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    Summary
    EudraCT Number:2021-003577-63
    Sponsor's Protocol Code Number:DYNAMICS_Study
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003577-63
    A.3Full title of the trial
    Effects of ozanimod on myelin dynamics and neurodegeneration in patients with relapsing-remitting multiple sclerosis: correlation with disease activity, cognition, fatigue, depression and quality of life
    Effetti di ozanimod sulle dinamiche della mielina e sulla neurodegeneratione nei pazienti con sclerosi multipla a ricadute e remissioni: correlazioni con l’attività di malattia, le funzioni cognitive, la fatica, la depressione e la qualità della vita
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of ozanimod on myelin dynamics and neurodegeneration in patients with relapsing-remitting multiple sclerosis: correlation with disease activity, cognition, fatigue, depression and quality of life
    Effetti di ozanimod sulle dinamiche della mielina e sulla neurodegeneratione nei pazienti con sclerosi multipla a ricadute e remissioni: correlazioni con l’attività di malattia, le funzioni cognitive, la fatica, la depressione e la qualità della vita
    A.3.2Name or abbreviated title of the trial where available
    DYNAMICS_Study
    DYNAMICS_Study
    A.4.1Sponsor's protocol code numberDYNAMICS_Study
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 58
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number00390226436920
    B.5.5Fax number0000000
    B.5.6E-mailctc@hsr.it
    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 nameozanimod cloridrato
    D.3.2Product code [ozanimod cloridrato]
    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 INNOzanimod
    D.3.9.1CAS number 1618636-37-5
    D.3.9.2Current sponsor codeOzanimod
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number460
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 nameozanimod cloridrato
    D.3.2Product code [ozanimod cloridrato]
    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 INNOzanimod
    D.3.9.1CAS number 1618636-37-5
    D.3.9.2Current sponsor codeOzanimod
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number230
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 nameOzanimod
    D.3.2Product code [Ozanimod]
    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 INNOzanimod
    D.3.9.1CAS number 1618636-37-5
    D.3.9.2Current sponsor codeOzanimod
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number920
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Multiple sclerosis patients in relapse and remission form
    Pazienti affetti da sclerosi multipla nella forma a ricadute e remissioni
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis patients in relapse and remission form
    Pazienti affetti da sclerosi multipla nella forma a ricadute e remissioni
    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 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
    The primary objective of this study is to evaluate the effects of ozanimod in RRMS patients in limiting the progression of brain neurodegenerative phenomena over the course of 2 years.
    L'obiettivo principale di questo studio è valutare gli effetti di ozanimod nei pazienti con sclerosi multipla a ricadute e remissioni nel limitare la progressione dei fenomeni neurodegenerativi cerebrali nel corso di 2 anni di trattamento.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effects of ozanimod treatment over the course of 2 years (at month 6, year 1 and year 2) in RRMS patients in the following terms:
    1. Preventing further demyelination and tissue damage and promoting remyelination and tissue recovery;
    2. Reducing the burden of chronic active lesions;
    3. The number of clinical relapses and the occurrence of disability progression/improvement;
    4. The longitudinal changes of cognitive performances, fatigue, depression, and QoL;
    5. The longitudinal changes of conventional MRI measures of disease activity;
    6. The longitudinal evolution of neuro-axonal damage;
    7. The associations between clinical, neuropsychological, MRI, and pNfL measures.
    Valutare gli effetti del trattamento con ozanimod nel corso di 2 anni (al mese 6, anno 1 e anno 2) nei pazienti con sclerosi multipla a ricadute e remissioni nei seguenti termini:
    1. Prevenire l'ulteriore demielinizzazione e danno tissutale e promuovere la rimielinizzazione e la riparazione tissutale;
    2. Ridurre il numero ed il volume delle lesioni della sostanza bianca cronicamente attive o ‘slowly-evolving lesions’;
    3. Il numero di recidive cliniche e l'insorgenza di progressione/miglioramento della disabilità;
    4. I cambiamenti longitudinali delle prestazioni cognitive, della fatica, della depressione e della qualità di vita;
    5. I cambiamenti longitudinali delle misure convenzionali di RM dell'attività della malattia (nuove lesioni iperintense in T2 e lesioni captanti il gadolinio);
    6. L'evoluzione longitudinale del danno neuro-assonale;
    7. Le associazioni tra misure cliniche, neuropsicologiche, di RM e dei livelli plasmatici delle catene leggere dei neurofilamenti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For RRMS patients:
    - Age between 18 and 55 years (in line with phase III RCTs);
    - A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;58
    - RRMS patients starting treatment with ozanimod, according to European Medicines Agency (EMA) and Italian Medicine Agency (AIFA) criteria (if available at the moment of study initiation);
    - EDSS score =5.0 (in line with phase III RCTs);
    - Planned vaccinations completed prior to enrollment;
    - Provide informed consent signed for participation in the trial;
    - Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.*

    * NOTE where the use of effective contraception is a protocol requirement a section on Contraception and Pregnancy should be added to the safety reporting section with corresponding information in the Participant Information Sheet.

    For HC subjects:
    - Age between 18 and 55 years;
    - Provide informed consent signed for participation in the trial.
    Età 18-55 anni, fenotipo clinico di malattia: sclerosi multipla a ricadute e remissioni, punteggio alla scala disabilità EDSS (Expanded Disability Status Scale) =5.0, nessun'altra malattia neurologica, psichiatrica o sistemica, nessuna storia di abuso di droghe/alcol, nessuna controindicazione ad essere sottoposti ad esami di RM.
    E.4Principal exclusion criteria
    For RRMS patients:
    - Age <18 or >55 years;
    - Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations;
    - Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
    - History of psychiatric or mood disorders, or of drug or alcohol abuse;
    - MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants;
    - One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start;
    - The participant has previously participated in any clinical trial of ozanimod;
    - The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized;
    - Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. (positive urine ß-subunit of human chorionic gonadotropin [HCG]).

    For HC subjects:
    - Age <18 or >55 years;
    - Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
    - History of psychiatric or mood disorders, or of drug or alcohol abuse;
    - MRI contraindications;
    - Female participant who is pregnant, lactating or planning pregnancy during the course of the trial (positive urine ß-subunit of HCG).
    Età <18 o >55 anni; fenotipi clinici di malattia: sclerosi multipla primariamente o secondariamente progressiva, punteggio alla scala disabilità EDSS (Expanded Disability Status Scale) >5.0, altre malattie neurologiche, psichiatriche o sistemiche, precedente storia di abuso di droghe/alcol, presenza di controindicazioni ad essere sottoposti ad esami di RM.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study are to assess, in RRMS patients treated with ozanimod, the changes from baseline over 2 years of:
    • Global brain atrophy (i.e., percent brain volume change [PBVC]);
    • Regional GM volume;
    • Regional WM volume;
    • Thalamic volume;
    • Cortical volume.
    Gli endpoint primari di questo studio sono valutare, nei pazienti con sclerosi multipla a ricadute e remissioni trattati con ozanimod, i cambiamenti rispetto al basale in 2 anni:
    • dell’atrofia cerebrale globale (ovvero, variazione percentuale del volume cerebrale);
    • del volume regionale della sostanza grigia cerebrale;
    • del volume regionale della sostanza bianca cerebrale;
    • del volume talamico;
    • del volume della corteccia cerebrale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 6, year 1 and year 2 after the start of treatment with ozanimod
    mese 6, anno 1 e anno 2 dopo l’inizio del trattamento con ozanimod
    E.5.2Secondary end point(s)
    4. Changes from baseline in cognitive profile (Brief Repeatable Battery of Neuropsychological Tests), in fatigue (Modified Fatigue Impact Scale [MFIS]), in depression (Montgomery and Asberg Depression Rating Scale [MADRS]), and in quality of life ( MSQOL-54);; 1. 2-year changes from baseline in magnetization transfer ratio values ¿¿in white matter lesions, gadolinium-enhancing lesions, apparently normal white matter, and gray matter from baseline across different time points at follow-up up;; 2. The number, volume and proportions of lesions defined or not as 'slowly-evolving lesions' and the evolution of their magnetization transfer ratio and T1 signal intensity values ¿¿to explore the dynamics of myelin content and axonal density within these lesions;; 3. Annualized relapse rate, worsening / improvement in Expanded Disability Status Scale (EDSS) score, change in Multiple Sclerosis Functional Compostive (MSFC) score, proportions of patients with relapsing multiple sclerosis and remissions without clinical relapses;; 5. Number of new / enlarged T2 hyperintense lesions on MRI of the brain; number of gadolinium-enhancing lesions; single combined activity; percentage of patients with relapse and remission multiple sclerosis without new / enlarged and / or gadolinium-enhancing T2 hyperintense lesions;
    6. Longitudinal variations in plasma levels of neurofilament light chains;; 6. Longitudinal variations in plasma levels of neurofilament light chains;; 7. Correlation between MRI measures, plasma levels of neurofilament light chains and clinical measures of disability, cognitive impairment, fatigue, depression and quality of life.
    4. Variazioni rispetto al basale del profilo cognitivo (Brief Repeatable Battery of Neuropsychological Tests), della fatica (Modified Fatigue Impact Scale [MFIS]), della depressione (Montgomery e Asberg Depression Rating Scale [MADRS]), e della qualità di vita (MSQOL-54);; 1. Le variazioni rispetto al basale in 2 anni dei valori del rapporto di trasferimento di magnetizzazione nelle lesioni della sostanza bianca, nelle lesioni captanti il gadolinio, nella sostanza bianca apparentemente normale e nella sostanza grigia rispetto al basale attraverso i diversi punti temporali al follow-up;; 2. Il numero, volume e proporzioni delle lesioni definite o meno come ‘slowly-evolving lesions’ e l'evoluzione dei loro valori di rapporto di trasferimento di magnetizzazione e intensità del segnale T1 per esplorare le dinamiche del contenuto di mielina e della densità assonale all'interno di queste lesioni;; 3. Tasso di recidive annualizzato, peggioramento/miglioramento dello score Expanded Disability Status Scale (EDSS), la variazione dello score Multiple Sclerosis Functional Compostive (MSFC), proporzioni di pazienti con sclerosi multipla a ricadute e remissioni senza ricadute cliniche;; 5. Numero di lesioni iperintense in T2 nuove/ingrandite alla RM dell’encefalo; numero di lesioni captanti il gadolinio; attività unica combinata; percentuale di pazienti con sclerosi multipla a ricadute e remissioni senza lesioni iperintense in T2 nuove/ingrandite e/o captanti il gadolinio;; 6. Variazioni longitudinali dei livelli plasmatici delle catene leggere dei neurofilamenti;; 7. Correlazione tra misure di RM, livelli plasmatici delle catene leggere dei neurofilamenti e misure cliniche di disabilità, deterioramento cognitivo, fatica, depressione e qualità della vita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.
    mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.; mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.; mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.; mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.; mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.; mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.; mese 6, anno 1 anno 2 dopo l’inizio del trattamento con ozanimod.
    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 No
    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 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 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.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    At the end of the study, all patients with relapsing multiple sclerosis and study remissions will continue to receive treatment with ozanimod according to the prescribing criteria defined by the Italian Medicines Agency, unless there is evidence of a lack of efficacy of the therapy or the presence of adverse events or safety problems related to the treatment itself.
    Al termine dello studio, tutti i pazienti con sclerosi multipla a ricadute e remissioni dello studio continueranno a ricevere il trattamento con ozanimod secondo i criteri di prescrivibilità definiti dall’Agenzia Italiana del Farmaco, salvo che si evidenzi una mancanza di efficacia della terapia o la presenza di eventi avversi o problemi di sicurezza legati al trattamento stesso.
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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