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    Clinical Trial Results:
    A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis

    Summary
    EudraCT number
    		 2019-001279-34
    Trial protocol
    		 GB   ES   DE   BE   IT  
    Global end of trial date
    13 Apr 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Apr 2022
    First version publication date
    08 Mar 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    To correct a mistake regarding the timeframe for the adverse events which was expressed in "days" instead of "weeks"

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1690-CL-206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03976648
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3 , Mechelen, Belgium, 2800
    Public contact
    Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    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
    13 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of GLPG1690 in subjects 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
    18 Jul 2019
    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
    Belgium: 12
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    31
    EEA total number of subjects
    17
    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)
    26
    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, Italy, Spain, the United Kingdom, and the United States. The first participant was screened on 18 Jul 2019. The last study visit occurred on 13 Apr 2021. The treatment duration was planned for 104 weeks but the study was terminated at 91 weeks.

    Pre-assignment
    Screening details
    		 A total of 31 participants who completed 24-week double-blind treatment in the GLPG1690-CL-204 (2018-001817-33) study were rolled over and randomized in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GLPG1690 600 mg
    Arm description
    		 Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1690
    Investigational medicinal product code
    Other name
    ziritaxestat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received GLPG1690 600 mg orally once daily.

    Arm title
    		 Placebo
    Arm description
    		 Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1690
    Investigational medicinal product code
    Other name
    ziritaxestat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received GLPG1690 600 mg orally once daily.

    Number of subjects in period 1
    		GLPG1690 600 mg Placebo
    Started
    21
    10
    Completed
    0
    0
    Not completed
    21
    10
         Study terminated by sponsor
    21
    8
         Adverse event
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    		 Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.

    Reporting group values
    		 GLPG1690 600 mg Placebo Total
    Number of subjects
    		 21 10 31
    Age categorical
    Units: Subjects
        Less than or equal to 45 years
    		 7 4 11
        Greater than 45 years
    		 14 6 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.4 ( 13.58 ) 49.4 ( 18.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 6 21
        Male
    		 6 4 10
    Race
    Units: Subjects
        White
    		 21 9 30
        Asian
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Non-hispanic or Latino
    		 20 10 30

    End points

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    End points reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    		 Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.

    Primary: 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 [1]
    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 the 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 the 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. The OLE-FAS was defined as all participants who had at least one intake of investigational product.
    End point type
    Primary
    End point timeframe
    Day 1 up to 91 weeks
    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: No statistical analysis was planned for this endpoint.
    End point values
    		 GLPG1690 600 mg Placebo
    Number of subjects analysed
    21
    10
    Units: participants
        TEAEs
    21
    10
        Serious TEAEs
    6
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to 91 weeks
    Adverse event reporting additional description
    Participants in the OLE-FAS were analyzed.
    Assessment type
    		 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 who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (2018-001817-33) study, received GLPG1690 600 mg orally once daily up to 91 weeks.

    Serious adverse events
    		 GLPG1690 600 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 21 (28.57%)
    3 / 10 (30.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial tachycardia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin hypertrophy
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Colonic abscess
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GLPG1690 600 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    10 / 10 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    General disorders and administration site conditions
    Discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nodule
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Peripheral swelling
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 10 (10.00%)
         occurrences all number
    5
    1
    Pyrexia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Reproductive system and breast disorders
    Breast fibrosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 21 (33.33%)
    1 / 10 (10.00%)
         occurrences all number
    9
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Weight increased
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Bundle branch block left
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Bundle branch block right
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Pericarditis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 10 (20.00%)
         occurrences all number
    3
    3
    Headache
         subjects affected / exposed
    6 / 21 (28.57%)
    2 / 10 (20.00%)
         occurrences all number
    6
    3
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Normocytic anaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Eye disorders
    Altered visual depth perception
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Abdominal distension
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Anal incontinence
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    8 / 21 (38.10%)
    4 / 10 (40.00%)
         occurrences all number
    13
    7
    Dyspepsia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Dysphagia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Eructation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastric antral vascular ectasia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Oesophagitis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 10 (10.00%)
         occurrences all number
    6
    1
    Skin and subcutaneous tissue disorders
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Digital pitting scar
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Hair growth abnormal
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Night sweats
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Perioral dermatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Rash macular
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Scleroderma associated digital ulcer
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    6 / 21 (28.57%)
    1 / 10 (10.00%)
         occurrences all number
    14
    4
    Skin lesion
         subjects affected / exposed
    5 / 21 (23.81%)
    1 / 10 (10.00%)
         occurrences all number
    6
    1
    Telangiectasia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Back pain
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Bursitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Muscle spasms
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    2
    Pain in extremity
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    2
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Cellulitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Infected skin ulcer
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 21 (23.81%)
    1 / 10 (10.00%)
         occurrences all number
    7
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 21 (28.57%)
    0 / 10 (0.00%)
         occurrences all number
    11
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Dyslipidaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Lactose intolerance
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         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
    08 Jan 2020
    - The protocol was updated to extend the duration of the treatment period from 52 weeks to 104 weeks. - The information on ziritaxestat was updated in line with the latest Investigator’s Brochure. - Events meeting the following defined criteria were to be reported as an SAE and IP was to be discontinued: • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 8x upper limit of normal (ULN) • AST or ALT ≥ 3x ULN with signs of severe liver damage (i.e., with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia [> 5%], and/or total bilirubin ≥ 1.5x ULN or international normalized ratio > 1.5)

    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 benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.
    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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