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    Summary
    EudraCT Number:2019-004980-36
    Sponsor's Protocol Code Number:MS200527ˍ0082
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-004980-36
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2)
    A.4.1Sponsor's protocol code numberMS200527ˍ0082
    A.5.4Other Identifiers
    Name:AcronymNumber:Evolution RMS 2
    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
    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+49 6151 72 5200
    B.5.5Fax number+49 6151 72 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 nameEvobrutinib
    D.3.2Product code M2951
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEVOBRUTINIB
    D.3.9.1CAS number 1415823-73-2
    D.3.9.2Current sponsor codeM2951
    D.3.9.3Other descriptive nameMSC2364447C
    D.3.9.4EV Substance CodeSUB188608
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Aubagio
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    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 nameAubagio
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    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 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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
    For the Double-blind Treatment Period (DBTP): To demonstrate superior efficacy with evobrutinib compared to Teriflunomide in terms of Annualized Relapse Rate (ARR)
    For the the Double-Blind Extension (DBE) Period: To further evaluate the
    efficacy with evobrutinib compared to teriflunomide in terms of
    Annualized Relapse Rate (ARR)
    For the Open Label Extension (OLE) Period: To evaluate the long-term
    safety and tolerability of evobrutinib 45 mg twice daily (BID) in
    participants with Relapsing Multiple Sclerosis (RMS) over time
    E.2.2Secondary objectives of the trial
    DBTP-to demonstrate the efficacy of evobrutinib relative to that of Teriflunomide: a.on disability progression (DP); b.on disability improvement; c.on patient reported symptoms and functional status;
    d.on magnetic resonance imaging (MRI) lesion parameters; e.by evaluating response on Neurofilament light chain (NfL) concentrations in serum; and f.to characterize the safety and tolerability of evobrutinib. DBE Period-to further evaluate the efficacy of evobrutinib relative to that
    of teriflunomide: a.on DP; b.on disability improvement; c.on patient reported symptoms and functional status; d.on MRI lesion parameters; and e.to further characterize the safety and tolerability of evobrutinib. OLE Period-to evaluate the long-term efficacy of evobrutinib 45mg BID:
    a.in participants with RMS; b.in participants with RMS on patient
    reported symptoms and functional status; c.to further evaluate the longterm
    safety and tolerability of evobrutinib 45mg BID in participants with
    RMS over time.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OLE period - secondary - MRI Substudy: To evaluate the long-term
    efficacy of evobrutinib 45 mg BID in participants with RMS on MRI
    parameters.
    OLE Period – exploratory - Biomarker Substudy: To further explore the
    long-term efficacy of evobrutinib 45 mg BID in participants with RMS by
    evaluating responses to biomarkers of disease (e.g., NfL)
    E.3Principal inclusion criteria
    For DBTP:
    - 18 years to 55 years female and male participants
    - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)
    - Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization
    - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
    - Participants are neurologically stable for >= 30 days prior to both screening and baseline
    - Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
    - Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
    - Participants have given written informed consent prior to any study-related procedure
    - Other protocol defined inclusion criteria could apply.
    For DBE period:
    - Participants need to be able and willing to provide written informed
    consent for the DBE period before the first procedure in DBE.
    - Participant does not fulfill any permanent discontinuation criteria
    based on Week 156/EODBTP assessments.
    For OLE period:
    - participants have completed the DBE Period, or are still under study
    treatment when enrollment into OLE is opened - but not into the longterm
    follow-up study -,and who, in the opinion of the Investigator, may
    benefit from treatment with evobrutinib.
    - participants are able and willing to provide written informed consent
    for the OLE period (e.g., before the first OLE procedure on OLE Day 1)
    and to comply with the study protocol.
    - participants have documentation of completed AEP (confirmed blood
    concentration level of < 0.02 μg/mL of teriflunomide as defined in
    protocol) before Day 1/Baseline visit (applicable to all participants
    previously treated with teriflunomide, or with an unknown exposure
    status during the DBTP and DBE period).
    - Women of childbearing potential are willing to continue to use the
    contraceptive methods as described in protocol
    E.4Principal exclusion criteria
    For DBTP:
    - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse.
    - Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening.
    - Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.
    -Other protocol defined exclusion criteria could apply.
    For OLE period:
    - Participants who did not complete study intervention in DBE period
    - Treatment with injectable (e.g., IV, intramuscular, intra-articular) or
    oral glucocorticoids, or ACTH (e.g., Acthar gel) within 30 days before
    OLE Day 1, with the exception of rescue treatment for MS relapse
    specified by the study protocol.
    - History of suicidal ideation or an episode of clinically severe depression
    (as determined by the Investigator) within 12 weeks prior to OLE Day 1.
    - History of abnormal laboratory results that, in the opinion of the
    Investigator, are indicative of a significant cardiac, endocrine,
    hematologic, immunologic, metabolic urologic, pulmonary,
    gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than
    MS), and/or other major diseases.

    - Any of the following abnormal blood tests during the DBE Period
    requiring discontinuation of study intervention, and/or at End of
    DBE visit, with a week before OLE Day 1: ALT/serum glutamate pyruvate
    transaminase, AST/serum glutamic oxaloacetic transaminase,Total
    Bilirubin, amylase,
    or lipase, eGFR.
    - Female participants who have a positive pregnancy test result, are
    pregnant, or are currently breast feeding.
    - Inability to comply with study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    For DBTP: ARR based on qualified relapses at up to 156 weeks in participants with RMS
    For DBE Period: ARR based on qualified relapses in participants with RMS
    For OLE period: Occurrence of AEs and SAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    For DBTP: up to 156 weeks
    For DBE Period: up to 96 weeks
    For OLE period: Entire OLE duration
    E.5.2Secondary end point(s)
    For DBTP:
    a. Time to first occurrence of 12-week confirmed disability progression (CDP) as measured by the Expanded Disability Status Scale (EDSS) up to 156 weeks
    b.Time to first occurrence of 24-week CDP as measured by EDSS up to 156 weeks
    c. Time to first occurrence of 24-week Confirmed Disability Improvement (CDI) as measured by the EDSS up to 156 weeks
    d.Change from Baseline (CFB) in Patient Reported Outcomes Measurement Information System [PROMIS] PF score over 96 weeks
    e.CFB in PROMIS Fatigue score over 96 weeks
    f.Total number of T1 Gd+ lesions based on on all available MRI scans
    g. Total number of new or enlarging T2 lesions on the last available MRI scan relative to the baseline MRI scan
    h. NfL concentration at 12 weeks
    i.Safety as assessed by the nature, severity, and occurrence of adverse events (AEs) and adverse events of special interest (AESIs); vital signs; electrocardiograms (ECGs); absolute concentrations and change from Baseline in immunoglobulin (Ig) levels; and clinical laboratory safety parameters up to the end of the safety follow-up period
    For DBE Period:
    a. Time to first occurrence of 12-week CDP as measured by EDSS
    b. Time to first occurrence of 24-week CDP as measured by EDSS
    c. Time to first occurrence of 24-week CDP as measured by the EDSS
    d. CFB in PROMIS PF score over time
    e. CFB in PROMIS Fatigue score over time
    f. Total number of T1 Gd+ lesions based on all available MRI scans
    g. Number of new or enlarging T2 lesions on the last available MRI scan
    relative to the baseline MRI scan
    h. Safety as assessed by the nature, severity, and occurrence of AEs and
    AESIs; vital signs; ECGs; absolute concentrations and CFB in Ig levels;
    and clinical laboratory safety parameters up to the end of the Safety
    Follow-up period.
    For OLE period:
    a. ARR based on protocol defined qualified relapses
    b. Time to first occurrence of 24-week CDP as measured by EDSS
    c. Time to first occurrence of 24-week CDI as measured by EDSS
    d. SDMT over time
    e. PROMISnq PF (MS) 15a score change over time
    f. PROMIS Fatigue (MS) 8a score change over time
    g. Safety Laboratory Parameters including Blood Chemistry, Hematology,
    Coagulation, Vitals, ECGs
    E.5.2.1Timepoint(s) of evaluation of this end point
    For DBTP:
    a. 12 week up to 156 weeks
    b.c 24-week up to 156 weeks
    d.e. over 96 weeks
    f: Total number of T1 Gd+ lesions based on all available MRI scans
    g. Number of new or enlarging T2 lesions on the last available MRI scan
    relative to the baseline MRI scan
    h. at 12 weeks
    i. end of the Safety Follow-up period
    For DBE period:
    a. at 12 weeks
    b., c. at 24 weeks
    d., e., f., g., h. for up to 96 weeks
    For OLE period:
    a., d., e., f., g. for up to 96 weeks
    b., c. 24-weeks
    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 Yes
    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.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 Yes
    E.8.1.7.1Other trial design description
    Active comparator (Aubagio), double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA129
    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
    Malaysia
    Philippines
    Singapore
    Tunisia
    Switzerland
    Moldova, Republic of
    Ukraine
    Puerto Rico
    Belarus
    Brazil
    Canada
    India
    Kuwait
    Mexico
    Russian Federation
    Saudi Arabia
    South Africa
    Thailand
    United States
    Bulgaria
    France
    Germany
    Greece
    Italy
    Latvia
    Lithuania
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    Sweden
    Türkiye
    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 years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months4
    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: 930
    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 state295
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 930
    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)
    After a subject has completed the study or has withdrawn early, the subject is free to access further treatment as deemed appropriate by the Treating Investigator. Additional care to subjects after they leave the study should not differ from the current standard of care available to patients with MS, and as such will not be provided by Merck Healthcare KgaA, an affiliate of Merck KGaA, Darmstadt, Germany
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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