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    Clinical Trial Results:
    A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

    Summary
    EudraCT number
    		 2015-005023-11
    Trial protocol
    		 GB   PL   ES   IT  
    Global end of trial date
    30 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2019
    First version publication date
    14 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EMR 200017-014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02745145
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck KGaA, Darmstadt, Germany
    Sponsor organisation address
    Frankfurter Strasse 250,, Darmstadt, Germany, 64293
    Public contact
    Communication Center, Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center, Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of subjects with SSc-ILD who already receive constant doses of mycophenolate.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    24
    EEA total number of subjects
    4
    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)
    19
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study enrolled 24 subjects and was early terminated due to the difficulties experienced in identifying subjects who meet the eligibility criteria of the trial.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Arm title
    		 Abituzumab 500 milligrams (mg)
    Arm description
    		 Subjects received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abituzumab 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Arm title
    		 Abituzumab 1500 mg
    Arm description
    		 Subjects received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abituzumab 1500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Number of subjects in period 1
    		Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Started
    10
    5
    9
    Completed
    0
    0
    0
    Not completed
    10
    5
    9
         Adverse event, serious fatal
    -
    1
    -
         Study Termination
    8
    3
    7
         Adverse event, non-fatal
    1
    -
    -
         Withdrew consent
    1
    1
    1
         Progressive disease
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group title
    Abituzumab 500 milligrams (mg)
    Reporting group description
    		 Subjects received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group title
    Abituzumab 1500 mg
    Reporting group description
    		 Subjects received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg Total
    Number of subjects
    		 10 5 9 24
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 51 ( 10.6 ) 60 ( 7.5 ) 55 ( 7.8 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 8 4 7 19
        Male
    		 2 1 2 5
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 10 5 9 24
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 3 4
        Not Hispanic or Latino
    		 9 5 6 20
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group title
    Abituzumab 500 milligrams (mg)
    Reporting group description
    		 Subjects received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group title
    Abituzumab 1500 mg
    Reporting group description
    		 Subjects received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Primary: Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52

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    End point title
    		 Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52 [1]
    End point description
    FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. Change from baseline in fvc at week 52 was reported. Modified intent-to-treat (mITT) population was defined as all randomized subjects who received at least 1 dose of study drug (including placebo). Here, "Number of Subjects Analyzed" signified subjects evaluable for the endpoint. Here, 99999 signified standard deviation was not estimable as there was only one subject evaluable for the arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    2
    0 [2]
    1
    Units: milliliters
        arithmetic mean (standard deviation)
    -130 ( 56.6 )
    ( )
    -50 ( 99999 )
    Notes
    [2] - All subjects for abituzumab 500 mg arm dropped out before the analysis was conducted.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52

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    End point title
    		 Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52
    End point description
    Mahler's TDI is an interview-administered instrument that allows subjects to assess their level of dyspnea which is assessed by functional impairment, magnitude of task and magnitude of effort. Scores for each subscale range from -3 to +3 so that the TDI focal score ranges from -9 (major deterioration) to +9 (major improvement). For all subscale scores and the TDI focal score a higher value indicates a better outcome.mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo). Here,"number of subjects analyzed" signified subjects evaluable for the endpoint. Here, 99999 signified standard deviation was not estimable as there was only one subject evaluable for the arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    1
    0 [3]
    1
    Units: Score on a scale
        arithmetic mean (standard deviation)
    3 ( 99999 )
    ( )
    4 ( 99999 )
    Notes
    [3] - All subjects for abituzumab 500 mg arm dropped out before the analysis was conducted.
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52

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    End point title
    		 Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52
    End point description
    The SGRQ assesses health-related quality of life in subjects with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the weighted sum of domain scores for symptoms, activity, and impact (0=the best possible score and 100=the worst possible score). A reduction in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo). Here, "number of subjects analyzed" signified number of subjects evaluable for the endpoint. Here, 99999 signified standard deviation was not estimable as there was only one subject evaluable for the arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    1
    0 [4]
    1
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    6.4 ( 99999 )
    ( )
    1.4 ( 99999 )
    Notes
    [4] - All subjects for abituzumab 500 mg arm dropped out before the analysis was conducted.
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Subjects with Diffuse Cutaneous Skin Involvement at Baseline

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    End point title
    		 Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Subjects with Diffuse Cutaneous Skin Involvement at Baseline
    End point description
    mRSS measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease. mITT diffuse cutaneous systemic sclerosis population from mITT analysis set who had diffuse cutaneous skin involvement at baseline. Here, "number of subjects analyzed" signified number of subjects evaluable for the endpoint. Here, 99999 signified standard deviation was not estimable as there was only one subject evaluable for the arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    1
    0 [5]
    0 [6]
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    0 ( 99999 )
    ( )
    ( )
    Notes
    [5] - All subjects for abituzumab 500 mg arm dropped out before the analysis was conducted.
    [6] - All subjects for abituzumab 1500 mg arm dropped out before the analysis was conducted.
    No statistical analyses for this end point

    Secondary: Absolute Change from Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52

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    End point title
    		 Absolute Change from Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52
    End point description
    Absolute change from baseline in QLF score at week 52 was calculated as the difference of the QLF score at week 52 minus the QLF score at baseline divided in the region of highest baseline severity at Week 52 .The QLF score itself ranges from 0 to 100, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo). Here, "number of subjects analyzed" signified number of subjects evaluable for the endpoint. Here, 99999 signified standard deviation was not estimable as there was only one subject evaluable for the arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    2
    0 [7]
    1
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    6.29 ( 2.638 )
    ( )
    -2.27 ( 99999 )
    Notes
    [7] - All subjects for abituzumab 500 mg arm dropped out before the analysis was conducted.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number of subjects who died and number of censored subjects. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo).
    End point type
    Secondary
    End point timeframe
    Time from date of randomization until death, assessed up to 2 years
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    10
    5
    9
    Units: subjects
    number (not applicable)
        Number of Deaths
    0
    1
    0
        Number of censored
    10
    4
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 1 (Interstitial Lung Disease [ILD])

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    End point title
    		 Number of Subjects With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 1 (Interstitial Lung Disease [ILD])
    End point description
    Clinically Meaningful Progression SSc-ILD was defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (>=)10%; Relative decrease from baseline in FVC % predicted of >=5% to less than (<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted >=15%. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo).
    End point type
    Secondary
    End point timeframe
    upto Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    10
    5
    9
    Units: subjects
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Meaningful Progression of Systemic sclerosis (SSc) by Meeting Criterion 2 (SSc Progression other than ILD)

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    End point title
    		 Number of Subjects with Clinically Meaningful Progression of Systemic sclerosis (SSc) by Meeting Criterion 2 (SSc Progression other than ILD)
    End point description
    Clinically Meaningful Progression SSc other than ILD was defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction <=45%); Pulmonary arterial hypertension requiring treatment. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo).
    End point type
    Secondary
    End point timeframe
    upto Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    10
    5
    9
    Units: subjects
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Meaningful Progression

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    End point title
    		 Number of Subjects with Clinically Meaningful Progression
    End point description
    Subjects meeting one or both of the below criteria was considered as having clinically meaningful disease progression. Clinically Meaningful SSc-ILD defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (>=)10%; Relative decrease from baseline in FVC % predicted of >=5% to less than (<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted >=15%. Clinically Meaningful SSc progression other than ILD defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction <=45%); Pulmonary arterial hypertension requiring treatment. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo).
    End point type
    Secondary
    End point timeframe
    upto Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    10
    5
    9
    Units: subjects
    0
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Absolute Decrease From Baseline of FVC Percentage (%) Predicted Greater than or Equal to (>=) 10% on 2 or more Consecutive Occasions at Least 4 Weeks Apart

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    End point title
    		 Number of Subjects With Absolute Decrease From Baseline of FVC Percentage (%) Predicted Greater than or Equal to (>=) 10% on 2 or more Consecutive Occasions at Least 4 Weeks Apart
    End point description
    FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. mITT population was defined as all randomized subjects who receive at least 1 dose of study drug (including placebo).
    End point type
    Secondary
    End point timeframe
    upto Week 52
    End point values
    		 Placebo Abituzumab 500 milligrams (mg) Abituzumab 1500 mg
    Number of subjects analysed
    10
    5
    9
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to 2 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Abituzumab 500 milligrams (mg)
    Reporting group description
    		 Subjects received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Reporting group title
    Abituzumab 1500 mg
    Reporting group description
    		 Subjects received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

    Serious adverse events
    		 Abituzumab 500 milligrams (mg) Placebo Abituzumab 1500 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Neutrophil count increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Small fibre neuropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Abituzumab 500 milligrams (mg) Placebo Abituzumab 1500 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    9 / 10 (90.00%)
    8 / 9 (88.89%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    1
    2
    Generalised oedema
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Impaired healing
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Multiple allergies
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 10 (30.00%)
    3 / 9 (33.33%)
         occurrences all number
    0
    3
    3
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    2
    Interstitial lung disease
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    1
    Nasal dryness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Pulmonary hypertension
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood urine present
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Platelet count increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Protein urine present
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    1
    2
    Hypoaesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Lethargy
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 10 (30.00%)
    3 / 9 (33.33%)
         occurrences all number
    1
    3
    3
    Dry mouth
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    1
    2
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Dermal cyst
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Intertrigo
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Rosacea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Skin hypertrophy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Eye pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    1
    2
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Bursitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Fibromyalgia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Synovial cyst
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 10 (40.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    4
    0
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    2
    Onychomycosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2016
    To remove the Dyspnea-12 index assessment; To decrease the frequency of select quality of life assessments; To specify the required visits following discontinuation of Investigational Medicinal Product (IMP); To update the number of planned sites; To include criteria for the classification of systemic sclerosis to the protocol appendices; To include minor corrections and clarifications to the clinical trial protocol.

    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.
    The analysis of outcome measures at Week 104 wasn't conducted as the study was terminated due to the difficulties experienced in identifying subjects who meet the eligibility criteria of the trial.
    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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