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    Clinical Trial Results:
    A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease

    Summary
    EudraCT number
    		 2020-004937-19
    Trial protocol
    		 DE   ES   HU  
    Global end of trial date
    07 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2024
    First version publication date
    01 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CMHV370A12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04988087
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of the trial were: • To evaluate the efficacy of MHV370 compared to placebo based on change from baseline in ESSDAI [EULAR (European League against Rheumatism) Sjogren’s Syndrome Disease Activity Index] in SjS (Sjogren´s Syndrome) participants • To evaluate the efficacy of MHV370 compared to placebo based on change from baseline in Physician Global Assessment (PhGA) in MCTD (Mixed Connective Tissue Disease) participants.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 2
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Poland: 9
    Worldwide total number of subjects
    30
    EEA total number of subjects
    24
    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)
    28
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 10 investigative sites in 6 countries/regions.

    Pre-assignment
    Screening details
    		 There was a screening period of up to 6 weeks to assess participants eligibility.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MHV370 200mg - SjS
    Arm description
    		 MHV370 200mg oral dose, twice daily. SjS participants.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MHV370
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MHV370 200 mg oral twice daily - SjS participants

    Arm title
    		 Placebo - SjS
    Arm description
    		 Placebo oral dose, twice daily. SjS participants.
    Arm type
    		 Placebo

    Investigational medicinal product name
    MHV370
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral twice daily - SjS participants

    Arm title
    		 MHV370 200mg - MCTD
    Arm description
    		 MHV370 200mg oral dose, twice daily. MCTD participants.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MHV370
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MHV370 200 mg oral twice daily - MCTD participants

    Arm title
    		 Placebo - MCTD
    Arm description
    		 Placebo oral dose, twice daily. MCTD participants.
    Arm type
    		 Placebo

    Investigational medicinal product name
    MHV370
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral twice daily - MCTD participants

    Number of subjects in period 1
    		MHV370 200mg - SjS Placebo - SjS MHV370 200mg - MCTD Placebo - MCTD
    Started
    12
    14
    2
    2
    Completed
    0
    4
    1
    0
    Not completed
    12
    10
    1
    2
         Consent withdrawn by subject
    1
    1
    -
    -
         Adverse events
    4
    -
    -
    -
         Technical problems
    7
    9
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MHV370 200mg - SjS
    Reporting group description
    		 MHV370 200mg oral dose, twice daily. SjS participants.

    Reporting group title
    Placebo - SjS
    Reporting group description
    		 Placebo oral dose, twice daily. SjS participants.

    Reporting group title
    MHV370 200mg - MCTD
    Reporting group description
    		 MHV370 200mg oral dose, twice daily. MCTD participants.

    Reporting group title
    Placebo - MCTD
    Reporting group description
    		 Placebo oral dose, twice daily. MCTD participants.

    Reporting group values
    		 MHV370 200mg - SjS Placebo - SjS MHV370 200mg - MCTD Placebo - MCTD Total
    Number of subjects
    		 12 14 2 2 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 11 13 2 2 28
        From 65-84 years
    		 1 1 0 0 2
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.3 ( 12.20 ) 54.7 ( 9.67 ) 35.0 ( 12.73 ) 44.0 ( 0.00 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 12 14 2 2 30
        Male
    		 0 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 3 3 0 0 6
        White
    		 9 11 2 2 24

    End points

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    End points reporting groups
    Reporting group title
    MHV370 200mg - SjS
    Reporting group description
    		 MHV370 200mg oral dose, twice daily. SjS participants.

    Reporting group title
    Placebo - SjS
    Reporting group description
    		 Placebo oral dose, twice daily. SjS participants.

    Reporting group title
    MHV370 200mg - MCTD
    Reporting group description
    		 MHV370 200mg oral dose, twice daily. MCTD participants.

    Reporting group title
    Placebo - MCTD
    Reporting group description
    		 Placebo oral dose, twice daily. MCTD participants.

    Primary: SjS participants: Change from baseline in Eular Sjögren's Disease Activity Index (ESSDAI) after 24 weeks of treatment

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    End point title
    		 SjS participants: Change from baseline in Eular Sjögren's Disease Activity Index (ESSDAI) after 24 weeks of treatment [1] [2]
    End point description
    The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Endpoint specific to and only reported for SjS participants
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for SjS participants
    End point values
    		 MHV370 200mg - SjS Placebo - SjS
    Number of subjects analysed
    0 [3]
    4
    Units: Score on scale
        arithmetic mean (standard error)
    ( )
    -4.39 ( 2.41 )
    Notes
    [3] - The insufficient sampling scheme did not allow to provide the data.
    No statistical analyses for this end point

    Primary: MCTD participants: Change from baseline in physician’s global assessment scale (PhGA) after 24 weeks of treatment

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    End point title
    		 MCTD participants: Change from baseline in physician’s global assessment scale (PhGA) after 24 weeks of treatment [4] [5]
    End point description
    The physician’s global assessment scale is used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from “no disease activity” (0) to “maximal disease activity” (100). A negative change score from baseline indicates improvement. Only participants with evaluable records are included.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Endpoint specific to and only reported for MCTD participants
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    1
    0 [6]
    Units: Score on scale
        median (full range (min-max))
    -62.00 (-62.00 to -62.00)
    ( to )
    Notes
    [6] - The insufficient sampling scheme did not allow to provide the data.
    No statistical analyses for this end point

    Secondary: SjS and MCTD participants: Maximum observed plasma concentrations (Cmax) of MHV370 at steady state

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    End point title
    		 SjS and MCTD participants: Maximum observed plasma concentrations (Cmax) of MHV370 at steady state [7]
    End point description
    Cmax is the maximum (peak) observed plasma concentration of MHV370 after single dose administration. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. Cmax was determined using non-compartmental methods. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK Endpoint not analyzed for participants on placebo
    End point values
    		 MHV370 200mg - SjS MHV370 200mg - MCTD
    Number of subjects analysed
    8
    1
    Units: ng/mL
        arithmetic mean (standard deviation)
    278 ( 85.7 )
    194 ( 999 )
    No statistical analyses for this end point

    Secondary: SjS and MCTD participants: Area under the plasma concentration-time curve from time zero to 6 hours (AUC0-6h) of MHV370

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    End point title
    		 SjS and MCTD participants: Area under the plasma concentration-time curve from time zero to 6 hours (AUC0-6h) of MHV370 [8]
    End point description
    The AUC from time zero to the 6-hours post-dose sampling time. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. AUClast was determined using non-compartmental methods. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK Endpoint not analyzed for participants on placebo
    End point values
    		 MHV370 200mg - SjS MHV370 200mg - MCTD
    Number of subjects analysed
    5
    1
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    1060 ( 462 )
    742 ( 999 )
    No statistical analyses for this end point

    Secondary: SjS and MCTD participants: Time to reach maximum plasma concentrations (Tmax) of MHV370 at steady state

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    End point title
    		 SjS and MCTD participants: Time to reach maximum plasma concentrations (Tmax) of MHV370 at steady state [9]
    End point description
    Tmax is the time to reach maximum (peak) plasma concentration of MHV370 after single dose administration. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. Tmax was determined using non-compartmental methods. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK Endpoint not analyzed for participants on placebo
    End point values
    		 MHV370 200mg - SjS MHV370 200mg - MCTD
    Number of subjects analysed
    8
    1
    Units: hours
        median (full range (min-max))
    1.50 (1.00 to 4.00)
    2.00 (000 to 999)
    No statistical analyses for this end point

    Secondary: SjS and MCTD participants: Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale

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    End point title
    		 SjS and MCTD participants: Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale
    End point description
    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F v4) is a short, 13-item patient-reported measure, easy-to-administer tool that measures an individual’s level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where a higher FACIT-F score indicates more severe symptoms. A negative change score from baseline indicates improvement. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 20 and 24
    End point values
    		 MHV370 200mg - SjS Placebo - SjS MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    8
    12
    2
    1
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4
    0.13 ( 3.271 )
    -1.58 ( 6.052 )
    15.50 ( 9.192 )
    -3.00 ( 999 )
        Week 8 (n= 7,10,2,1)
    3.14 ( 5.928 )
    -2.80 ( 4.185 )
    20.00 ( 7.071 )
    -2.00 ( 999 )
        Week 12 (n= 4,7,1,0)
    -1.25 ( 6.702 )
    2.71 ( 8.826 )
    20.00 ( 999 )
    999 ( 999 )
        Week 20 (n= 1,5,1,0)
    -9.42 ( 999 )
    4.80 ( 8.758 )
    23.00 ( 999 )
    999 ( 999 )
        Week 24 (n= 0,4,1,0)
    999 ( 999 )
    5.75 ( 10.782 )
    30.00 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: SjS and MCTD participants: Change from baseline in Physician Global Assessment (PhGA)

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    End point title
    		 SjS and MCTD participants: Change from baseline in Physician Global Assessment (PhGA)
    End point description
    The physician’s global assessment scale is used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from “no disease activity” (0) to “maximal disease activity” (100). A negative change score from baseline indicates improvement. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 20 and 24
    End point values
    		 MHV370 200mg - SjS Placebo - SjS MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    8
    12
    2
    1
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4
    -1.75 ( 12.658 )
    -5.25 ( 11.185 )
    -20.50 ( 12.021 )
    -15.00 ( 999 )
        Week 8 (n= 7,10,2,1)
    2.57 ( 12.608 )
    -8.90 ( 11.474 )
    -39.00 ( 18.385 )
    -12.50 ( 999 )
        Week 12 (n= 4,7,1,0)
    -4.00 ( 20.559 )
    -19.43 ( 14.328 )
    -66.00 ( 999 )
    999 ( 999 )
        Week 20 (n= 1,5,1,0)
    3.00 ( 999 )
    -14.60 ( 22.423 )
    -64.00 ( 999 )
    999 ( 999 )
        Week 24 (n= 0,4,1,0)
    999 ( 999 )
    -30.75 ( 19.534 )
    -62.00 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: SjS participants: Change from baseline in Eular Sjögren’s Syndrome Disease Activity Index (ESSDAI)

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    End point title
    		 SjS participants: Change from baseline in Eular Sjögren’s Syndrome Disease Activity Index (ESSDAI) [10]
    End point description
    The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 20 and 24
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for SjS participants
    End point values
    		 MHV370 200mg - SjS Placebo - SjS
    Number of subjects analysed
    8
    12
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4
    -0.25 ( 1.753 )
    -3.67 ( 9.355 )
        Week 8 (n= 7,10)
    0.57 ( 6.528 )
    -4.80 ( 11.487 )
        Week 12 (n= 3,7)
    -3.00 ( 4.583 )
    -3.43 ( 7.656 )
        Week 20 (n= 1,5)
    -2.00 ( 999 )
    0.00 ( 14.629 )
        Week 24 (n= 0,4)
    999 ( 999 )
    -0.25 ( 11.117 )
    No statistical analyses for this end point

    Secondary: SjS participants: Change from baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI)

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    End point title
    		 SjS participants: Change from baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) [11]
    End point description
    The ESSPRI is a disease outcome measure for Sjögren's syndrome. The ESSPRI is a patient-reported, subjective symptom index which consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). The participant can assess severity of symptoms they experience on a single numerical scale of 0-10 (0=no symptom at all and 10= worst symptom imaginable) for each of the three domains. The overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Min. score can be 0 and max. score can be 10, where a higher score indicates severe symptoms. A negative change score from baseline indicates improvement. Due to system limitations, data fields in the table cannot contain letters. Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 4, 8, 12, 20 and 24
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for SjS participants
    End point values
    		 MHV370 200mg - SjS Placebo - SjS
    Number of subjects analysed
    8
    12
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4
    -0.12 ( 0.354 )
    -0.53 ( 1.105 )
        Week 8 (n= 7,10)
    -0.67 ( 0.793 )
    -0.37 ( 1.511 )
        Week 12 (n= 4,7)
    -0.42 ( 0.500 )
    -1.38 ( 1.976 )
        Week 20 (n= 1,5)
    -0.17 ( 999 )
    -2.20 ( 1.865 )
        Week 24 (n= 0,4)
    999 ( 999 )
    -2.00 ( 2.000 )
    No statistical analyses for this end point

    Secondary: SjS participants: Change from baseline to the salivary flow rate

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    End point title
    		 SjS participants: Change from baseline to the salivary flow rate [12]
    End point description
    Unstimulated whole salivary fluid secretions were collected over 5 minutes from participants. All assessments were performed at a fixed time of the day to minimize fluctuations related to the circadian rhythm of salivary flow and composition. Participants were instructed not to eat, drink or smoke for 90 minutes before the assessment. The start time and end time of saliva collection were recorded to calculate the salivary flow rate per minute. Only participants with evaluable records are included. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 12 and 24
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for SjS participants
    End point values
    		 MHV370 200mg - SjS Placebo - SjS
    Number of subjects analysed
    12
    14
    Units: mL/min
    arithmetic mean (standard deviation)
        Week 4
    0.162 ( 0.2735 )
    -0.127 ( 0.7914 )
        Week 12 (n= 4,7)
    0.144 ( 0.2109 )
    0.183 ( 0.3944 )
        Week 24 (n= 0,4)
    999 ( 999 )
    0.564 ( 0.9193 )
    No statistical analyses for this end point

    Secondary: SjS participants: Change from baseline to the Schirmer’s test

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    End point title
    		 SjS participants: Change from baseline to the Schirmer’s test [13]
    End point description
    Schirmer’s test is used to determine whether the eye produces enough tears to keep it moist especially for those who suffer from dry eye syndrome. A strip is placed in the lower eyelid for 5 minutes to assess tear production. After 5 minutes, the filter paper is removed and the distance between the leading edge of wetness and the initial fold is measured, using a millimeter ruler. Tear deficiency is defined as <5 mm wetting of the paper after 5 minutes. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 12 and 24
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for SjS participants
    End point values
    		 MHV370 200mg - SjS Placebo - SjS
    Number of subjects analysed
    12
    14
    Units: milimeter
    arithmetic mean (standard deviation)
        Week 4, right eye (n= 8,12)
    -1.5 ( 4.87 )
    0.0 ( 3.59 )
        Week 12, right eye (n= 4,7)
    -1.0 ( 2.16 )
    5.3 ( 8.81 )
        Week 24, right eye (n= 0,4)
    999 ( 999 )
    -3.0 ( 6.32 )
        Week 4, left eye (n= 8,12)
    1.1 ( 1.96 )
    1.6 ( 6.01 )
        Week 12, left eye (n= 4,7)
    2.0 ( 1.83 )
    4.9 ( 12.50 )
        Week 24, left eye (n= 0,4)
    999 ( 999 )
    -1.0 ( 2.94 )
    No statistical analyses for this end point

    Secondary: SjS participants: Sjögren’s Tool for Assessing Response (STAR) response over time up to week 24

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    End point title
    		 SjS participants: Sjögren’s Tool for Assessing Response (STAR) response over time up to week 24 [14]
    End point description
    STAR is a composite responder index, including in a single tool all main disease features, and designed for use as a key efficacy endpoint in SjS Domain Point Definition of response. Points are assigned in the following 5 domains, if the corresponding criteria are met: • Systemic activity, if decrease in clin ESSDAI ≥ 3 points: 3 points • Patient reported outcome, if decrease in ESSPRI ≥ 1 point or 15%: 3 points • Lacrimal gland function (assessed by Schirmer’s test), if abnormal score at baseline: increase ≥ 5 mm from baseline OR if normal score at baseline: no change to abnormal: 1 point • Salivary gland function (assessed by unstimulated salivary flow), if increase ≥ 25% from baseline: 1 point • Biological (assessed by serum IgG levels), if decrease ≥ 10%: 1 point The Total Score is the sum of all 5 domain scores, ranging from 0 to 9 points. A STAR responder is defined as ≥ 5 points in the Total Score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 12 and 24
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for SjS participants
    End point values
    		 MHV370 200mg - SjS Placebo - SjS
    Number of subjects analysed
    12
    14
    Units: participants
        Week 4
    0
    3
        Week 12
    1
    4
        Week 24
    0
    2
    No statistical analyses for this end point

    Secondary: MCTD: Change from baseline in articular and pulmonary domains of the Eular Sjögren’s Syndrome Disease Activity Index (ESSDAI)

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    End point title
    		 MCTD: Change from baseline in articular and pulmonary domains of the Eular Sjögren’s Syndrome Disease Activity Index (ESSDAI) [15]
    End point description
    The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. Participants with Mixed Connective Tissue Disease (MCTD) completed the articular (from 0 “no activity” to 3 “high activity”) and pulmonary (from 0 “no activity to 3 “high activity”) domains of the ESSDAI only. For MCTD participants, the score range is 0-21, where a higher score indicates more severe symptoms. A negative change score from baseline indicates improvement. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12 and 24
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    2
    1
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4 - articular
    0.00 ( 0.000 )
    0.00 ( 999 )
        Week 8 - articular
    -1.00 ( 0.000 )
    0.00 ( 999 )
        Week 12 - articular (n= 1,0)
    -1.00 ( 999 )
    999 ( 999 )
        Week 24 - articular (n= 1,0)
    -2.00 ( 999 )
    999 ( 999 )
        Week 4 - pulmonary
    0.00 ( 0.000 )
    0.00 ( 999 )
        Week 8 - pulmonary
    -0.50 ( 0.707 )
    0.00 ( 999 )
        Week 12 - pulmonary (n= 1,0)
    -1.00 ( 999 )
    999 ( 999 )
        Week 24 - pulmonary (n= 1,0)
    -1.00 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: MCTD participants: Change from baseline in Forced expiratory volume during the first second (FEV1) of a forced breath

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    End point title
    		 MCTD participants: Change from baseline in Forced expiratory volume during the first second (FEV1) of a forced breath [16]
    End point description
    FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 is considered a favourable outcome. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    1
    0 [17]
    Units: liters (L)
        arithmetic mean (standard deviation)
    0.250 ( 999 )
    ( )
    Notes
    [17] - The insufficient sampling scheme did not allow to provide the data.
    No statistical analyses for this end point

    Secondary: MCTD participants: Change from baseline in Forced Vital Capacity (FVC)

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    End point title
    		 MCTD participants: Change from baseline in Forced Vital Capacity (FVC) [18]
    End point description
    Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    1
    0 [19]
    Units: liters (L)
        arithmetic mean (standard deviation)
    0.530 ( 999 )
    ( )
    Notes
    [19] - The insufficient sampling scheme did not allow to provide the data.
    No statistical analyses for this end point

    Secondary: MCTD participants: Change from baseline in Forced expiratory volume during the first two seconds (FEV2) of a forced breath

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    End point title
    		 MCTD participants: Change from baseline in Forced expiratory volume during the first two seconds (FEV2) of a forced breath [20]
    End point description
    FEV2 (forced expiratory volume in two seconds) is the amount of air which can be forcibly exhaled from the lungs in the first two seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV2 is considered a favourable outcome. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    1
    0 [21]
    Units: liters (L)
        arithmetic mean (standard deviation)
    0.410 ( 999 )
    ( )
    Notes
    [21] - The insufficient sampling scheme did not allow to provide the data.
    No statistical analyses for this end point

    Secondary: MCTD participants: Change from baseline in Forced expiratory volume during the first three seconds (FEV3) of a forced breath

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    End point title
    		 MCTD participants: Change from baseline in Forced expiratory volume during the first three seconds (FEV3) of a forced breath [22]
    End point description
    FEV3 (forced expiratory volume in three seconds) is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV3 is considered a favourable outcome. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    1
    0 [23]
    Units: liters (L)
        arithmetic mean (standard deviation)
    0.460 ( 999 )
    ( )
    Notes
    [23] - The insufficient sampling scheme did not allow to provide the data.
    No statistical analyses for this end point

    Secondary: MCTD participants: Diffusing capacity of the lungs for carbon monoxide (DLCO)

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    End point title
    		 MCTD participants: Diffusing capacity of the lungs for carbon monoxide (DLCO) [24]
    End point description
    Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure. The outcome is presented as percentage of predicted DLCO value. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    1
    2
    Units: percentage of predicted DLCO
    arithmetic mean (standard deviation)
        Baseline
    84.0 ( 999 )
    95.5 ( 2.12 )
        Week 24 (n= 0, 0)
    999 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: MCTD participants: Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD)

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    End point title
    		 MCTD participants: Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD) [25]
    End point description
    The K-BILD questionnaire is a self-administered health-status questionnaire that has been developed in patients with interstitial lung diseases. It consists of 15 items in three domains: breathlessness and activities, psychological factors, and chest symptoms. Total scores range from 0 to 100, with higher scores representing better health status. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12 and 24
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    2
    1
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4
    3.00 ( 4.243 )
    -2.00 ( 999 )
        Week 8
    13.00 ( 9.899 )
    0.00 ( 999 )
        Week 12 (n= 1,0)
    21.00 ( 999 )
    999 ( 999 )
        Week 24 (n= 1,0)
    58.00 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: MCTD participants: Change from baseline in Raynaud’s Condition Score (RCS)

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    End point title
    		 MCTD participants: Change from baseline in Raynaud’s Condition Score (RCS) [26]
    End point description
    The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon and impact of Raynaud's alone on use of hands every day. An 11-point Likert scale is used to rate the difficulty caused by the condition with 0 = no difficulty and 10 = extreme difficulty. Participants are asked to select the number that best describes their difficulty, with higher score indicating worse condition. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 12 and 24
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint specific to and only reported for MCTD participants
    End point values
    		 MHV370 200mg - MCTD Placebo - MCTD
    Number of subjects analysed
    2
    2
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4 (n= 2,1)
    -2.50 ( 3.536 )
    1.00 ( 999 )
        Week 12 (n= 1,0)
    -1.00 ( 999 )
    999 ( 999 )
        Week 24 (n= 1,0)
    -2.00 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    MHV370 200 mg b.i.d
    Reporting group description
    		 MHV370 200 mg b.i.d

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 MHV370 200 mg b.i.d Placebo Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MHV370 200 mg b.i.d Placebo Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 14 (92.86%)
    14 / 16 (87.50%)
    27 / 30 (90.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Vasculitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    0
    2
    General disorders and administration site conditions
    Feeling hot
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    2
    Malaise
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Asthenia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Swelling
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 16 (12.50%)
    5 / 30 (16.67%)
         occurrences all number
    3
    2
    5
    Cough
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Amylase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Antinuclear antibody increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Complement factor C3 decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    2
    Complement factor C4 decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Weight increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    0
    2
    Palpitations
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    2
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Neuralgia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Hypergeusia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    6 / 16 (37.50%)
    8 / 30 (26.67%)
         occurrences all number
    2
    8
    10
    Facial paralysis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    1
    3
    4
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    3
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Anaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Neutropenia
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    3
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Conjunctival suffusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Cataract
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Parotid gland enlargement
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Paraesthesia oral
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Mouth swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Duodenitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Dry mouth
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    3 / 30 (10.00%)
         occurrences all number
    2
    2
    4
    Dental caries
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    2
    Aphthous ulcer
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    2
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    2
    1
    3
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Cutaneous vasculitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Acne
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Vertebral foraminal stenosis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Back pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Arthralgia
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 16 (6.25%)
    3 / 30 (10.00%)
         occurrences all number
    2
    1
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 14 (28.57%)
    2 / 16 (12.50%)
    6 / 30 (20.00%)
         occurrences all number
    4
    2
    6
    Cystitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Dacryocanaliculitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Helicobacter infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Herpes zoster
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Otitis media
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Rash pustular
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 16 (6.25%)
    3 / 30 (10.00%)
         occurrences all number
    2
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    1
    1
    2
    Viral infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    2
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    3
    Hyperuricaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    1
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2021
    The reason for this amendment was to update the exclusion criteria and assessment schedule, changed ECG from local to central assessments, SAE reporting, and revised the protocol summary to reflect cardiovascular disease or ECG abnormalities (indicating significant safety risk for the participants) as key exclusion criterion.
    29 Sep 2021
    The reason for this amendment was to update the exclusion criteria, laboratory evaluations, discontinuation from study treatment criteria, and the study stopping rules.
    09 May 2022
    The reason for this amendment was to update the discontinuation criteria for those patients that test positive for SARS-CoV-2 based on emergent data. Also, added a secondary efficacy endpoint called ‘STAR’, and added an interim analysis planned after approximately 50% of SjS participants had completed 24 (and not 12) weeks of treatment to evaluate the efficacy of MHV370.

    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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