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    Clinical Trial Results:
    A Randomized, Double-Blind, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Dose De-Escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission

    Summary
    EudraCT number
    		 2022-000719-30
    Trial protocol
    		 PL   CZ   FR   ES   BE   IT  
    Global end of trial date
    09 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2024
    First version publication date
    22 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG0634-CL-341
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05479058
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 milligrams (mg) filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.
    Protection of trial subjects
    This clinical study was conducted 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 clinical study. It was also carried out in conformity with the protocol, the International Council for Harmonisation for Good Clinical Practice (ICH-GCP) Guideline E6 (R2), and local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2022
    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
    Poland: 7
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    22
    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)
    17
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who were in clinical remission with filgotinib 200 mg once daily for at least 2 consecutive quarterly visits in the ongoing long-term extension (LTE) SELECTION-LTE study (GS-US-418-3899; NCT02914535) and who met the eligibility criteria, were rolled over and randomized to this study.

    Pre-assignment
    Screening details
    		 The trial was originally designed with the primary endpoint to be assessed at Week 48 after which participants would have received unblinded treatment. Due to early termination, none of the participants completed 48 weeks. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.

    Period 1
    Period 1 title
    Overall (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
    		 Filgotinib 200 mg
    Arm description
    		 Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, GLPG0634
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally once daily

    Arm title
    		 Filgotinib 100 mg
    Arm description
    		 Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally once daily

    Number of subjects in period 1
    		Filgotinib 200 mg Filgotinib 100 mg
    Started
    11
    11
    Completed
    0
    0
    Not completed
    11
    11
         Consent withdrawn by subject
    1
    1
         Study terminated by sponsor
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.

    Reporting group values
    		 Filgotinib 200 mg Filgotinib 100 mg Total
    Number of subjects
    		 11 11 22
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.5 ( 8.5 ) 58.3 ( 10.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 3 5 8
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 10 11 21
    Race
    Units: Subjects
        Asian
    		 1 0 1
        White
    		 10 11 21

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.

    Primary: Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)

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    End point title
    		 Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) [1]
    End point description
    The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity. The mMCS remission was defined as a total score of score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0. Corticosteroid-free mMCS remission was defined as being free of corticosteroids for at least 12 weeks.
    End point type
    Primary
    End point timeframe
    Week 48
    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 participant reached the Week 48 time point, hence the data was not collected and analyzed.
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - Due to early termination, Week 48 time point was not reached. Data was not collected and analyzed.
    [3] - Due to early termination, Week 48 time point was not reached. Data was not collected and analyzed.
    No statistical analyses for this end point

    Secondary: Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare

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    End point title
    		 Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
    End point description
    PRO2 flare was defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore ≥2, and rectal bleeding subscore ≥1. PRO2 included items of stool frequency and rectal bleeding. The range of each item score was 0 to 3 with higher scores indicating more severe disease. Participants in the Full Analysis Set (FAS) (all randomized participants who were administered study drug at least once) were analyzed. '99999' signifies that due to insufficient number of participants with PRO2 flare, the median and 95% CI data could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    11
    11
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Time to ES-Confirmed UC Flare

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    End point title
    		 Time to ES-Confirmed UC Flare
    End point description
    An ES-confirmed UC flare was defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point. Each subscore graded from 0 to 3 with higher scores indicating more severe disease. Participants in the FAS were analyzed. '99999' signifies that due to insufficient number of participants with ES-confirmed UC flare, the median and 95% CI data could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    11
    11
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Change From Baseline in C-Reactive Protein (CRP)

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    End point title
    		 Change From Baseline in C-Reactive Protein (CRP)
    End point description
    CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. Participants in the FAS with available data were analyzed. '99999' signifies that data at Week 48 was not collected and analyzed because the study was terminated prior to any participant reaching the Week 48 time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    9
    10
    Units: milligrams per liter (mg/L)
    arithmetic mean (standard deviation)
        Change from Baseline at Week 4 (n=9, n=10)
    0.166 ( 0.533 )
    1.713 ( 4.423 )
        Change from Baseline at Week 12 (n=6, n=7)
    0.532 ( 1.128 )
    10.406 ( 26.944 )
        Change from Baseline at Week 24 (n=5, n=5)
    0.156 ( 0.128 )
    16.002 ( 34.093 )
        Change from Baseline at Week 36 (n=3, n=3)
    0.367 ( 0.192 )
    1.443 ( 0.525 )
        Change from Baseline at Week 48 (n=0, n=0)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fecal Calprotectin (FCP)

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    End point title
    		 Change From Baseline in Fecal Calprotectin (FCP)
    End point description
    Fecal calprotectin, a very stable biomarker, was a 36 kilodalton calcium and zinc binding protein of S-100 protein family which was neutrophil derived. It represents 60% of cytosolic proteins in neutrophils and was a measurement of neutrophil migration to the gastrointestinal tract. Participants in the FAS with available data were analyzed. '99999' signifies that data at Week 48 was not collected and analyzed because the study was terminated prior to any participant reaching the Week 48 time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    7
    8
    Units: milligrams per kilogram (mg/kg)
    arithmetic mean (standard deviation)
        Change from Baseline at Week 4 (n=7, n=8)
    -27.6 ( 37.2 )
    142.5 ( 307.7 )
        Change from Baseline at Week 12 (n=7, n=5)
    -16.7 ( 48.1 )
    920.6 ( 1996.2 )
        Change from Baseline at Week 24 (n=3, n=4)
    -52.0 ( 54.6 )
    374.3 ( 674.8 )
        Change from Baseline at Week 36 (n=2, n=3)
    -46.5 ( 65.8 )
    -8.0 ( 70.4 )
        Change from Baseline at Week 48 (n=0, n=0)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score

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    End point title
    		 Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
    End point description
    The IBDQ is disease-specific questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in participants with the Inflammatory Bowel Disease (IBD). It comprised of 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions). The IBDQ total score was calculated as the sum of the responses (each ranging from 1 [severe problem] to 7 [normal health]) to all 32 questions. Total IBDQ score ranged from 32 to 224 with a higher score indicating a better HRQoL.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: score on scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - Due to early termination, Week 48 time point was not reached. Data was not collected and analyzed.
    [5] - Due to early termination, Week 48 time point was not reached. Data was not collected and analyzed.
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
    End point description
    An adverse event (AE) was any untoward medical occurrence, new or worsening of any preexisting condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with this treatment. A TEAE was defined as an AE which had a start date equal to or after the date of the first administration of study drug in this study and no later than 30 days after last administration of study drug; And was either a newly reported event, or a worsening of an existing event. Serious TEAE was defined as a TEAE that Resulted in death and was life-threatening; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly / birth defect; Was medically significant. Participants in the Safety Analysis Set (all randomized participants who were administered study drug at least once) were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg
    Number of subjects analysed
    11
    11
    Units: Participants
        TEAEs
    6
    6
        Serious TEAEs
    0
    0
        TEAEs Leading to Treatment Discontinuation
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 48
    Adverse event reporting additional description
    The Safety Analysis Set included all randomized participants who were administered study drug at least once.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Participants received filgotinib 100 mg and placebo to match filgotinib 200 mg once daily orally.

    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Participants received filgotinib 200 mg and placebo to match filgotinib 100 mg once daily orally.

    Serious adverse events
    		 Filgotinib 100 mg Filgotinib 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Filgotinib 100 mg Filgotinib 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 11 (54.55%)
    6 / 11 (54.55%)
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Tendon rupture
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    Postmenopause
         subjects affected / exposed [1]
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Tendonitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Campylobacter infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is a sex-specific AE. Only female participants were at risk.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2023
    − Clarifications were added regarding UC flare, biopsies, corticosteroids, food intake, End of treatment visit, unblinding of participants at the study primary analysis endpoint, and hepatitis B virus surveillance. − The eligibility criteria and screening assessments were updated, rescreening allowed, and the screening period was extended. − The definitions of women of childbearing potential and postmenopausal female were changed.

    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.
    Study was terminated as the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation.
    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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