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    Clinical Trial Results:
    Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Disease

    Summary
    EudraCT number
    		 2014-001892-30
    Trial protocol
    		 HU   BE  
    Global end of trial date
    09 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2020
    First version publication date
    16 Oct 2020
    Other versions
    Summary report(s)
    		 Cancelled before enrollment statement

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1205-CL-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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, +32 15342900, medicalinfo@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342900, 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
    09 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate efficacy in terms of the change in Crohn’s Disease Activity Index (CDAI) score compared with baseline following 12 weeks of treatment with GLPG1205 100 mg once daily (qd) versus placebo in subjects with active moderate Crohn’s Disease (CD).
    Protection of trial subjects
    This study will be conducted in accordance with the current ICH-GCP Guideline E6. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting studies that involve the participation of human subjects. 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 must explain the study and the implications of participation (e.g., objectives, methods, anticipated benefits, and possible risks) to potential subjects according to local regulations prior to any trial related activity. Subjects will be informed that their participation is voluntary and that they may withdraw from the study at any time. They will be informed that choosing not to participate or to withdraw from the study will not have an impact on the care the subject will receive for the treatment of his/her disease. In case the subject is unable to read and write, an impartial witness must confirm the informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 GLPG1205
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1205
    Investigational medicinal product code
    G321605
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects will receive 100 mg GLPG1205 (2 capsules of 50 mg) or placebo qd for 12 weeks. The GLPG1205 or placebo capsules should be taken orally with a glass of water in the morning. Subjects will be instructed to swallow the study drug whole, and not chew the drug prior to swallowing.

    Number of subjects in period 1
    		GLPG1205
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 99999 99999
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    GLPG1205
    Reporting group description
    		 -

    Primary: CDAI baseline score

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    End point title
    		 CDAI baseline score [1]
    End point description
    Difference in CDAI change from baseline between GLPG1205- and placebo-treated subjects at Week 12.
    End point type
    Primary
    End point timeframe
    N/A
    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 subjects were enrolled in the trial hence results are not available.
    End point values
    		 GLPG1205
    Number of subjects analysed
    99999 [2]
    Units: Subjects
        number (not applicable)
    0
    Notes
    [2] - No subjects were enrolled in the trial hence results are not available.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first study drug administration until the last follow-up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    GLPG1205
    Reporting group description
    		 GLPG1205 Dose A

    Serious adverse events
    		 GLPG1205
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GLPG1205
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects were enrolled in the trial hence results are not available .

    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.
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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