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    Clinical Trial Results:
    A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects with Systemic Sclerosis

    Summary
    EudraCT number
    		 2018-001817-33
    Trial protocol
    		 GB   DE   BE   IT  
    Global end of trial date
    22 Jun 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1690-CL-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03798366
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.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
    18 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of GLPG1690 as evaluated by modified Rodnan Skin Score (mRSS) compared to placebo over 24 weeks for the treatment of participants with systemic sclerosis
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the “Declaration of Helsinki” and its amendments in force at the time of the study (2013 version). It was also carried out in conformity with the protocol, the International Council for Harmonisation Guideline for Good Clinical Practice (ICH-GCP) E6 (R2), and local ethical and legal requirements. The investigator informed the subjects of the risks and benefits of the study. The subjects were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained a copy of the ICFs, which are available to the sponsor for inspection. The subjects were covered by the sponsor’s insurance according to local legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2019
    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
    Italy: 2
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 12
    Worldwide total number of subjects
    33
    EEA total number of subjects
    23
    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
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Belgium, the United States, United Kingdom, Spain, and Italy. The first participant was screened on 14 Jan 2019. The last study visit occurred on 22 Jun 2020.

    Pre-assignment
    Screening details
    		 A total of 40 participants were screened, of whom 33 participants were randomized and treated.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GLPG1690 600 mg
    Arm description
    		 Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1690
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Placebo
    Arm description
    		 Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
    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
    Placebo was administered per the schedule specified in the arm description.

    Number of subjects in period 1
    		GLPG1690 600 mg Placebo
    Started
    21
    12
    Completed
    21
    11
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    		 Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.

    Reporting group values
    		 GLPG1690 600 mg Placebo Total
    Number of subjects
    		 21 12 33
    Age categorical
    Units: Subjects
        Less than or equal to 45 years
    		 7 5 12
        Greater than 45 years
    		 14 7 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.4 ( 13.58 ) 47.3 ( 17.99 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 8 23
        Male
    		 6 4 10
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 2
        Not Hispanic or Latino
    		 20 10 30
        Unknown or Not Reported
    		 0 1 1
    Race
    Units: Subjects
        Asian
    		 0 1 1
        White
    		 21 11 32
    Modified Rodnan Skin Score (mRSS)
    The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 27.0 ( 8.84 ) 22.5 ( 6.24 ) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    		 Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.

    Primary: Change From Baseline in mRSS at Week 4

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    End point title
    		 Change From Baseline in mRSS at Week 4
    End point description
    The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of investiational product.
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    End point values
    		 GLPG1690 600 mg Placebo
    Number of subjects analysed
    21
    12
    Units: units on a scale
        least squares mean (standard error)
    -2.2 ( 0.85 )
    -1.6 ( 1.04 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. A negative difference indicates a greater improvement in the GLPG1690 treatment group.
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6757
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square (LS) mean difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.29

    Primary: Change From Baseline in mRSS at Week 8

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    End point title
    		 Change From Baseline in mRSS at Week 8
    End point description
    The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Participants in the FAS were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline, Week 8
    End point values
    		 GLPG1690 600 mg Placebo
    Number of subjects analysed
    21
    12
    Units: units on a scale
        least squares mean (standard error)
    -3.2 ( 0.85 )
    -2.5 ( 1.07 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. A negative difference indicates a greater improvement in the GLPG1690 treatment group.
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6079
    Method
    		 Mixed models analysis
    Parameter type
    		 LS mean difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.31

    Primary: Change From Baseline in mRSS at Week 16

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    End point title
    		 Change From Baseline in mRSS at Week 16
    End point description
    The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Participants in the FAS were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 GLPG1690 600 mg Placebo
    Number of subjects analysed
    21
    12
    Units: units on a scale
        least squares mean (standard error)
    -6.8 ( 0.85 )
    -4.8 ( 1.12 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. A negative difference indicates a greater improvement in the GLPG1690 treatment group.
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1298
    Method
    		 Mixed models analysis
    Parameter type
    		 LS mean difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.35

    Primary: Change From Baseline in mRSS at Week 24

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    End point title
    		 Change From Baseline in mRSS at Week 24
    End point description
    The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Participants in the FAS were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 GLPG1690 600 mg Placebo
    Number of subjects analysed
    21
    12
    Units: units on a scale
        least squares mean (standard error)
    -8.9 ( 0.87 )
    -6.0 ( 1.11 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. A negative difference indicates a greater improvement in the GLPG1690 treatment group.
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0411
    Method
    		 Mixed models analysis
    Parameter type
    		 LS mean difference
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.36

    Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline up to end of the study (36 weeks)
    End point values
    		 GLPG1690 600 mg Placebo
    Number of subjects analysed
    21
    12
    Units: participants
        TEAEs
    20
    11
        Serious TEAEs
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to end of the study (36 weeks)
    Adverse event reporting additional description
    Participants in the safety analysis set were analyzed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    		 Participants received GLPG1690 600 mg, orally once daily for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.

    Serious adverse events
    		 GLPG1690 600 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Foreign body in gastrointestinal tract
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GLPG1690 600 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 21 (95.24%)
    11 / 12 (91.67%)
    Vascular disorders
    Hot flush
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 12 (8.33%)
         occurrences all number
    3
    1
    Dyspnoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Interstitial lung disease
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Sinus congestion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anger
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Aspartate aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Weight increased
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Ligament sprain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Limb injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Tendon injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Vascular injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Bundle branch block left
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Palpitations
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 12 (8.33%)
         occurrences all number
    2
    1
    Nervous system disorders
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 12 (8.33%)
         occurrences all number
    3
    1
    Dyskinesia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 12 (16.67%)
         occurrences all number
    5
    3
    Memory impairment
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Migraine
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 21 (33.33%)
    2 / 12 (16.67%)
         occurrences all number
    7
    5
    Dyspepsia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Eructation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastric antral vascular ectasia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrointestinal inflammation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Gingival recession
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Acne
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Digital pitting scar
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Hair growth abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hyperhidrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Hypertrichosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Night sweats
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    Rash erythematous
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Rash macular
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Skin lesion
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Skin ulcer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 12 (8.33%)
         occurrences all number
    1
    2
    Renal and urinary disorders
    Pollakiuria
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Bone disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Fibromyalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Muscular weakness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Musculoskeletal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Osteolysis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Scleroderma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Synovitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Tenosynovitis stenosans
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Cellulitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Oral herpes
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Otitis media
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 12 (8.33%)
         occurrences all number
    2
    1
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Suspected COVID-19
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 12 (16.67%)
         occurrences all number
    2
    3
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dyslipidaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Lactose intolerance
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vitamin D deficiency
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2018
    The protocol was amended to revise the participant exclusion criteria.
    31 Jul 2019
    The protocol was amended to update the information based on Investigator Brochure Edition 6 (28 Jun 2019), for corrections of errors, and for revision of participant exclusion criteria.
    28 Apr 2020
    The protocol was amended to implement urgent safety measures (USM) to mitigate the impact of the coronavirus disease-2019 (COVID-19) pandemic for the systemic sclerosis participants.

    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.
    This was a proof-of-concept study not sized or powered to confirm any treatment effect.
    For support, Contact us.
    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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