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    Summary
    EudraCT Number:2020-003995-42
    Sponsor's Protocol Code Number:MS700568_0157
    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:2020-12-14
    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 number2020-003995-42
    A.3Full title of the trial
    A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS)
    2-letnie badanie uzupełniające, mające na celu ocenę długoterminowej skuteczności Mavenclad® u uczestników, którzy ukończyli badanie MS700568_0022 (MAGNIFY MS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension to the MAGNIFY MS trial on Mavenclad®
    Przedłużenie badania MAGNIFY MS dotyczącego leku Mavenclad®
    A.3.2Name or abbreviated title of the trial where available
    Magnify MS Extension
    A.4.1Sponsor's protocol code numberMS700568_0157
    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 Healthcare 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 Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare 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 codeD-64293
    B.5.3.4CountryGermany
    B.5.4Telephone number49615172 5200
    B.5.5Fax number49615172 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 Yes
    D.2.1.1.1Trade name Mavenclad
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCladribine tablets
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Highly-active relapsing multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    multiple sclerosis (MS)
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080700
    E.1.2Term 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
    To evaluate the long-term disease activity during Year 3 and 4 after initial dose of cladribine tablets
    E.2.2Secondary objectives of the trial
    1. To further explore the long-term treatment effect of cladribine tablets;
    2. To evaluate the long-term safety of cladribine tablets
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Blood biomarker sub-study (appendix 3 of main study protocol), v. 1.0 , 20 Aug 2020
    Objectives:
    • To describe changes in biomarkers over time during the extension study period (Year 3 and 4 since the initial dose of cladribine tablets)
    • To describe changes in biomarkers in Year 1, 2, 3, and 4 since the initial dose of cladribine tablets
    • To describe the correlation of biomarkers with “traditional” MS related assessments (e.g. MRI and EDSS).

    2. CSF Biomarker sub-study (appendix 4 of main study protocol), v. 1.0, 20 Aug 2020
    Objectives:
    • To describe the changes in CSF biomarkers at Year 3 and year 4 after treatment with cladribine tablets, compared to the extension study’s baseline
    • To describe the changes in CSF biomarkers at Year 1, 2, 3, and 4 after treatment with cladribine tablets, compared to the parent study baseline
    • To describe the correlation of biomarkers with ‘traditional’ MS related assessments (e.g. MRI and EDSS)
    • To describe changes in biomarker over time

    3. COVID-19 sub-study (appendix 5 of main study protocol) v. 1.0, 20 Aug 2020
    Objectives:
    • To describe the changes in antibody titers against COVID-19
    • To describe the changes in immune cell subtypes in those who show positive serology test
    • To describe the MS disease outcome and study endpoints collected in those who show positive serology test
    • To describe changes in antibody titers against COVID-19 vaccine (if available and administered, as per standard of care)
    • To describe changes in antibody titers against any vaccine (if available and administered, as per standard of care)
    E.3Principal inclusion criteria
    1. Participants of the MAGNIFY MS trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on MRI is available/acquired from at least parent study Month 18 or Month 24 visit and EDSS and relapse from parent study Month 24 visit.
    2. Capable of giving signed informed consent, as indicated in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
    E.4Principal exclusion criteria
    1. Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
    2. Participation in other studies/trials.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with No Evidence of Disease Activity (three parameter [NEDA-3]) during Year 3 and 4 after the initial dose of cladribine tablets.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1: 12 months (+/- 30 days) after parent study last visit
    Visit 2: 24 months (+/- 30 days) after parent study last visit
    E.5.2Secondary end point(s)
    • Proportion of participants with NEDA-3 during Year 3 after the initial dose of cladribine tablets
    • Proportion of participants with NEDA-3 during Year 4 after the initial dose of cladribine tablets
    • Proportion of participants with NEDA-3 after the onset of action of cladribine treatment during the parent study until the end of Year 3 after initial dose of cladribine tablets
    • Proportion of participants with NEDA-3 after onset of action of cladribine treatment during the parent study until the end of Year 4 after the initial dose of cladribine tablets
    • Proportion of participants remaining NEDA-3 during Year 3 or 4 after the initial dose of cladribine tablets among those with NEDA-3 during Year 1 or 2 after the initial dose of cladribine tablets
    • Time to first disease activity, defined as time to first occurrence of either qualifying relapse, or confirmed disability progression (CDP), or new or enlarging T2-hyperintense lesions, or new T1 gadolinium enhancing (Gd+) lesions, during Year 3 and 4 after the initial dose of cladribine tablets
    • Time to first disease activity, defined as time to first occurrence of either qualifying relapse, or CDP, or new or enlarging T2-hyperintense lesions, or new T1 Gd+ lesions, over 4 years after the initial dose of cladribine (i.e., between the initial dose of cladribine tablets and end of the extension study)
    • Time from the initial dose of cladribine tablets to
    - first new or enlarging T2 lesion
    - first new T1 Gd+ lesion
    - first CDP, as measured by Expanded Disability Status Scale (EDSS)
    - first qualifying relapse
    - second qualifying relapse
    - treatment start with other disease modifying drugs (DMDs)
    • Time from extension study Baseline to
    - first new or enlarging T2 lesion
    - first new T1 Gd+ lesion
    - first CDP, as measured by EDSS
    - first qualifying relapse
    - second qualifying relapse
    - treatment start with other DMDs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1: 12 months (+/- 30 days) after parent study last visit
    Visit 2: 24 months (+/- 30 days) after parent study last visit
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Phase IV extension; no IMP treatment during this study
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Australia
    Canada
    Israel
    E.8.7Trial has a data monitoring committee No
    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 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 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: 256
    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 2020-12-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 224
    F.4.2.2In the whole clinical trial 256
    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)
    Not applicable
    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 Decision2021-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-21
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