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    Clinical Trial Results:
    Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF).

    Summary
    EudraCT number
    		 2015-004157-41
    Trial protocol
    		 GB   IT  
    Global end of trial date
    02 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2018
    First version publication date
    13 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1690-CL-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02738801
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium,
    Public contact
    Clinical Trial Information Desk, Galapagos NV, +32 15 342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15 342 900, rd@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
    07 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study were: - to evaluate the safety and tolerability of GLPG1690. - to characterize the PK and PD properties of GLPG1690. The key secondary objectives of the study were: - to evaluate the change from baseline in forced vital capacity (FVC). - to evaluate the change in functional respiratory imaging (FRI) parameters. - to evaluate the change in quality of life measures.
    Protection of trial subjects
    This study was conducted in accordance with the current International Council on Harmonization (ICH) –Good Clinical Practice (GCP) Guideline E6.Compliance with this standard provides public assurance that the rights, safety, and well-being of study subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical study data are credible. The investigator or designated personnel had to explain the study and the implications of participation (e.g., objectives, methods, anticipated benefits, and possible risks) to potential subjects or their legally acceptable representatives prior to any study-related activity. Subjects were informed that their participation was voluntary and that they could withdraw from thestudy at any time. They were informed that choosing not to participate or to withdraw from the study would not have an impact on the care the subject received for the treatment of his/her disease. In case the subject was unable to read and write, an impartial witness had to confirm the informed consent. The subject was given sufficient time to read the ICF and to ask additional questions. After this explanation and before entry in the study, consent had to be appropriately recorded by means of the subject's personally dated signature or by the signature of an independent witness who certified the subject's consent in writing. After having obtained the consent, a copy of the signed and dated informed consent had to be given to the subject.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 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
    United Kingdom: 4
    Country: Number of subjects enrolled
    Ukraine: 19
    Worldwide total number of subjects
    23
    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)
    8
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 24 Mar 2016 (first subject signed ICF) until 02 May 2017 (last contact with any subject in the study). Three (3) countries (Italy, Ukraine, and the United Kingdom [UK]) participated in the study and 8 investigators (6 from Ukraine and 2 from the UK) enrolled subjects.

    Pre-assignment
    Screening details
    		 A total of 72 subjects were screened of whom 49 were not enrolled. Twenty three (23) subjects were randomized.

    Period 1
    Period 1 title
    Overall Trial (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
    		 GLPG1690 - 600 mg q.d.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1690
    Investigational medicinal product code
    G451990
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral doses of 600 mg GLPG1690 (3 capsules of 200 mg) were administered in the morning during 12 weeks. GLPG1690 was presented as capsules for oral use (size 00), containing 200 mg G451990 (G451990 is the compound code for GLPG1690).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match (3 capsules) was administered in the morning during 12 weeks. Placebo was presented as matching capsules for oral use (size 00).

    Number of subjects in period 1
    		GLPG1690 - 600 mg q.d. Placebo
    Started
    17
    6
    Completed
    15
    5
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1690 - 600 mg q.d.
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 GLPG1690 - 600 mg q.d. Placebo Total
    Number of subjects
    		 17 6 23
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 3 8
        From 65-84 years
    		 12 3 15
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 67 (54 to 79) 64 (52 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 7 1 8
        Male
    		 10 5 15
    Race
    Units: Subjects
        White
    		 17 6 23
    BMI
    Units: kg/m²
        median (full range (min-max))
    		 28.00 (23.7 to 39.1) 32.20 (23.5 to 43.1) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG1690 - 600 mg q.d.
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Safety - TEAE (Treatment-Emergent Adverse Events)

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    End point title
    		 Safety - TEAE (Treatment-Emergent Adverse Events) [1]
    End point description
    Clinical safety was evaluated by assessing treatment-emergent AEs (TEAEs) and results of physical examinations, laboratory assessments, ECG, and vital signs in a descriptive manner.
    End point type
    Primary
    End point timeframe
    From first study drug administration until the last follow-up visit.
    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: Descriptive analysis only.
    End point values
    		 GLPG1690 - 600 mg q.d. Placebo
    Number of subjects analysed
    17
    6
    Units: Subjects
        Any TEAE
    11
    4
        Severe TEAE
    1
    1
        Serious TEAE
    1
    2
        Treatment related TEAE
    2
    0
        Discontinuation due to AE
    1
    1
    No statistical analyses for this end point

    Primary: PK - Cmax

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    End point title
    		 PK - Cmax [2] [3]
    End point description
    Maximum observed plasma concentration.
    End point type
    Primary
    End point timeframe
    PK samples were taken pre-dose at multiple timepoints. At Day 28, in addition to pre-dose, samples were taken 1.5h, 4h, and 6h postdose. The PK parameter Week 4 (based on pre-dose and postdose samples) has been provided.
    Notes
    [2] - 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: Descriptive analysis only.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo arm has been excluded.
    End point values
    		 GLPG1690 - 600 mg q.d.
    Number of subjects analysed
    15
    Units: μg/mL
        arithmetic mean (standard deviation)
    6.06 ( 4.92 )
    No statistical analyses for this end point

    Primary: PK - AUC0-τ

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    End point title
    		 PK - AUC0-τ [4] [5]
    End point description
    Area under the plasma concentration time curve for the dosing interval (24 hours).
    End point type
    Primary
    End point timeframe
    PK samples were taken pre-dose at multiple timepoints. At Day 28, in addition to pre-dose, samples were taken 1.5h, 4h, and 6h postdose. The PK parameter Week 4 (based on pre-dose and postdose samples) has been provided.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis only.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo arm has been excluded.
    End point values
    		 GLPG1690 - 600 mg q.d.
    Number of subjects analysed
    15
    Units: μg.h/mL
        arithmetic mean (standard deviation)
    55.6 ( 46.6 )
    No statistical analyses for this end point

    Primary: PD - LPA 18:2

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    End point title
    		 PD - LPA 18:2 [6]
    End point description
    Plasma was collected for the evaluation of lipid lysophosphatidic acid (LPA) 18:2 for change from baseline. Observed case, intent-to-treat (ITT) population.
    End point type
    Primary
    End point timeframe
    A 12-week treatment period. PD samples were taken pre-dose at multiple timepoints. At Day 28, in addition to pre-dose, samples were taken 1.5h and 6h postdose.
    Notes
    [6] - 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: Descriptive analysis only.
    End point values
    		 GLPG1690 - 600 mg q.d. Placebo
    Number of subjects analysed
    16 [7]
    6 [8]
    Units: Peak area ratio
    arithmetic mean (standard error)
        Week 4 - pre-dose
    -0.1817 ( 0.0729 )
    -0.0875 ( 0.1085 )
        Week 4 - 1.5h postdose
    -0.2885 ( 0.0702 )
    -0.0454 ( 0.0619 )
        Week 4 - 6h postdose
    -03049 ( 0.00752 )
    -01123 ( 0.1608 )
        Week 12 - pre-dose
    -0.2466 ( 0.0724 )
    -0.010 ( 0.0688 )
    Notes
    [7] - Week 4 (pre-dose) N=16 Week 4 (1.5h, 6h postdose) N=15 Week 12 (pre-dose) N=16
    [8] - Week 4 (all time points) N=5 Week 12 (pre-dose) N=6
    No statistical analyses for this end point

    Secondary: Change from baseline in FVC

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    End point title
    		 Change from baseline in FVC
    End point description
    To evaluate the change from baseline in forced vital capacity. Last observation carried forward, ITT population.
    End point type
    Secondary
    End point timeframe
    A 12-week treatment period. The parameter for Week 12 has been provided.
    End point values
    		 GLPG1690 - 600 mg q.d. Placebo
    Number of subjects analysed
    16
    6
    Units: Liter
        arithmetic mean (standard error)
    -0.1238 ( 0.08719 )
    -0.2588 ( 0.03447 )
    No statistical analyses for this end point

    Secondary: The change in FRI parameters - Specific Airway Volume

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    End point title
    		 The change in FRI parameters - Specific Airway Volume
    End point description
    To evaluate the change in functional respiratory imaging (FRI) parameters specific airway volume from baseline. Observed case, ITT population.
    End point type
    Secondary
    End point timeframe
    A 12-week treatment period. The Parameter for Week 12 has been provided.
    End point values
    		 GLPG1690 - 600 mg q.d. Placebo
    Number of subjects analysed
    15
    3
    Units: mL/L
        arithmetic mean (standard error)
    0.0786 ( 0.49489 )
    3.0380 ( 1.37106 )
    No statistical analyses for this end point

    Secondary: The change in FRI parameters - Specific Airway Resistance

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    End point title
    		 The change in FRI parameters - Specific Airway Resistance
    End point description
    To evaluate the change in functional respiratory imaging (FRI) parameters specific airway resistance from baseline. Observed case, ITT population
    End point type
    Secondary
    End point timeframe
    A 12-week treatment period. The parameter for Week 12 has been given.
    End point values
    		 GLPG1690 - 600 mg q.d. Placebo
    Number of subjects analysed
    14
    3
    Units: kPa/sec
        arithmetic mean (standard error)
    0.0044 ( 0.00820 )
    -0.0354 ( 0.01120 )
    No statistical analyses for this end point

    Secondary: The change in Quality of Life Measures (total SGQR score)

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    End point title
    		 The change in Quality of Life Measures (total SGQR score)
    End point description
    To evaluate the change in quality of life measures from baseline (St Georges Respiratory Questionnaire total score). Last observation carried forward, ITT population.
    End point type
    Secondary
    End point timeframe
    A 12 week treatment period. The parameter for Week 12 has been provided.
    End point values
    		 GLPG1690 - 600 mg q.d. Placebo
    Number of subjects analysed
    16
    6
    Units: Ratio
        arithmetic mean (standard error)
    0.68 ( 2.820 )
    -0.37 ( 4.196 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE: from the signature of ICF until the final follow-up visit. TEAE: from first study drug administration until the final follow-up visit.
    Adverse event reporting additional description
    No subjects died.Two subjects in the placebo group and 1 subject in the GLPG1690 group had a serious TEAE. One subject in each group had a TEAE leading to the permanent discontinuation of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    GLPG1690 - 600 mg q.d.
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 GLPG1690 - 600 mg q.d. Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 6 (33.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         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 q.d. Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 17 (64.71%)
    4 / 6 (66.67%)
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram PR prolongation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Dyspnoea
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Productive cough
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Haemothorax
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    Joint swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Infected cyst
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Orchitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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