 20
    E.5.2Secondary end point(s)
    - Total number of T1 CEL at each scheduled post-baseline MRI visit
    - Change from baseline (average of the three baseline scans, Visits 2, 3 and 4) in total number of T1 CEL at each scheduled post-baseline MRI visit
    - Change from baseline (average of the three baseline scans, Visits 2, 3 and 4) in total volume of T1 CEL at each scheduled post-baseline MRI visit
    - Total number of new or newly enlarging T2 lesions at each scheduled post-baseline MRI visit
    - Change from Visit 4 in total number of T1 CEL at each scheduled post-baseline MRI visit
    - Change from Visit 4 in total volume of T1 CEL at each scheduled post-baseline MRI visit
    - Mean ARR at Week 20
    - Time to first relapse
    - Change from baseline in total EDSS score at Week 20
    - Change from baseline in total MSFC score at Week 20
    - Nature, frequency and severity of TEAEs
    - Frequency and severity of ISRs
    - Vital signs, physical examination, clinical laboratory variables, and ECGs, as well as the frequency and timing of premature termination from the trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Wweeks 2, 3, 4 and 20
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Latvia
    Russian Federation
    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
    Completion of database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months27
    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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 20
    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)
    Usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    In addition, appropriate care should be available for all subjects who enter the Baseline Control
    Period and commence washout after the Visit 2 MRI scan but who are subsequently found not to
    be eligible for enrolment, e.g., due to a lack of disease activity on MRI at Visit 4.
    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 Decision2013-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-11
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