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    Summary
    EudraCT Number:2020-005929-89
    Sponsor's Protocol Code Number:CLOU064C12302
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-21
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-005929-89
    A.3Full title of the trial
    A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
    Studiu randomizat, dublu-orb, cu mascarea formei terapeutice, cu grupuri paralele de comparare a eficacitatii si sigurantei remibrutinib fata de teriflunomida la participanti cu screloza multipla recurenta, urmat de tratament extins cu remibrutinib in regim deschis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib
    A.4.1Sponsor's protocol code numberCLOU064C12302
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services Romania S.R.L.
    B.5.2Functional name of contact pointRadu Boroghina – TMO Head Romania
    B.5.3 Address:
    B.5.3.1Street Address2 Gara Herastrau St., Equilibrium Complex, Building 1, Floor 10, Section E10.02, District 2
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code020334
    B.5.3.4CountryRomania
    B.5.4Telephone number+40 21 3129901
    B.5.5Fax number+40 21 3129907
    B.5.6E-mailradu_dan.boroghina@novartis.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 nameremibrutinib
    D.3.2Product code LOU064
    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 INNRemibrutinib
    D.3.9.2Current sponsor codeLOU064C
    D.3.9.4EV Substance CodeSUB204118
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameTeriflunomide
    D.3.4Pharmaceutical form Capsule, hard
    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 placeboFilm-coated tablet
    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 placeboCapsule, hard
    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
    Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    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 27.0
    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
    Core part:
    Demonstrate that remibrutinib is superior to teriflunomide in reducing the frequency of confirmed relapses
    E.2.2Secondary objectives of the trial
    Core Part key secondary objectives:
    Assess whether remibrutinib is superior to teriflunomide in
    ● Delaying disability progression based on the pooled data from both identical pivotal studies
    ● Reducing new inflammatory activity on MRI, based on MRI cohort data
    ● Reducing neuronal damage
    ● Disease-Activity-free status based on pooled data from both identical pivotal studies (MRI Cohort) Extension
    Core Part other secondary objectives:
    . To assess the effects of remibrutinib relative to teriflunomide on additional clinical and MRI endpoints
    . To assess the effect of remibrutinib relative to teriflunomide on the physical and psychological impact of MS
    . To assess the safety and tolerability of remibrutinib compared to teriflunomide
    . To assess the pharmacokinetics (PK) of remibrutinib
    Extension Part:
    . To assess long-term safety, tolerability and efficacy parameters in participants treated with remibrutinib
    Please see protocol for complete detailed list of objectives
    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) DNA sampling / Pharmacogenetics
    The study includes an optional genetic research component.
    The purpose of genetic research may be to better understand the safety and efficacy of remibrutinib, or to learn more about human diseases, or to help develop ways to detect, monitor and treat diseases.
    2) MRI Cohort
    Only selected sites will participate in the MRI cohort; it is planned that at least 400 participants will be included in this MRI cohort after signature of an additional (optional) consent. Eligible participants from these selected sites will undergo MRI scanning of the brain (see protocol for details).
    The purpose is to assess new inflammatory activity on MRI and Disease- Activity free status, based on the MRI cohort data.
    3) Additional Biomarker assessment
    Transcriptomic profiling may be assessed, using RNA from whole blood.
    mRNA expression patterns and patterns of other RNA species, will be derived from application of various technologies which may include sequencing of cDNA libraries related to the RNA extracted from blood.
    These analyses will be used to examine the effect of remibrutinib on transient RNA and may support the identification of pathways/markers that characterize the disease or response of treatment with remibrutinib.
    4) PK sub-study
    There are two pharmacokinetic assessments (PK) cohorts, for "rich" and "sparse" sampling. PK assessments are only performed during the Core Part of the study.
    All PK samples for remibrutinib from both the sparsely sampled and richly sampled subgroup of participants will be used to perform a population pharmacokinetics analysis.
    See protocol for more information on the sub-studies
    E.3Principal inclusion criteria
    1. Signed informed consent obtained prior to any assessment performed (confirm at screening visit)
    2. Male or female participants 18 to 55 years of age (inclusive) at screening
    3. Diagnosis of RMS according to the 2017 McDonald diagnostic criteria (this would include relapsing-remitting course (RRMS) or secondary progressive (SPMS) course with disease activity) as confirmed at screening visit.
    4. At least: 1 documented relapse within the previous year, OR 2 documented relapses within the previous 2 years, prior to screening, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months prior to screening
    5. EDSS score of 0 to 5.5 (inclusive) at screening and randomization
    6. Neurologically stable within 1 month prior to screening and randomization (including no MS relapse in this period)

    Please see protocol for complete detailed list of inclusion criteria
    E.4Principal exclusion criteria
    1. Diagnosis of primary progressive multiple sclerosis (PPMS)
    2. Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
    3. History of clinically significant CNS disease other than MS
    4. Ongoing substance abuse (drug or alcohol)
    5. History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
    6. Participants with history of confirmed Progressive Multifocal
    Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
    7. suicidal ideation or behavior
    8. Evidence of clinically significant cardiovascular, neurological,
    psychiatric, pulmonary , renal, hepatic, endocrine, metabolic,
    hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
    9. Participants who have had a splenectomy
    10. Active clinically significant systemic bacterial, viral, parasitic or fungal infections
    11. Positive results for syphilis or tuberculosis testing
    12. Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
    13. Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
    14. Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
    15. History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or participants with moderate or severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease.
    16. History of severe renal disease or creatinine level
    17. Participants at risk of developing or having reactivation of hepatitis
    18. Hematology parameters at screening:
    Hemoglobin: < 10 g/dl (<100g/L)
    Platelets: < 100000/mm3 (<100 x 109/L)
    Absolute lymphocyte count < 800/mm3 (<0.8 x 109/L)
    White blood cells: <3 000/mm3 (<3.0 x 109/L)
    Neutrophils: < 1 500/mm3 (<1.5 x 109/L)
    B-cell count < 50% lower limit of normal (LLN) or total IgG & total IgM < LLN (only required for participants who had a history of receiving B cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
    19. History or current diagnosis of significant ECG abnormalities
    20. Resting QTcF =450 msec (male) or =460 msec (female) at pre treatment (prior to randomization)
    21. Use of exclusionary medication prior to screening/randomization as defined in the protocol
    22. Use of other investigational drugs
    23. Requirement for anticoagulant medication or use of dual anti-platelet therapy
    24. Significant bleeding risk or coagulation disorders,
    25. History of gastrointestinal bleeding
    26. Major surgery within 8 weeks prior to screening
    27. History of hypersensitivity to any of the study drugs or excipients
    28. Pregnant or nursing (lactating) female participants, prior to
    randomization
    29. Women of childbearing potential not using highly effective
    contraception
    30. Sexually active males not agreeing to use condom
    31. Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
    32. Use of strong CYP3A4 inhibitors, or use of moderate or strong
    CYP3A4 inducers within two weeks prior to randomization
    Inclusion to Extension part:
    1. patient who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)
    Please see protocol for complete and more detailed list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Core part:
    Annualized relapse rate (ARR) of confirmed relapses
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 30 months
    E.5.2Secondary end point(s)
    Core part endpoints for key secondary objectives:
    ● Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS)
    ● Time to 6-month confirmed disability progression (6mCDP) on EDSS
    ● Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate)
    ● Total number of Gd-enhancing T1 lesions per MRI scan
    ● Neurofilament light chain (NfL) concentration in serum
    ● Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI
    Core part endpoints for other secondary objectives:
    . Time to first confirmed relapse
    . Time to 6-month confirmed disability improvement (6mCDI) on EDSS (pooled data)
    . Time to 3mCDP and 6mCDP independent of relapse activity (PIRA, pooled data)
    . Change from baseline in the Symbol Digit Modalities Test (SDMT) (pooled data)
    . Time to 6-month confirmed worsening by at least 20% in the: Timed 25-foot walk test (T25FW) (pooled data) and Timed 9-hole peg test (9HPT) (pooled data)
    . Time to composite 6-month confirmed disability progression, as evaluated by 6mCDP or 6-month confirmed worsening by at least 20% in T25FW or 9HPT (pooled data)
    . Change from baseline in T2 lesion volume
    . Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29)
    . Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
    . Remibrutinib blood concentrations
    Extension part endpoints for other secondary objectives:
    . Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
    . ARR, number of new or enlarging T2 lesions on MRI per year
    (annualized T2 lesion rate), time to 6mCDP (EDSS), change in SDMT, NfL, Patient Reported Outcomes scores
    Please see protocol for complete detailed list of endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 30 months for the core part endpoints, please refer to the protocol for detailed timepoints for all endpoints
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA88
    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
    Argentina
    Egypt
    Oman
    Tunisia
    Brazil
    Canada
    China
    India
    Mexico
    Morocco
    Russian Federation
    South Africa
    United Kingdom
    United States
    Bulgaria
    Croatia
    Czechia
    Estonia
    France
    Germany
    Greece
    Hungary
    Italy
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days17
    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: 800
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 453
    F.4.2.2In the whole clinical trial 800
    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)
    Participants who complete the core part of the study on study drug, can continue in the planned extension part. The investigator must provide follow-up medical care for all participants who do not enter the extension part or are prematurely withdrawn from the study, or must refer them for appropriate ongoing care.

    Please see protocol for more details.
    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 Decision2022-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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