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    Clinical Trial Results:
    Multicenter, Randomized, Double-blind, Parallel-group, Add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects with Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera)

    Summary
    EudraCT number
    2012-000541-12
    Trial protocol
    DE   PT   DK   HU   CZ   AT   ES   GR   BG   FR   PL   FI   BE   HR  
    Global end of trial date
    30 Mar 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Apr 2021
    First version publication date
    08 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC-058B302
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02907177
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Actelion Pharmaceuticals Ltd
    Sponsor organisation address
    Gewerbestrasse 16, Allschwil, Switzerland, 4123
    Public contact
    Clinical Registry Group, Actelion Pharmaceuticals Ltd, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Actelion Pharmaceuticals Ltd, ClinicalTrialsEU@its.jnj.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to determine whether add-on therapy with ponesimod reduced relapse frequency as compared to placebo in subjects with active Relapsing Multiple Sclerosis (RMS) who were treated with dimethyl fumarate (DMF) (Tecfidera).
    Protection of trial subjects
    The study was conducted in full compliance with ICH-GCP guidelines, the principles of the “Declaration of Helsinki” and with the laws and regulations of the country in which the research is conducted. Safety evaluations included adverse events assessment through out the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 12
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Czechia: 33
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Greece: 10
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    136
    EEA total number of subjects
    106
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    136
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total 136 subjects were randomized,68 in both arms (ponesimod 20mg plus DMF [dimethyl fumarate] & placebo plus DMF). Of 136 subjects,107 (50 in ponesimod 20mg plus DMF; 57 in placebo plus DMF) completed study till early termination.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ponesimod plus dimethyl fumarate (DMF)
    Arm description
    Subjects were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.
    Arm type
    Experimental

    Investigational medicinal product name
    Ponesimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ponesimod 2-10 mg was administered as per titration sequence once daily from Day 1 to 14. Ponesimod 20 mg was administered once daily as maintenance dose from Day 15 to Week 156.

    Investigational medicinal product name
    dimethyl fumarate (DMF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject continued receiving DMF as background therapy.

    Arm title
    Placebo plus dimethyl fumarate (DMF)
    Arm description
    Subjects received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching Placebo was administered as per titration sequence once daily from Day 1 to 14 and maintenance dose from Day 15 to Week 156.

    Investigational medicinal product name
    dimethyl fumarate (DMF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject continued receiving DMF as background therapy.

    Number of subjects in period 1
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Started
    68
    68
    Treated
    67
    68
    Randomized analysis set
    68
    68
    Completed
    0
    0
    Not completed
    68
    68
         Sponsor's Decision
    50
    57
         Physician decision
    3
    3
         Withdrawal by subject
    15
    7
         Adverse event, serious fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ponesimod plus dimethyl fumarate (DMF)
    Reporting group description
    Subjects were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.

    Reporting group title
    Placebo plus dimethyl fumarate (DMF)
    Reporting group description
    Subjects received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.

    Reporting group values
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF) Total
    Number of subjects
    68 68 136
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    68 68 136
        From 65 to 84 years
    0 0 0
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    37.8 ± 9.1 38.1 ± 9.1 -
    Title for Gender
    Units: subjects
        Female
    43 46 89
        Male
    25 22 47

    End points

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    End points reporting groups
    Reporting group title
    Ponesimod plus dimethyl fumarate (DMF)
    Reporting group description
    Subjects were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.

    Reporting group title
    Placebo plus dimethyl fumarate (DMF)
    Reporting group description
    Subjects received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.

    Primary: Annualized Confirmed Relapse Rate (ARR)

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    End point title
    Annualized Confirmed Relapse Rate (ARR)
    End point description
    Relapse:occurrence of acute episode of one or more new worsened symptoms of Multiple sclerosis(MS),not linked to fever/infection, lasting 24 hours after stable 30 days.Confirmed relapse: increase from baseline at least 0.5 Expanded Disability Status Scale(EDSS) score or one point in 1, 2 or 3 Functional Systems(FS),excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination(NE) for rating its impairment in MS. Among 8 FS, 7 are ordinal clinical rating scales range 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder functions.Rating individual FS scores used to rate EDSS in link with observations, information concerning gait and use of assistance. EDSS is ordinal clinical rating scale from 0 (normal NE) to 10(deaths).Full Analysis Set (FAS) included all randomized subjects who had at least one dose of study treatment and post baseline efficacy assessment.
    End point type
    Primary
    End point timeframe
    From randomization up to End of Study
    End point values
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Number of subjects analysed
    66 [1]
    67 [2]
    Units: Relapses per year
        arithmetic mean (confidence interval 95%)
    0.237 (0.144 to 0.391)
    0.187 (0.109 to 0.322)
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Ponesimod plus dimethyl fumarate (DMF) v Placebo plus dimethyl fumarate (DMF)
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5252
    Method
    Negative binomial regression
    Parameter type
    Treatment effect (Rate Ratio)
    Point estimate
    1.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.608
         upper limit
    2.654

    Secondary: 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate (Percentage of Subjects at Week 96)

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    End point title
    12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate (Percentage of Subjects at Week 96)
    End point description
    12-Week CDA as assessed by Kaplan Meier estimate (Percentage of Subjects Week 96) was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for subjects with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for subjects with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS). FAS included all randomized subjects who had at least one dose of study treatment and had one post baseline efficacy assessment. Subjects were analyzed according to randomized treatment.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Number of subjects analysed
    66 [3]
    67 [4]
    Units: Percentage of subjects with a CDA
        number (confidence interval 95%)
    18.7 (8.7 to 37.6)
    11.9 (4.6 to 28.8)
    Notes
    [3] - FAS
    [4] - FAS
    No statistical analyses for this end point

    Secondary: Time to First Confirmed Relapse as Assessed by Kaplan Meier Estimate (Percentage of Subjects at Week 96)

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    End point title
    Time to First Confirmed Relapse as Assessed by Kaplan Meier Estimate (Percentage of Subjects at Week 96)
    End point description
    Time to First Confirmed Relapse as Assessed by Kaplan Meier Estimate (Percentage of Subjects at Week 96) was reported. The time to first confirmed relapse (in days) is defined as [Date of first confirmed relapse minus Date of randomization plus 1] in days. FAS included all randomized subjects who were treated with at least one dose of study treatment and had at least one post baseline efficacy assessment. Subjects were analyzed according to randomized treatment.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Number of subjects analysed
    66 [5]
    67 [6]
    Units: Percentage of subjects
        number (confidence interval 95%)
    33.6 (19.5 to 53.8)
    25.7 (13.4 to 46.1)
    Notes
    [5] - FAS
    [6] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) as a Measure of Safety and Tolerability

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    End point title
    Number of Subjects With Adverse Events (AEs) as a Measure of Safety and Tolerability
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Safety Analysis Set (SAF) includes all subjects who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 147 Weeks
    End point values
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Number of subjects analysed
    67
    68
    Units: Number of Subjects
    48
    53
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to End of treatment + 15 days (maximum up to 147 Weeks)
    Adverse event reporting additional description
    Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all subjects who received at least one dose of study treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Ponesimod plus dimethyl fumarate (DMF)
    Reporting group description
    Subjects were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.

    Reporting group title
    Placebo plus dimethyl fumarate (DMF)
    Reporting group description
    Subjects were up-titrated during Days 1 to 14 and maintenance dose form Day 15 to end of treatment with matching placebo once daily. In addition, subjects also continued receiving DMF capsules, orally, as background therapy.

    Serious adverse events
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 67 (8.96%)
    7 / 68 (10.29%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Multiple Injuries
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Nausea
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Testicle Adenoma
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Right Ventricular Failure
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Sclerosis Relapse
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary Retention
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Exostosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis Bacterial
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia Influenzal
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Pseudomonal
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Ponesimod plus dimethyl fumarate (DMF) Placebo plus dimethyl fumarate (DMF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 67 (67.16%)
    41 / 68 (60.29%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 68 (1.47%)
         occurrences all number
    6
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 67 (10.45%)
    1 / 68 (1.47%)
         occurrences all number
    7
    1
    Headache
         subjects affected / exposed
    6 / 67 (8.96%)
    6 / 68 (8.82%)
         occurrences all number
    7
    9
    Paraesthesia
         subjects affected / exposed
    0 / 67 (0.00%)
    6 / 68 (8.82%)
         occurrences all number
    0
    7
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 68 (5.88%)
         occurrences all number
    4
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 67 (5.97%)
    7 / 68 (10.29%)
         occurrences all number
    4
    7
    Back Pain
         subjects affected / exposed
    2 / 67 (2.99%)
    6 / 68 (8.82%)
         occurrences all number
    2
    7
    Pain in Extremity
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 68 (5.88%)
         occurrences all number
    4
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 67 (7.46%)
    3 / 68 (4.41%)
         occurrences all number
    5
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 67 (8.96%)
    13 / 68 (19.12%)
         occurrences all number
    11
    16
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 67 (4.48%)
    7 / 68 (10.29%)
         occurrences all number
    3
    7
    Urinary Tract Infection
         subjects affected / exposed
    4 / 67 (5.97%)
    5 / 68 (7.35%)
         occurrences all number
    5
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2017
    The main reasons for the amendment are to make the following changes to inclusion criterion: 1) To include the presence of at least one new or one unequivocally enlarging T2 lesion on magnetic resonance imaging (MRI) of the brain or spinal cord as an alternative criterion of disease activity. In order to assess this alternative criterion, two MRI scans have to be compared; the first MRI scan must be performed within 15 months prior to Visit 1 (Screening) and after at least 3 months of dimethyl fumarate (DMF) treatment; the second MRI scan must be performed prior to randomization (i.e., MRI performed at Visit 2 [Baseline] may be used). The presence of at least one new or one unequivocally enlarging MRI T2 lesion has to be confirmed by the central MRI reading facility prior to randomization of the subject. 2) To include the presence of MRI T1 gadolinium-enhancing (Gd+) lesions observed on the pre-randomization MRI scan of the brain as an alternative criterion of disease activity.

    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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