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    Clinical Trial Results:
    A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)

    Summary
    EudraCT number
    		 2018-001808-11
    Trial protocol
    		 FR   GB   DE   ES   HU   BG   PL   GR   IT   RO  
    Global end of trial date
    25 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2023
    First version publication date
    23 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ID-064A202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03742037
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Idorsia Pharmaceuticals Ltd
    Sponsor organisation address
    Hegenheimermattweg 91, Allschwil, Switzerland, 4123
    Public contact
    Idorsia Clinical Trial Information, Idorsia Pharmaceuticals Ltd, +41 58 844 1977, idorsiaclinicaltrials@idorsia.com
    Scientific contact
    Idorsia Clinical Trial Information, Idorsia Pharmaceuticals Ltd, +41 58 844 1977, idorsiaclinicaltrials@idorsia.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
    25 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of 6 months' cenerimod treatment given at 4 different dose levels (0.5, 1, 2, and 4 mg once daily) on disease activity in adult subjects with moderate to severe SLE concurrently receiving background therapy.
    Protection of trial subjects
    Prior to the start of the study, each study site consulted an Independent Ethics Committee (IEC) or Institutional Review Board (IRB), i.e., a review panel that was responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation. The protocol and any materials provided to the subject (such as a subject information sheet or description of the study used to obtain informed consent) were reviewed and approved by the appropriate IEC or IRB before the study was started. Sponsor personnel and the investigators were required to conduct the study in full compliance with ICH-GCP Guidelines, the principles of the Declaration of Helsinki, and with the laws and regulations in the country in which the study is conducted. The sponsor had the right to terminate the study at any time globally or locally. The investigators had the right to terminate the participation of their site in the study at any time. The investigator was responsible for protecting the subject's best interests. Study-specific criteria for discontinuation were described in the protocol. The investigators were responsible for maintaining the subjects' identities in strictest confidence. Written informed consent was required to be obtained from each individual participating in the study prior to any study procedure and after adequate explanation of the aims, methods, objectives, and potential hazards of the study. It was made clear to each subject that he or she was completely free to refuse to enter the study, or to withdraw from the study at any time for any reason.
    Background therapy
    		 To be eligible for this study, subjects must have been on stable doses of one or more of the following systemic lupus erythematosus (SLE) background medications: • Non-steroidal anti-inflammatory drugs, • Anti-malarials, • Mycophenolate mofetil, • Mycophenolic acid, • Azathioprine, • Methotrexate, • Corticosteroids, • Belimumab. Treatment with anti-malarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. All other background SLE therapies must have been started at least 30 days prior to Screening. Background SLE therapy doses must be stable for at least 30 days prior to Randomization. For corticosteroids, doses must be stable for at least 15 days prior to Randomization
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2018
    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
    Poland: 21
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Chile: 18
    Country: Number of subjects enrolled
    Georgia: 15
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Mexico: 39
    Country: Number of subjects enrolled
    Philippines: 27
    Country: Number of subjects enrolled
    Russian Federation: 24
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    Ukraine: 150
    Country: Number of subjects enrolled
    United States: 88
    Worldwide total number of subjects
    427
    EEA total number of subjects
    59
    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)
    415
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was done from 21 December 2018 to 25 August 2022.

    Pre-assignment
    Screening details
    		 427 participants are considered to be enrolled in the study and were randomized to study treatment.

    Period 1
    Period 1 title
    Treatment period 1 (TP1)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cenerimod 0.5 mg
    Arm description
    		 Subjects received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Cenerimod 1 mg
    Arm description
    		 Subjects received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Cenerimod 2 mg
    Arm description
    		 Subjects received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Cenerimod 4 mg
    Arm description
    		 Subjects received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomized to receive placebo once daily in addition to background SLE therapy for up to to 6 months.
    Arm type
    		 Placebo

    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
    Subjects received placebo, with the same excipients but without the active ingredient cenerimod, tablets once daily preferably in the morning.

    Number of subjects in period 1
    		Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Placebo
    Started
    85
    85
    86
    85
    86
    Completed
    78
    78
    71
    70
    77
    Not completed
    7
    7
    15
    15
    9
         Adverse event, serious fatal
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    4
    1
    2
    2
    4
         pre-specified criteria
    1
    3
    7
    6
    1
         Adverse event, non-fatal
    -
    1
    4
    3
    2
         No study treatment administered
    -
    -
    -
    1
    -
         Other reasons
    2
    -
    2
    2
    1
         Lost to follow-up
    -
    1
    -
    1
    -
         Lack of efficacy
    -
    -
    -
    -
    1
    Period 2
    Period 2 title
    Treatment period 2 (TP2)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cenerimod 0.5 mg
    Arm description
    		 Subjects completing treatment period 1 continued to receive cenerimod 0.5 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Cenerimod 1 mg
    Arm description
    		 Subjects completing treatment period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Cenerimod 2 mg
    Arm description
    		 Subjects completing treatment period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Cenerimod 2 mg (Ex 4 mg)
    Arm description
    		 Half the subjects completing treatment with cenerimod 4 mg in treatment period 1 were re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during treatment period 2. Subjects received cenerimod 2 mg for up to 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenerimod
    Investigational medicinal product code
    ACT-334441
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of cenerimod was taken once daily, preferably in the morning.

    Arm title
    		 Placebo (Ex 4 mg)
    Arm description
    		 Half the subjects completing treatment with cenerimod 4 mg in treatment period 1 were re-randomized to placebo once daily in addition to background SLE therapy during treatment period 2. Subjects received placebo for up to 6 months.
    Arm type
    		 Placebo

    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 identical to the cenerimod tablet was taken once daily, preferably in the morning.

    Arm title
    		 Placebo
    Arm description
    		 Subjects completing treatment period 1 continued to receive placebo once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.
    Arm type
    		 Placebo

    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 identical to the cenerimod tablet was taken once daily, preferably in the morning.

    Number of subjects in period 2
    		Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 2 mg (Ex 4 mg) Placebo (Ex 4 mg) Placebo
    Started
    78
    78
    71
    35
    35
    77
    Completed
    74
    74
    59
    30
    35
    68
    Not completed
    4
    4
    12
    5
    0
    9
         Consent withdrawn by subject
    -
    -
    2
    2
    -
    1
         pre-specified criteria
    -
    1
    3
    2
    -
    2
         Adverse event, non-fatal
    1
    2
    3
    1
    -
    4
         Other reasons
    2
    -
    2
    -
    -
    1
         Lost to follow-up
    -
    1
    2
    -
    -
    -
         Lack of efficacy
    1
    -
    -
    -
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cenerimod 0.5 mg
    Reporting group description
    		 Subjects received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Cenerimod 1 mg
    Reporting group description
    		 Subjects received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Cenerimod 2 mg
    Reporting group description
    		 Subjects received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Cenerimod 4 mg
    Reporting group description
    		 Subjects received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo once daily in addition to background SLE therapy for up to to 6 months.

    Reporting group values
    		 Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Placebo Total
    Number of subjects
    		 85 85 86 85 86 427
    Age categorical
    Units: Subjects
        Between 18 and 45 years
    		 49 54 49 50 57 259
        Between 45 and 64 years
    		 31 29 36 33 27 156
        Between 64 and 75 years
    		 5 2 1 2 2 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ( 12.41 ) 40.0 ( 12.77 ) 42.2 ( 12.06 ) 42.1 ( 10.44 ) 41.0 ( 11.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 79 83 80 82 82 406
        Male
    		 6 2 6 3 4 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 5 3 6 1 3 18
        Asian
    		 5 9 7 6 6 33
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 1 1
        Black or African American
    		 3 6 8 10 6 33
        White
    		 72 67 65 65 68 337
        Unknown or Not Reported
    		 0 0 0 3 2 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 16 17 18 19 19 89
        Not Hispanic or Latino
    		 69 68 68 65 66 336
        Unknown or Not Reported
    		 0 0 0 1 1 2
    Body Mass Index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 25.67 ( 5.67 ) 25.55 ( 5.95 ) 26.16 ( 6.6 ) 26.82 ( 7.15 ) 26.49 ( 6.24 ) -
    modified SLEDAI-2K at baseline
    The SLEDAI-2K is a weighted, cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, 0 indicates inactive disease and the maximum theoretical score is 105 (Gladman D et al. J Rheumatol 2002;29;288-291). In this study the SLEDAI-2K was modified, to exclude leucopenia (1 point), due to the mechanism of action of cenerimod. A score of 6 or greater is clinically relevant and associated with requiring lupus-directed therapy (Nuttall A et al. Best Pract Res Clin Rheumatol. 2013 Jun; 27(3):309-18).
    Units: Units of a scale
        arithmetic mean (standard deviation)
    		 9.8 ( 2.69 ) 10.1 ( 3.71 ) 9.5 ( 2.88 ) 10.0 ( 2.50 ) 10.2 ( 3.05 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cenerimod 0.5 mg
    Reporting group description
    		 Subjects received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Cenerimod 1 mg
    Reporting group description
    		 Subjects received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Cenerimod 2 mg
    Reporting group description
    		 Subjects received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Cenerimod 4 mg
    Reporting group description
    		 Subjects received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo once daily in addition to background SLE therapy for up to to 6 months.
    Reporting group title
    Cenerimod 0.5 mg
    Reporting group description
    		 Subjects completing treatment period 1 continued to receive cenerimod 0.5 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Cenerimod 1 mg
    Reporting group description
    		 Subjects completing treatment period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Cenerimod 2 mg
    Reporting group description
    		 Subjects completing treatment period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Cenerimod 2 mg (Ex 4 mg)
    Reporting group description
    		 Half the subjects completing treatment with cenerimod 4 mg in treatment period 1 were re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during treatment period 2. Subjects received cenerimod 2 mg for up to 6 months.

    Reporting group title
    Placebo (Ex 4 mg)
    Reporting group description
    		 Half the subjects completing treatment with cenerimod 4 mg in treatment period 1 were re-randomized to placebo once daily in addition to background SLE therapy during treatment period 2. Subjects received placebo for up to 6 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects completing treatment period 1 continued to receive placebo once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Primary: Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score

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    End point title
    		 Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
    End point description
    The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a weighted, cumulative index of lupus disease activity scored by the physician and is calculated from 24 individual descriptors and measures disease activity within the last 10 days. In this study the SLEDAI-2K was modified, to exclude leucopenia, due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change indicates an improvement in systemic lupus erythematosus disease activity from baseline to month 6.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Month 6.
    End point values
    		 Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Placebo
    Number of subjects analysed
    85
    85
    86
    85
    86
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -3.24 (-3.98 to -2.49)
    -3.41 (-4.16 to -2.67)
    -2.84 (-3.58 to -2.09)
    -4.04 (-4.79 to -3.28)
    -2.85 (-3.60 to -2.10)
    Statistical analysis title
    		 mSLEDAI analysis: TP1 cenerimod 0.5 mg and placebo
    Statistical analysis description
    The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.
    Comparison groups
    Cenerimod 0.5 mg v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4749
    Method
    		 Mixed models analysis
    Parameter type
    		 LS mean difference to placebo
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 0.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54
    Statistical analysis title
    		 mSLEDAI analysis: TP1 cenerimod 1 mg and placebo
    Comparison groups
    Cenerimod 1 mg v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2941
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference to placebo
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.62
         upper limit
    		 0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54
    Statistical analysis title
    		 mSLEDAI analysis: TP1 cenerimod 2 mg and placebo
    Comparison groups
    Cenerimod 2 mg v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9802
    Method
    		 Mixed models analysis
    Parameter type
    		 LS mean difference to placebo
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 1.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54
    Statistical analysis title
    		 mSLEDAI analysis: TP1 cenerimod 4 mg and placebo
    Comparison groups
    Cenerimod 4 mg v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0291
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference to placebo
    Point estimate
    -1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.25
         upper limit
    		 -0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54

    Secondary: Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline

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    End point title
    		 Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
    End point description
    A responder could only be assessed if the full information of all body systems was available. A participant was defined as a responder based on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) was a composite, binary endpoint based on three variables: • mSLEDAI-2K score had to have a reduction from baseline greater than or equal to 4, • Physician Global Assessment (PGA) had to have an increase from baseline less than or equal to 0.3. The PGA is a 100 mm visual analog scale used by the physician to assess disease activity ranging for 0 to 3. The scale is anchored with values from 0 = "none" and 3 = "severe"), and • BILAG-2004 (no new BILAG A organ domain score and at most one new BILAG B organ domain score) compared with baseline. If one of the SRI-4 mSLEDAI-2K, PGA and BILAG variables were not met the subject was scored a non-responder. Subjects that did not fit at least one of the above criteria were assigned to the missing group.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Month 6
    End point values
    		 Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Placebo
    Number of subjects analysed
    85
    85
    86
    85
    86
    Units: number of subjects
        Responder
    36
    41
    38
    41
    34
        Non-responder
    45
    38
    41
    36
    43
        Missing
    4
    6
    7
    8
    9
    Statistical analysis title
    		 SRI-4 analysis: TP1 cenerimod 0.5 mg and placebo
    Statistical analysis description
    A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose and mSLEDAI-2K) as fixed effects and subject as random effect.
    Comparison groups
    Cenerimod 0.5 mg v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.974
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.9
    Statistical analysis title
    		 SRI-4 analysis: TP1 cenerimod 1 mg and placebo
    Statistical analysis description
    A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose and mSLEDAI-2K) as fixed effects and subject as random effect..
    Comparison groups
    Cenerimod 1 mg v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2845
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.65
    Statistical analysis title
    		 SRI-4 analysis: TP1 cenerimod 2 mg and placebo
    Statistical analysis description
    A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose and mSLEDAI-2K) as fixed effects and subject as random effect.
    Comparison groups
    Cenerimod 2 mg v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5115
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 2.32
    Statistical analysis title
    		 SRI-4 analysis: TP1 cenerimod 4 mg and placebo
    Statistical analysis description
    A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose and mSLEDAI-2K) as fixed effects and subject as random effect.
    Comparison groups
    Cenerimod 4 mg v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2408
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 2.76

    Secondary: British Isles Lupus Assessment Group-2004 (BILAG) disease activity index response at Month 6

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    End point title
    		 British Isles Lupus Assessment Group-2004 (BILAG) disease activity index response at Month 6
    End point description
    The British Isles Lupus Assessment Group-2004 (BILAG) is a comprehensive tool used by the physician to assess disease activity and is sensitive to small changes over time. Response (no worsening) at Month 6 on BILAG-2004 disease activity index was defined as no new BILAG A organ domain score and no more than one new BILAG B organ domain score compared with baseline. No analysis is reported because the model did not meet the convergence criteria.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Month 6
    End point values
    		 Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Placebo
    Number of subjects analysed
    81
    79
    79
    77
    77
    Units: Percentage of subjects
        number (not applicable)
    98.8
    98.7
    97.5
    98.7
    97.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 18 months after first intake of medication after randomization. Adverse Events (AEs) were defined as those AEs with onset on or after the first day, treatment-emergent, to the last day of double-blind study treatment intake plus 6 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Cenerimod 0.5 mg
    Reporting group description
    		 Subjects received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1. Subjects completing treatment period 1 continued with cenerimod 0.5 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Cenerimod 1 mg
    Reporting group description
    		 Subjects received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1. Subjects completing treatment period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Cenerimod 2 mg
    Reporting group description
    		 Subjects received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1. Subjects completing treatment period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo once daily in addition to background SLE therapy for up to 6 months in treatment period 1. Subjects completing treatment period 1 continued with placebo once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months.

    Reporting group title
    Placebo / Ex-4 mg
    Reporting group description
    		 Subjects received placebo once daily in addition to background SLE therapy for up to 6 months in treatment period 2. (These participants previously received cenerimod 4 mg once daily in addition to background SLE therapy for 6 months in treatment period 1).

    Reporting group title
    Not re-randomized / Ex-4 mg
    Reporting group description
    		 Subjects were not re-randomized and did not receive treatment in treatment period 2. (These subjects previously received cenerimod 4 mg once daily in addition to background SLE therapy for 6 months in treatment period 1).

    Reporting group title
    Cenerimod 2 mg / Ex-4 mg
    Reporting group description
    		 Subjects received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 2. (These subjects previously received cenerimod 4 mg once daily in addition to background SLE therapy for 6 months in treatment period 1).

    Serious adverse events
    		 Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Placebo Placebo / Ex-4 mg Not re-randomized / Ex-4 mg Cenerimod 2 mg / Ex-4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 84 (4.76%)
    12 / 85 (14.12%)
    4 / 87 (4.60%)
    6 / 86 (6.98%)
    0 / 35 (0.00%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
         number of deaths (all causes)
    0
    2
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    2
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal perforation
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic mass
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Systemic lupus erythematosus rash
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cutaneous vasculitis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral toxoplasmosis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Placebo Placebo / Ex-4 mg Not re-randomized / Ex-4 mg Cenerimod 2 mg / Ex-4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 84 (44.05%)
    54 / 85 (63.53%)
    53 / 87 (60.92%)
    39 / 86 (45.35%)
    20 / 35 (57.14%)
    13 / 14 (92.86%)
    23 / 35 (65.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 84 (2.38%)
    8 / 85 (9.41%)
    3 / 87 (3.45%)
    2 / 86 (2.33%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    8 / 35 (22.86%)
         occurrences all number
    2
    8
    3
    2
    0
    0
    10
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 84 (1.19%)
    3 / 85 (3.53%)
    2 / 87 (2.30%)
    0 / 86 (0.00%)
    1 / 35 (2.86%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    1
    3
    2
    0
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Catarrh
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    2 / 86 (2.33%)
    1 / 35 (2.86%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    2
    1
    1
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Forced expiratory volume decreased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    1 / 87 (1.15%)
    2 / 86 (2.33%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    2
    0
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 84 (1.19%)
    5 / 85 (5.88%)
    3 / 87 (3.45%)
    0 / 86 (0.00%)
    1 / 35 (2.86%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    7
    3
    0
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    5 / 87 (5.75%)
    0 / 86 (0.00%)
    1 / 35 (2.86%)
    2 / 14 (14.29%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    5
    0
    2
    2
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Bone contusion
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Ankle fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    2 / 87 (2.30%)
    1 / 86 (1.16%)
    1 / 35 (2.86%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    3
    2
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 84 (13.10%)
    12 / 85 (14.12%)
    8 / 87 (9.20%)
    4 / 86 (4.65%)
    2 / 35 (5.71%)
    1 / 14 (7.14%)
    8 / 35 (22.86%)
         occurrences all number
    12
    13
    9
    5
    2
    1
    10
    Somnolence
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 84 (2.38%)
    4 / 85 (4.71%)
    1 / 87 (1.15%)
    1 / 86 (1.16%)
    2 / 35 (5.71%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    2
    7
    1
    1
    4
    0
    1
    Lymphopenia
         subjects affected / exposed
    4 / 84 (4.76%)
    10 / 85 (11.76%)
    12 / 87 (13.79%)
    1 / 86 (1.16%)
    4 / 35 (11.43%)
    5 / 14 (35.71%)
    7 / 35 (20.00%)
         occurrences all number
    4
    12
    18
    1
    4
    7
    12
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Dry eye
         subjects affected / exposed
    3 / 84 (3.57%)
    2 / 85 (2.35%)
    9 / 87 (10.34%)
    3 / 86 (3.49%)
    2 / 35 (5.71%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    2
    9
    3
    2
    0
    0
    Cataract subcapsular
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    Vision blurred
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Eye pain
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    Gastrointestinal disorders
    Acid peptic disease
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 84 (1.19%)
    6 / 85 (7.06%)
    0 / 87 (0.00%)
    2 / 86 (2.33%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    2 / 35 (5.71%)
         occurrences all number
    1
    6
    0
    2
    0
    1
    2
    Abdominal distension
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    4 / 84 (4.76%)
    4 / 85 (4.71%)
    3 / 87 (3.45%)
    3 / 86 (3.49%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    3 / 35 (8.57%)
         occurrences all number
    6
    6
    4
    4
    0
    0
    4
    Dyspepsia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
    1 / 87 (1.15%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    1
    4
    1
    1
    0
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    Nausea
         subjects affected / exposed
    3 / 84 (3.57%)
    1 / 85 (1.18%)
    1 / 87 (1.15%)
    2 / 86 (2.33%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
         occurrences all number
    3
    3
    1
    2
    0
    1
    2
    Vomiting
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
    1 / 87 (1.15%)
    1 / 86 (1.16%)
    1 / 35 (2.86%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    1
    1
    1
    1
    1
    Skin and subcutaneous tissue disorders
    Macule
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Brachioradial pruritus
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    2
    Muscle spasms
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 84 (0.00%)
    3 / 85 (3.53%)
    1 / 87 (1.15%)
    2 / 86 (2.33%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    4
    1
    2
    0
    0
    2
    Osteitis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 84 (0.00%)
    5 / 85 (5.88%)
    1 / 87 (1.15%)
    4 / 86 (4.65%)
    2 / 35 (5.71%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    5
    1
    8
    2
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 84 (9.52%)
    8 / 85 (9.41%)
    10 / 87 (11.49%)
    11 / 86 (12.79%)
    2 / 35 (5.71%)
    2 / 14 (14.29%)
    1 / 35 (2.86%)
         occurrences all number
    8
    9
    10
    11
    2
    2
    1
    Cellulitis
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    2 / 35 (5.71%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    Eyelid infection
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 84 (5.95%)
    0 / 85 (0.00%)
    6 / 87 (6.90%)
    5 / 86 (5.81%)
    1 / 35 (2.86%)
    1 / 14 (7.14%)
    3 / 35 (8.57%)
         occurrences all number
    5
    0
    6
    5
    1
    1
    3
    Ophthalmic herpes simplex
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Oral herpes
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    5
    Pharyngitis
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
    5 / 87 (5.75%)
    2 / 86 (2.33%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    5
    5
    2
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 35 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
    2 / 87 (2.30%)
    9 / 86 (10.47%)
    0 / 35 (0.00%)
    1 / 14 (7.14%)
    4 / 35 (11.43%)
         occurrences all number
    2
    2
    2
    9
    0
    1
    4
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 84 (8.33%)
    4 / 85 (4.71%)
    5 / 87 (5.75%)
    1 / 86 (1.16%)
    2 / 35 (5.71%)
    1 / 14 (7.14%)
    4 / 35 (11.43%)
         occurrences all number
    8
    5
    5
    1
    2
    1
    4
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
    3 / 87 (3.45%)
    0 / 86 (0.00%)
    2 / 35 (5.71%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    3
    0
    2
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
    4 / 87 (4.60%)
    1 / 86 (1.16%)
    2 / 35 (5.71%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    6
    1
    2
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Sep 2019
    Protocol amendment dated 31 July 2019. Addition of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue questionnaire. Inclusion of anchor patient global assessment questions for FACIT - questionnaire and other questionnaires to inform definition of responders and clinical meaningfulness of difference between groups.
    27 Mar 2020
    Protocol amendment dated 3 March 2020. Revision of specific stopping criteria and discharge criteria on Day 1. Introduction of the re-screening procedure for subjects who failed screening due to a transient non-eligibility reason.
    11 Jan 2021
    Protocol amendment dated 2 December 2020. Adjustment in sample size due to the slower than anticipated enrollment and unpredictable future impact of the COVID-19 pandemic. Study treatment was extended to 12 months for all randomized subjects. All subjects who completed Treatment Period 1 entered Treatment Period 2 for an additional 6 months.

    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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