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    Clinical Trial Results:
    A 24-month, open-label, prospective, multicenter, interventional, single-arm study assessing the efficacy and safety of fingolimod (Gilenya) 0.5 mg in relapsing multiple sclerosis (RMS) patients in China

    Summary
    EudraCT number
    		 2024-000601-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Mar 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Sep 2025
    First version publication date
    06 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTY720D2419
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04667949
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Lichtstrasse 36, Basel, Switzerland, 4056
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to to evaluate the efficacy of fingolimod 0.5 mg on annualized relapse rate (ARR) in participants with RMS treated for up to 24 months.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 98
    Worldwide total number of subjects
    98
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    2
    Adolescents (12-17 years)
    9
    Adults (18-64 years)
    87
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 13 sites in China

    Pre-assignment
    Screening details
    		 There were up to 30 days of screening period (day -30 to -1) before first treatment (day 1).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fingolimod (< 18 years)
    Arm description
    		 Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fingolimod
    Investigational medicinal product code
    FTY720
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Fingolimod 0.5 mg capsule taken orally once daily

    Arm title
    		 Fingolimod > 18 years
    Arm description
    		 Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fingolimod
    Investigational medicinal product code
    FTY720
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Fingolimod 0.5 mg capsule taken orally once daily

    Number of subjects in period 1
    		Fingolimod (< 18 years) Fingolimod > 18 years
    Started
    11
    87
    Completed
    10
    75
    Not completed
    1
    12
         Physician decision
    -
    2
         Subject decision
    1
    7
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fingolimod (< 18 years)
    Reporting group description
    		 Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old

    Reporting group title
    Fingolimod > 18 years
    Reporting group description
    		 Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over

    Reporting group values
    		 Fingolimod (< 18 years) Fingolimod > 18 years Total
    Number of subjects
    		 11 87 98
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 2 0 2
        Adolescents (12-17 years)
    		 9 0 9
        Adults (18-64 years)
    		 0 87 87
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.8 ( 1.60 ) 32.3 ( 9.11 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 3 51 54
        Male
    		 8 36 44
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 11 87 98
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 0 0 0
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Number of relapses in the last 12 months prior to screening
    Units: relapses/year
        arithmetic mean (standard deviation)
    		 1.7 ( 1.27 ) 1.2 ( 0.47 ) -
    Number of relapses in 12 to 24 months prior to screening
    Units: relapses/year
        arithmetic mean (standard deviation)
    		 0.8 ( 1.25 ) 0.7 ( 0.84 ) -

    End points

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    End points reporting groups
    Reporting group title
    Fingolimod (< 18 years)
    Reporting group description
    		 Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old

    Reporting group title
    Fingolimod > 18 years
    Reporting group description
    		 Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over

    Primary: Adjusted Annualized relapse rate (ARR) in adult group

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    End point title
    		 Adjusted Annualized relapse rate (ARR) in adult group [1] [2]
    End point description
    A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician. The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects’ time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained. As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs.
    End point type
    Primary
    End point timeframe
    Baseline to Month 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical hypothesis testing was planned for this primary endpoint
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per SAP this analysis was only performed for the Adult group.
    End point values
    		 Fingolimod > 18 years
    Number of subjects analysed
    87
    Units: relapses per participan-year
        number (confidence interval 95%)
    0.018 (0.006 to 0.061)
    No statistical analyses for this end point

    Secondary: Number of participants with treatment emergent Adverse events (AE) and serious adverse events (SAE)

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    End point title
    		 Number of participants with treatment emergent Adverse events (AE) and serious adverse events (SAE)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study. For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment to 45 days after last study dose up to approximately 25.5 months
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    11
    87
    Units: participants
        Adverse events (AEs)
    11
    86
        Study treatment related AEs
    10
    81
        Serious adverse events (SAEs)
    3
    12
        AEs leading to interruption of study treatment
    3
    11
        AEs leading to study discontinuation
    1
    5
        AEs leading to death
    0
    0
    No statistical analyses for this end point

    Secondary: Annualized rate of the number of new or newly enlarged T2 lesions

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    End point title
    		 Annualized rate of the number of new or newly enlarged T2 lesions [3]
    End point description
    Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable. The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset. Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment (up to Month 24)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per SAP this analysis was only performed for the Adult group.
    End point values
    		 Fingolimod > 18 years
    Number of subjects analysed
    81
    Units: Lesions per participant-year
        number (confidence interval 95%)
    1.316 (0.762 to 2.272)
    No statistical analyses for this end point

    Secondary: Change from baseline in number of new or newly enlarged T2 lesions

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    End point title
    		 Change from baseline in number of new or newly enlarged T2 lesions
    End point description
    Number of new/newly enlarged T2 lesions since baseline as measured by MRI
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    10
    81
    Units: new / newly enlarged T2 lesions
    arithmetic mean (standard deviation)
        12 months
    1.8 ( 1.93 )
    1.8 ( 4.18 )
        24 months
    2.1 ( 2.18 )
    2.4 ( 4.84 )
    No statistical analyses for this end point

    Secondary: Change from baseline in T2 lesion volume

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    End point title
    		 Change from baseline in T2 lesion volume
    End point description
    T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    10
    79
    Units: milliliters
    median (full range (min-max))
        12 months
    0.6140 (-17.607 to 34.748)
    0.3930 (-6.343 to 25.158)
        24 months
    -1.6736 (-17.100 to 36.719)
    0.4065 (-5.741 to 26.322)
    No statistical analyses for this end point

    Secondary: Number of Gd-enhancing T1 lesions per scan in adult group

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    End point title
    		 Number of Gd-enhancing T1 lesions per scan in adult group [4]
    End point description
    Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable. The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset. MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per SAP this analysis was only performed for the Adult group.
    End point values
    		 Fingolimod > 18 years
    Number of subjects analysed
    80
    Units: Lesions per participant per scan
        number (confidence interval 95%)
    0.376 (0.216 to 0.655)
    No statistical analyses for this end point

    Secondary: Number of Gd-enhancing T1 lesions

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    End point title
    		 Number of Gd-enhancing T1 lesions
    End point description
    Number of Gd-enhancing T1 lesions as measured by MRI
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    10
    79
    Units: T1 lesions
    arithmetic mean (standard deviation)
        12 months
    0.4 ( 0.70 )
    0.4 ( 0.84 )
        24 months
    0 ( 0.00 )
    0.4 ( 1.83 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Gd-enhancing T1 lesion volume

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    End point title
    		 Change from baseline in Gd-enhancing T1 lesion volume
    End point description
    Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    10
    79
    Units: microliters
    median (full range (min-max))
        12 months
    -56.0 (-1392.5 to 418.0)
    0.00 (-1869.0 to 546.0)
        24 months
    -56.0 (-632.7 to 0.0)
    0.00 (-1869.0 to 1082.0)
    No statistical analyses for this end point

    Secondary: Number of T1 hypo-intense lesions

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    End point title
    		 Number of T1 hypo-intense lesions
    End point description
    Number of T1 hypo-intense lesions as measured by MRI
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    10
    79
    Units: T1 hypo-intense lesions
    arithmetic mean (standard deviation)
        12 months
    14.6 ( 12.97 )
    17.0 ( 13.62 )
        24 months
    13.4 ( 10.86 )
    16.7 ( 13.27 )
    No statistical analyses for this end point

    Secondary: Change from baseline in T1 hypo-intense lesion volume

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    End point title
    		 Change from baseline in T1 hypo-intense lesion volume
    End point description
    T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    10
    79
    Units: microliters
    median (full range (min-max))
        12 months
    -77.500 (-6849.30 to 20341.80)
    44.000 (-4921.30 to 19035.00)
        24 months
    -641.415 (-7444.50 to 1161.50)
    187.100 (-5772.20 to 19264.00)
    No statistical analyses for this end point

    Post-hoc: Participant based Annualized relapse rate (ARR)

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    End point title
    		 Participant based Annualized relapse rate (ARR)
    End point description
    A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Participant-based ARR was calculated by taking the total number of relapses observed for a participant divided by the total number of days in study of that participant and multiplied by 365.25.
    End point type
    Post-hoc
    End point timeframe
    Baseline to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    11
    87
    Units: relapses per participant-year
    arithmetic mean (standard deviation)
        All relapses - Participant based
    0.1952 ( 0.50314 )
    0.0969 ( 0.50002 )
        Confirmed relapses - Participant based
    0.0460 ( 0.15253 )
    0.0372 ( 0.24424 )
    No statistical analyses for this end point

    Post-hoc: Time based Annualized relapse rate (ARR)

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    End point title
    		 Time based Annualized relapse rate (ARR)
    End point description
    A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Time-based ARR was calculated by taking the total number of relapses observed for all subjects within an age group divided by the total number of days in study of all subjects within the group and multiplied by 365.25 days.
    End point type
    Post-hoc
    End point timeframe
    Baseline to Month 24
    End point values
    		 Fingolimod (< 18 years) Fingolimod > 18 years
    Number of subjects analysed
    11
    87
    Units: relapses per participant-year
    number (not applicable)
        All relapses - Time based
    0.161
    0.065
        Confirmed relapses - Time based
    0.054
    0.019
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Less than 18 years
    Reporting group description
    		 Less than 18 years

    Reporting group title
    Overall
    Reporting group description
    		 Overall

    Reporting group title
    Greater than or equal to 18 years
    Reporting group description
    		 Greater than or equal to 18 years

    Serious adverse events
    		 Less than 18 years Overall Greater than or equal to 18 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    15 / 98 (15.31%)
    12 / 87 (13.79%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Fractured sacrum
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 98 (1.02%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 98 (1.02%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute disseminated encephalomyelitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 98 (1.02%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 98 (2.04%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 98 (1.02%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion complete
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 98 (1.02%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 98 (1.02%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 98 (2.04%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 98 (3.06%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 98 (2.04%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Less than 18 years Overall Greater than or equal to 18 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    96 / 98 (97.96%)
    85 / 87 (97.70%)
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 98 (3.06%)
    2 / 87 (2.30%)
         occurrences all number
    1
    3
    2
    Chest discomfort
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 98 (4.08%)
    3 / 87 (3.45%)
         occurrences all number
    2
    6
    4
    Pyrexia
         subjects affected / exposed
    4 / 11 (36.36%)
    16 / 98 (16.33%)
    12 / 87 (13.79%)
         occurrences all number
    6
    20
    14
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 11 (18.18%)
    12 / 98 (12.24%)
    10 / 87 (11.49%)
         occurrences all number
    4
    16
    12
    Psychiatric disorders
    Initial insomnia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 11 (18.18%)
    35 / 98 (35.71%)
    33 / 87 (37.93%)
         occurrences all number
    3
    59
    56
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 11 (9.09%)
    20 / 98 (20.41%)
    19 / 87 (21.84%)
         occurrences all number
    1
    28
    27
    Blood cholesterol increased
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    1
    2
    1
    Electrocardiogram PR shortened
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 98 (4.08%)
    3 / 87 (3.45%)
         occurrences all number
    1
    4
    3
    Electrocardiogram ST segment abnormal
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Electrocardiogram high voltage
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    3
    3
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    10 / 98 (10.20%)
    10 / 87 (11.49%)
         occurrences all number
    0
    12
    12
    Liver function test abnormal
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 98 (2.04%)
    0 / 87 (0.00%)
         occurrences all number
    4
    4
    0
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 11 (18.18%)
    55 / 98 (56.12%)
    53 / 87 (60.92%)
         occurrences all number
    2
    91
    89
    Lymphocyte percentage decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    8 / 98 (8.16%)
    7 / 87 (8.05%)
         occurrences all number
    1
    12
    11
    Monocyte count increased
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 11 (18.18%)
    6 / 98 (6.12%)
    4 / 87 (4.60%)
         occurrences all number
    2
    6
    4
    Neutrophil percentage increased
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    1
    3
    2
    Platelet count increased
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 98 (3.06%)
    2 / 87 (2.30%)
         occurrences all number
    1
    3
    2
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Protein urine present
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 98 (3.06%)
    1 / 87 (1.15%)
         occurrences all number
    3
    4
    1
    Urinary sediment present
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Weight increased
         subjects affected / exposed
    4 / 11 (36.36%)
    12 / 98 (12.24%)
    8 / 87 (9.20%)
         occurrences all number
    4
    13
    9
    Weight decreased
         subjects affected / exposed
    5 / 11 (45.45%)
    13 / 98 (13.27%)
    8 / 87 (9.20%)
         occurrences all number
    5
    15
    10
    White blood cell count decreased
         subjects affected / exposed
    4 / 11 (36.36%)
    26 / 98 (26.53%)
    22 / 87 (25.29%)
         occurrences all number
    7
    48
    41
    White blood cell count increased
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    1
    2
    1
    White blood cells urine positive
         subjects affected / exposed
    2 / 11 (18.18%)
    10 / 98 (10.20%)
    8 / 87 (9.20%)
         occurrences all number
    3
    14
    11
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 11 (0.00%)
    13 / 98 (13.27%)
    13 / 87 (14.94%)
         occurrences all number
    0
    15
    15
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 11 (9.09%)
    5 / 98 (5.10%)
    4 / 87 (4.60%)
         occurrences all number
    1
    5
    4
    Headache
         subjects affected / exposed
    2 / 11 (18.18%)
    12 / 98 (12.24%)
    10 / 87 (11.49%)
         occurrences all number
    4
    18
    14
    Seizure
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Syncope
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    2
    3
    1
    Blood and lymphatic system disorders
    Hypoglobulinaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 98 (3.06%)
    2 / 87 (2.30%)
         occurrences all number
    1
    3
    2
    Leukopenia
         subjects affected / exposed
    5 / 11 (45.45%)
    27 / 98 (27.55%)
    22 / 87 (25.29%)
         occurrences all number
    10
    45
    35
    Neutropenia
         subjects affected / exposed
    3 / 11 (27.27%)
    5 / 98 (5.10%)
    2 / 87 (2.30%)
         occurrences all number
    4
    7
    3
    Lymphopenia
         subjects affected / exposed
    7 / 11 (63.64%)
    31 / 98 (31.63%)
    24 / 87 (27.59%)
         occurrences all number
    9
    44
    35
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    1
    2
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Ocular hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Refraction disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Strabismus
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    3
    4
    1
    Diarrhoea
         subjects affected / exposed
    3 / 11 (27.27%)
    8 / 98 (8.16%)
    5 / 87 (5.75%)
         occurrences all number
    3
    9
    6
    Haematemesis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 98 (3.06%)
    1 / 87 (1.15%)
         occurrences all number
    5
    6
    1
    Nausea
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 98 (3.06%)
    1 / 87 (1.15%)
         occurrences all number
    2
    3
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 11 (0.00%)
    10 / 98 (10.20%)
    10 / 87 (11.49%)
         occurrences all number
    0
    11
    11
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 11 (0.00%)
    6 / 98 (6.12%)
    6 / 87 (6.90%)
         occurrences all number
    0
    6
    6
    Nail bed inflammation
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Hair colour changes
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Neurodermatitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Urine abnormality
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    2
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 98 (1.02%)
    0 / 87 (0.00%)
         occurrences all number
    6
    6
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 11 (36.36%)
    13 / 98 (13.27%)
    9 / 87 (10.34%)
         occurrences all number
    5
    16
    11
    Gingivitis
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 98 (2.04%)
    1 / 87 (1.15%)
         occurrences all number
    1
    2
    1
    COVID-19
         subjects affected / exposed
    2 / 11 (18.18%)
    37 / 98 (37.76%)
    35 / 87 (40.23%)
         occurrences all number
    3
    39
    36
    Pharyngitis
         subjects affected / exposed
    4 / 11 (36.36%)
    4 / 98 (4.08%)
    0 / 87 (0.00%)
         occurrences all number
    4
    4
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 11 (36.36%)
    25 / 98 (25.51%)
    21 / 87 (24.14%)
         occurrences all number
    12
    43
    31
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    16 / 98 (16.33%)
    16 / 87 (18.39%)
         occurrences all number
    0
    24
    24
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    9 / 98 (9.18%)
    9 / 87 (10.34%)
         occurrences all number
    0
    11
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Aug 2020
    • Added detailed pulmonary function monitoring guidance. • Updated the description of severe uncontrolled respiratory disease in pulmonary function test. • Revised the Liver Safety Monitoring Guidance according to the China fingolimod label. • Clarified the ECG requirement for baseline and first dose monitoring. • Clearly defined the 6m-CDP as measured by EDSS. • Updated protocol to adapt to the ongoing COVID-19 pandemic.
    11 Oct 2021
    • Introduced the measures in response to public health emergencies (e.g. COVID-19 pandemic). • Updated the ophthalmic guidance on diagnosis of macular edema.• Removed the maximum 5 days requirement for the use of corticosteroids. • Removed proton density in the efficacy assessment. • Changed the language regarding new findings in MRI images. • Clarified the detailed definition of highly effective contraception.
    13 Jun 2023
    • Clarified and detailed the identification and situation when EOS visit was required in the study. • Described more clearly about the analysis of T2 lesion-related MRI parameters that were analyzed as secondary endpoints. • Updated language to align with the Novartis protocol template Version 5.0.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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