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    Clinical Trial Results:
    A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease

    Summary
    EudraCT number
    		 2015-001963-37
    Trial protocol
    		 LV   EE   SK   SE   HU   AT   CZ   GB   DE   ES   PT   BE   DK   BG   GR   HR   FI   IT  
    Global end of trial date
    04 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2019
    First version publication date
    24 Jan 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GED-0301-CD-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02641392
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celgene Corporation
    Sponsor organisation address
    86 Morris Avenue, Summit, United States, 07901
    Public contact
    Clinical Trial Disclosure, Celgene Corporation, 01 888-260-1599, ClinicalTrialDisclosure@celgene.com
    Scientific contact
    Guillermo Rossiter, Celgene Corporation, 01 9088976467, grossiter@celgene.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?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the long-term safety of oral GED-0301 in subjects with Crohn’s disease (CD).
    Protection of trial subjects
    Patient Confidentiality, Informed Consent, Archiving of Essential Documents
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 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
    Slovakia: 7
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Turkey: 5
    Country: Number of subjects enrolled
    Ukraine: 11
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 29
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Canada: 29
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Israel: 23
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Norway: 4
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Serbia: 1
    Worldwide total number of subjects
    310
    EEA total number of subjects
    186
    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)
    4
    From 65 to 84 years
    299
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 310 adult participants who had previously participated in the main study GED-0301-CD-002 were enrolled at 167 study sites in 29 countries. .

    Pre-assignment
    Screening details
    		 Includes participants with Crohn's disease who had previously participated in the main study GED-0301-CD-002 through Week 12 at minimum and completed participation through the last treatment visit at Week 52, or met the "early escape criteria" and were discontinued beginning at Week 12 through Week 52.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GED-0301 40 mg 4 Weeks Alt
    Arm description
    		 Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GED-0301
    Investigational medicinal product code
    Other name
    Mongersen
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208

    Arm title
    		 GED-0301 40 mg
    Arm description
    		 Participants received continuous GED-0301 40 mg daily up to week 208.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GED-0301
    Investigational medicinal product code
    Other name
    Mongersen
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received continuous GED-0301 40 mg daily, up to week 208.

    Arm title
    		 GED-0301 160 mg 4 Weeks Alt
    Arm description
    		 Participants received one of three dose regimens up to week 208: (1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GED-0301
    Investigational medicinal product code
    Other name
    Mongersen
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one of three dose regimens up to week 208: (1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one of three dose regimens up to week 208: (1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks

    Number of subjects in period 1
    		GED-0301 40 mg 4 Weeks Alt GED-0301 40 mg GED-0301 160 mg 4 Weeks Alt
    Started
    4
    13
    293
    Completed
    0
    0
    0
    Not completed
    4
    13
    293
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    -
    -
    17
         Adverse event, non-fatal
    -
    1
    25
         Miscellaneous
    -
    -
    3
         Study Terminated by Sponsor
    4
    12
    144
         Lost to follow-up
    -
    -
    2
         Lack of efficacy
    -
    -
    101

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GED-0301 40 mg 4 Weeks Alt
    Reporting group description
    		 Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208.

    Reporting group title
    GED-0301 40 mg
    Reporting group description
    		 Participants received continuous GED-0301 40 mg daily up to week 208.

    Reporting group title
    GED-0301 160 mg 4 Weeks Alt
    Reporting group description
    		 Participants received one of three dose regimens up to week 208: (1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks.

    Reporting group values
    		 GED-0301 40 mg 4 Weeks Alt GED-0301 40 mg GED-0301 160 mg 4 Weeks Alt Total
    Number of subjects
    		 4 13 293 310
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 4 13 286 303
        From 65-84 years
    		 0 0 7 7
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.3 ( 12.34 ) 41.8 ( 14.21 ) 38.1 ( 12.30 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 3 6 136 145
        Male
    		 1 7 157 165
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 2 2
        Asian
    		 0 3 10 13
        Black or African American
    		 0 0 3 3
        White
    		 4 9 264 277
        Not Collected or Reported
    		 0 1 10 11
        Other
    		 0 0 4 4
    Duration of Crohn's Disease
    Units: Years
        arithmetic mean (standard deviation)
    		 7.25 ( 6.529 ) 9.25 ( 6.307 ) 10.56 ( 8.503 ) -
    Baseline Crohn's Disease Activity (CDAI) Score
    The Crohn's Disease Activity Index (CDAI) is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    		 316.9 ( 96.90 ) 309.2 ( 43.10 ) 307.5 ( 62.74 ) -

    End points

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    End points reporting groups
    Reporting group title
    GED-0301 40 mg 4 Weeks Alt
    Reporting group description
    		 Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208.

    Reporting group title
    GED-0301 40 mg
    Reporting group description
    		 Participants received continuous GED-0301 40 mg daily up to week 208.

    Reporting group title
    GED-0301 160 mg 4 Weeks Alt
    Reporting group description
    		 Participants received one of three dose regimens up to week 208: (1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks.

    Primary: Number of Participants with Treatment Emergent Adverse Events

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events [1]
    End point description
    A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non- serious or serious) = symptoms causing severe discomfort/pain.
    End point type
    Primary
    End point timeframe
    From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
    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 were performed as the study was terminated.
    End point values
    		 GED-0301 40 mg 4 Weeks Alt GED-0301 40 mg GED-0301 160 mg 4 Weeks Alt
    Number of subjects analysed
    4
    13
    293
    Units: Participants
        Any TEAE
    1
    6
    189
        Any Drug-Related TEAE
    0
    1
    43
        Any Severe TEAE
    0
    0
    38
        Any Serious TEAE (SAE)
    1
    0
    41
        Any Serious Drug-Related TEAE
    0
    0
    4
        Any TEAE Leading to IP Interruption
    0
    0
    7
        Any TEAE Leading to IP Withdrawal
    0
    1
    27
        Any TEAE Leading to Death
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first day of GED-0301 until 28 days after the last dose of IP.
    Adverse event reporting additional description
    Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    GED-0301 40 mg 4 Weeks Alt
    Reporting group description
    		 Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208.

    Reporting group title
    GED-0301 40 mg
    Reporting group description
    		 Participants received continuous GED-0301 40 mg daily, up to week 208

    Reporting group title
    GED-0301 160 mg 4 Weeks Alt
    Reporting group description
    		 Participants received one of three dose regimens up to week 208; (1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks.

    Serious adverse events
    		 GED-0301 40 mg 4 Weeks Alt GED-0301 40 mg GED-0301 160 mg 4 Weeks Alt
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    41 / 293 (13.99%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    ELECTROCARDIOGRAM T WAVE INVERSION
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 293 (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
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ANASTOMOTIC ULCER HAEMORRHAGE
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         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
    DROWNING
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    FATIGUE
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERTHERMIA
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    2 / 293 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANAL FISTULA
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    2 / 293 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANAL STENOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CROHN'S DISEASE
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    12 / 293 (4.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ILEAL STENOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    5 / 293 (1.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTESTINAL STENOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LARGE INTESTINAL STENOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    4 / 293 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUBILEUS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    2 / 293 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ACUTE FEBRILE NEUTROPHILIC DERMATOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    VESICAL FISTULA
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ANKYLOSING SPONDYLITIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BACK PAIN
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         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
    ABDOMINAL ABSCESS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANAL ABSCESS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    3 / 293 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CAMPYLOBACTER GASTROENTERITIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GROIN ABSCESS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INFECTIOUS COLITIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PERIRECTAL ABSCESS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    2 / 293 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    POSTOPERATIVE ABSCESS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY SEPSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SALMONELLOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VULVAL ABSCESS
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GED-0301 40 mg 4 Weeks Alt GED-0301 40 mg GED-0301 160 mg 4 Weeks Alt
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    6 / 13 (46.15%)
    92 / 293 (31.40%)
    Investigations
    ELECTROCARDIOGRAM T WAVE INVERSION
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 293 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    RADIUS FRACTURE
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    CARDIAC VALVE DISEASE
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 293 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    16 / 293 (5.46%)
         occurrences all number
    0
    0
    18
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    29 / 293 (9.90%)
         occurrences all number
    0
    1
    35
    ANAL FISTULA
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    APHTHOUS ULCER
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    CROHN'S DISEASE
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    30 / 293 (10.24%)
         occurrences all number
    0
    1
    35
    DIARRHOEA
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    ILEAL STENOSIS
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    GALLBLADDER DISORDER
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 293 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    27 / 293 (9.22%)
         occurrences all number
    0
    2
    29
    Infections and infestations
    CYSTITIS
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 293 (0.00%)
         occurrences all number
    0
    1
    0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 13 (7.69%)
    20 / 293 (6.83%)
         occurrences all number
    1
    2
    28
    Metabolism and nutrition disorders
    HYPERLIPIDAEMIA
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 293 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jan 2017
    1. The addition of adolescent subjects into this long-term active treatment extension study who previously participated in the Phase 3 Study GED-0301-CD-003. 2. New sections were added to the protocol that applied specifically to adolescent subjects. 3. The objectives, endpoints, inclusion/exclusion criteria, table of events, procedures, and assessments sections were separated for the adult and adolescent subjects throughout the protocol, where appropriate, to clearly indicate protocol information which applied specifically to adult versus adolescent subjects. 4. Previous GED-0301-CD-003 subjects were to have an ileocolonoscopy with intestinal mucosal biopsies during the screening period and at Week 12 in the core GED-0301-CD-003 study. A Week 40 ileocolonoscopy with intestinal mucosal biopsies was to be included in this study for these adult subjects, as well as the adolescent subjects, to determine if mucosal healing and/or endoscopic remission was achieved after 52 weeks of GED-0301 therapy from the combined studies (12 weeks from GED-0301-CD-003 and 40 weeks from GED-0301-CD-004) in the adult (and adolescent) populations. 5. The Week 12 clinical criteria were added for discontinuing subjects who did not achieve a minimum level of improvement by Week 12.

    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.
    Following a recommendation by the Data Monitoring Committee (DMC), the study was terminated early by Celgene on 19 Oct 2017 due to a lack of emerging benefit; no emergent safety findings were noted.
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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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