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    Clinical Trial Results:
    A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease

    Summary
    EudraCT number
    		 2015-002496-26
    Trial protocol
    		 DE   BE   ES   HU  
    Global end of trial date
    02 Jan 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Nov 2020
    First version publication date
    18 Apr 2020
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Following a comprehensive review of the previously reported study results, some corrective measures were taken to re-analyse and re-report the data which is reflected in the updated Post-Hoc Analysis Plan. All efficacy analyses for the PP and ITT population were rerun and WHO guidelines were followed for Hb normalisation.

    Trial information

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    Trial identification
    Sponsor protocol code
    ST10-01-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02680756
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shield TX (UK) Limited
    Sponsor organisation address
    Nothern Design Centre, Baltic Business Quarter, Gateshead Quays, United Kingdom, NE8 3DF
    Public contact
    Clinical Operations, Shield TX (UK) Ltd., 44 1915118511, jmitchell@shieldtx.com
    Scientific contact
    Clinical Operations, Shield TX (UK) Ltd., 44 1915118511, jmitchell@shieldtx.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
    25 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of ferric maltol and intravenous iron (FCM) in the treatment and maintenance of iron deficiency anaemia in subjects with IBD
    Protection of trial subjects
    Subjects were males or females aged ≥18 years with a confirmed diagnosis of IBD (endoscopic or biopsy). All patients were required to be in remission or to have a mild-to-moderate disease activity of IBD (as defined by a Simple Clinical Colitis Activity Index [SCCAI] >5 or a Crohn’s Disease Activity Index [CDAI] score <300 at screening). All subjects were required to have IDA, defined by a haemoglobin (Hb) concentration ≥8.0 g/dL and ≤11.0 g/dL for women OR a Hb ≥8.0 g/dL and ≤12.0 g/dL for men, as well as ferritin levels <30 ng/mL or Ferritin <100 ng/mL with Transferrin saturation (TSAT) <20% at screening. Female subjects of childbearing potential had to agree to use a reliable method of contraception until they had completed the study and for at least 4 weeks following their final study visit. Safety assessments conducted throughout the study included adverse event monitoring, routine clinical safety laboratory testing, changes in CDAI and SCCAI. Subjective Quality of Life score was also assessed over the study duration using SF-36.
    Background therapy
    		 The following concomitant medications were allowed at baseline and during the study: • ESAs, but the subject had to have been on a stable dose for the preceding 3 months before randomisation • Vitamin B12 and folic acid supplements/replacement • Immunosuppressants, including variations to dosing at the discretion of the investigator, so long as there was no clinical evidence or suspicion of the immunosuppressant contributing to the subject’s anaemia or affecting erythropoiesis. Subjects with anaemia unrelated to iron deficiency or who had received depot iron preparations within 8 weeks of screening or blood transfusions within 12 weeks of screening were excluded. Other reasons for exclusion were: oral iron treatment within 4 weeks of randomization; treatment with immunosuppressants known to induce anemia; uncorrected folate or vitamin B12 deficiency; and pregnancy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2015
    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
    Spain: 39
    Country: Number of subjects enrolled
    United States: 65
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Hungary: 53
    Worldwide total number of subjects
    250
    EEA total number of subjects
    185
    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)
    228
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening assessments included demographics, medical history, concomitant medication, physical examination, vital signs, clinical laboratory tests (including liver function, iron markers and pregnancy test for women of childbearing potential), status of their disease using SSCAI or CDAI.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferric Maltol
    Arm description
    		 Ferric maltol 30mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric maltol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule (30mg) taken bid, first thing in the morning at least 1 hour before food and concomitant medications, and last thing at night before bed at least 2 hours after food and concomitant medications. Capsules had to be taken on an empty stomach with water only with at least 8 hours between doses.

    Arm title
    		 IV Iron
    Arm description
    		 IV iron, ferric carboxymaltose
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ferric carboxymaltose
    Investigational medicinal product code
    Other name
    FCM
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects randomised to IV iron received FCM in accordance with the dosing instructions as per the local SmPC/PI. A copy of the relevant local SmPC/PI for FCM is available in the TMF. Initial dosing and the number of IV iron doses administered were calculated based on the subject’s starting Hb and weight. For ongoing treatment decisions, ferritin was measured at Visit 4 (Week 12) and Visits 5 and 6 (Week 24, and Week 36) for subjects prior to protocol amendment 7.0. Subjects continuing after Week 12 who were iron deficient (ferritin below 100 ng/mL) at any of Visits 4-6 received additional FCM doses according to the formula in the local SmPC/PI.

    Number of subjects in period 1
    		Ferric Maltol IV Iron
    Started
    125
    125
    Completed Wk 12
    109
    118
    Completed Wk 24
    79 [1]
    89 [2]
    Completed Wk 36
    57 [3]
    64 [4]
    Completed Wk 52/ET
    64 [5]
    63 [6]
    Completed Wk 54
    98
    96 [7]
    Completed
    93
    106
    Not completed
    32
    19
         Consent withdrawn by subject
    5
    5
         Physician decision
    4
    1
         Protocol violation
    1
    -
         Adverse event, non-fatal
    10
    2
         Blood transfusion during study treatment period
    -
    1
         Death
    1
    -
         Other
    3
    2
         Hb <7.5 g/dL
    -
    2
         Lost to follow-up
    7
    6
         TSAT above 60 % or ferritin above 800 mg/ml
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects includes those who had discontinued but come back for follow-up visit

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferric Maltol
    Reporting group description
    		 Ferric maltol 30mg BID

    Reporting group title
    IV Iron
    Reporting group description
    		 IV iron, ferric carboxymaltose

    Reporting group values
    		 Ferric Maltol IV Iron Total
    Number of subjects
    		 125 125 250
    Age categorical
    The subject population consists of male and female aged 18 or older with a confirmed diagnosis of IBD.
    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)
    		 115 113 228
        From 65-84 years
    		 10 12 22
        85 years and over
    		 0 0 0
    Age continuous
    The study population consisted of male and female subjects aged 18 or over with a confirmed diagnosis of IBD
    Units: years
        arithmetic mean (standard deviation)
    		 40.0 ± 14.58 40.4 ± 15.54 -
    Gender categorical
    Units: Subjects
        Female
    		 68 77 145
        Male
    		 57 48 105
    Screening Hb for randomisation
    Units: Subjects
        <10 g/dL Female or <11 g/dL Male
    		 67 67 134
        ≥10 g/dL Female or ≥11 g/dL Male
    		 58 58 116
    Baseline Hb
    Units: Subjects
        < 9.5g/dL
    		 38 35 73
        >= 9.5g/dL
    		 87 90 177
    IBD Subgroup
    Units: Subjects
        Crohn's disease
    		 79 79 158
        Ulcerative Colitis
    		 46 46 92
    Subject analysis sets

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to-treat (ITT) population included all subjects who were randomised.

    Subject analysis sets values
    		 ITT population
    Number of subjects
    250
    Age categorical
    The subject population consists of male and female aged 18 or older with a confirmed diagnosis of IBD.
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    228
        From 65-84 years
    22
        85 years and over
    0
    Age continuous
    The study population consisted of male and female subjects aged 18 or over with a confirmed diagnosis of IBD
    Units: years
        arithmetic mean (standard deviation)
    40.2 ± 15.04
    Gender categorical
    Units: Subjects
        Female
    145
        Male
    105
    Screening Hb for randomisation
    Units: Subjects
        <10 g/dL Female or <11 g/dL Male
    134
        ≥10 g/dL Female or ≥11 g/dL Male
    116
    Baseline Hb
    Units: Subjects
        < 9.5g/dL
    73
        >= 9.5g/dL
    177
    IBD Subgroup
    Units: Subjects
        Crohn's disease
    158
        Ulcerative Colitis
    92

    End points

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    End points reporting groups
    Reporting group title
    Ferric Maltol
    Reporting group description
    		 Ferric maltol 30mg BID

    Reporting group title
    IV Iron
    Reporting group description
    		 IV iron, ferric carboxymaltose

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to-treat (ITT) population included all subjects who were randomised.

    Primary: Proportion of subjects achieving either a 2 g/dL increase in Hb or normalisation of Hb (>=12 g/dL women, >=13 g/dL men) at Week 12 - re-evaluated PP

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    End point title
    		 Proportion of subjects achieving either a 2 g/dL increase in Hb or normalisation of Hb (>=12 g/dL women, >=13 g/dL men) at Week 12 - re-evaluated PP
    End point description
    The primary efficacy endpoint was the proportion of subjects achieving either a 2 g/dL increase in Hb or normalisation of Hb (>=12 g/dL women, >=13 g/dL men) at Week 12 in the re-evaluated PP population
    End point type
    Primary
    End point timeframe
    12 weeks (primary efficacy endpoint of study)
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    78
    88
    Units: Subjects
        Responder
    53
    75
        Non-responder
    25
    13
    Statistical analysis title
    		 Statistical testing Hb responder rate at 12 weeks
    Comparison groups
    Ferric Maltol v IV Iron
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.341
    Method
    		 t-test, 2-sided
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 -0.05
    Variability estimate
    Standard deviation
    Notes
    [1] - The null hypothesis for the primary efficacy analysis will be rejected (i.e., ferric maltol will be deemed non-inferior to IV Iron), if the LCL of the 95% CI for the difference (ferric maltol – IV Iron) in proportions of Hb responders at Week 12 is ≥ -20% for both the ITT analysis and the re-evaluated PP analysis. The p-value in testing the aforementioned hypotheses will be equal to one minus the confidence coefficient corresponding to the CI for the risk difference whose LCL equals -20%.

    Primary: Proportion of subjects achieving either a 2 g/dL increase in Hb or normalisation of Hb (>=12 g/dL women, >=13 g/dL men) at Week 12 - ITT

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    End point title
    		 Proportion of subjects achieving either a 2 g/dL increase in Hb or normalisation of Hb (>=12 g/dL women, >=13 g/dL men) at Week 12 - ITT
    End point description
    The primary efficacy endpoint was the proportion of subjects achieving either a 2 g/dL increase in Hb or normalisation of Hb (>=12 g/dL women, >=13 g/dL men) at Week 12 in ITT (MI) population
    End point type
    Primary
    End point timeframe
    12 weeks (primary efficacy endpoint of study)
    End point values
    		 Ferric Maltol IV Iron ITT population
    Number of subjects analysed
    125
    125
    250
    Units: Subjects
        Responder
    84
    105
    189
        Non-responder
    41
    20
    61
    Statistical analysis title
    		 Statistical testing Hb responder rate at 12 weeks
    Statistical analysis description
    ITT (MI)
    Comparison groups
    Ferric Maltol v IV Iron
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.298
    Method
    		 t-test, 2-sided
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 -0.06
    Variability estimate
    Standard deviation
    Notes
    [2] - The null hypothesis for the primary efficacy analysis will be rejected (i.e., ferric maltol will be deemed non-inferior to IV Iron), if the LCL of the 95% CI for the difference (ferric maltol – IV Iron) in proportions of Hb responders at Week 12 is ≥ -20% for both the ITT analysis and the re-evaluated PP analysis. The p-value in testing the aforementioned hypotheses will be equal to one minus the confidence coefficient corresponding to the CI for the risk difference whose LCL equals -20%.

    Secondary: Change from Baseline in Haemoglobin Concentration Over 12 weeks

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    End point title
    		 Change from Baseline in Haemoglobin Concentration Over 12 weeks
    End point description
    The key secondary efficacy endpoint was change from baseline in Hb concentration at Week 12. The change from baseline in Hb concentration was analysed using an ANCOVA model adjusted for treatment group, baseline Hb, and IBD subgroup and was based on ITT(MI).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: g/dL
        arithmetic mean (standard deviation)
    2.45 ± 1.449
    3.04 ± 1.576
    No statistical analyses for this end point

    Secondary: Change in Hb concentration from baseline to Week 4

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    End point title
    		 Change in Hb concentration from baseline to Week 4
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    117
    117
    Units: g/dL
        arithmetic mean (standard deviation)
    1.27 ± 0.974
    2.19 ± 1.133
    No statistical analyses for this end point

    Secondary: Change in Hb concentration from baseline to Week 4 in subjects with baseline Hb <9.5 g/dL

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    End point title
    		 Change in Hb concentration from baseline to Week 4 in subjects with baseline Hb <9.5 g/dL
    End point description
    Change in Hb concentration from baseline to Week 4 in subjects with a baseline Hb <9.5 g/dL - ITT (MI) population
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    36
    33
    Units: g/dL
        arithmetic mean (standard deviation)
    1.35 ± 0.993
    2.99 ± 1.092
    No statistical analyses for this end point

    Secondary: Change in Hb concentration from baseline at Week 12 in subjects with baseline Hb <9.5 g/dL

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    End point title
    		 Change in Hb concentration from baseline at Week 12 in subjects with baseline Hb <9.5 g/dL
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: g/dL
        arithmetic mean (standard deviation)
    2.83 ± 1.493
    4.18 ± 1.686
    No statistical analyses for this end point

    Secondary: Proportion of subjects who experience a change from baseline (CFB) in Hb concentration ≥1.0 g/dL at Week 12

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    End point title
    		 Proportion of subjects who experience a change from baseline (CFB) in Hb concentration ≥1.0 g/dL at Week 12
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: Subjects
        Responder
    107
    111
        Non-responder
    18
    14
    No statistical analyses for this end point

    Secondary: Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥1 g/dL at Week 12

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    End point title
    		 Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥1 g/dL at Week 12
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: Subjects
        Responder
    35
    32
        Non-responder
    3
    3
    No statistical analyses for this end point

    Secondary: Proportion of subjects who experience a CFB in Hb concentration ≥2.0 g/dL at Week 12

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    End point title
    		 Proportion of subjects who experience a CFB in Hb concentration ≥2.0 g/dL at Week 12
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: Subjects
        Responder
    76
    96
        Non-responder
    49
    29
    No statistical analyses for this end point

    Secondary: Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥2 g/dL at Week 12

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    End point title
    		 Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥2 g/dL at Week 12
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: Subjects
        Responder
    26
    30
        Non-responder
    12
    5
    No statistical analyses for this end point

    Secondary: Proportion of subjects who experience a CFB in Hb concentration ≥1.0 g/dL at Week 4

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    End point title
    		 Proportion of subjects who experience a CFB in Hb concentration ≥1.0 g/dL at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: Subjects
        Responder
    75
    105
        Non-responder
    50
    20
    No statistical analyses for this end point

    Secondary: Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥1 g/dL at Week 4

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    End point title
    		 Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥1 g/dL at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: Subjects
        Responder
    23
    33
        Non-responder
    15
    2
    No statistical analyses for this end point

    Secondary: Proportion of subjects who experience a CFB in Hb concentration ≥2.0 g/dL at Week 4

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    End point title
    		 Proportion of subjects who experience a CFB in Hb concentration ≥2.0 g/dL at Week 4
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: Subjects
        Responder
    26
    75
        Non-responder
    99
    50
    No statistical analyses for this end point

    Secondary: Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥2 g/dL at Week 4

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    End point title
    		 Proportion of subjects with baseline Hb <9.5 g/dL that achieve an increase in Hb concentration of ≥2 g/dL at Week 4
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: Subjects
        Responder
    5
    28
        Non-responder
    33
    7
    No statistical analyses for this end point

    Secondary: Proportion of subjects with Hb concentration within normal limits at Week 12

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    End point title
    		 Proportion of subjects with Hb concentration within normal limits at Week 12
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: Subjects
        Responder
    69
    101
        Non-responder
    56
    24
    No statistical analyses for this end point

    Secondary: Proportion of subjects with baseline Hb concentration <9.5 g/dL that is within normal limits at Week 12

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    End point title
    		 Proportion of subjects with baseline Hb concentration <9.5 g/dL that is within normal limits at Week 12
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: Subjects
        Responder
    12
    28
        Non-responder
    26
    7
    No statistical analyses for this end point

    Secondary: Proportion of subjects with Hb concentration within normal limits at Week 4

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    End point title
    		 Proportion of subjects with Hb concentration within normal limits at Week 4
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    125
    Units: Subjects
        Responder
    31
    60
        Non-responder
    94
    65
    No statistical analyses for this end point

    Secondary: Proportion of subjects with baseline Hb concentration <9.5 g/dL that is within normal limits at Week 4

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    End point title
    		 Proportion of subjects with baseline Hb concentration <9.5 g/dL that is within normal limits at Week 4
    End point description
    ITT (MI)
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    38
    35
    Units: Subjects
        Responder
    2
    15
        Non-responder
    36
    20
    No statistical analyses for this end point

    Secondary: Change in ferritin concentration from baseline to Week 12

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    End point title
    		 Change in ferritin concentration from baseline to Week 12
    End point description
    ITT (OC)
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    106
    112
    Units: ng/ml
        arithmetic mean (standard deviation)
    16.15 ± 21.721
    129.64 ± 170.154
    No statistical analyses for this end point

    Other pre-specified: Long term efficacy endpoints, Anaemic status at Week 24

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    End point title
    		 Long term efficacy endpoints, Anaemic status at Week 24
    End point description
    Number of subjects with non-anaemic status at week 24 in population ITT (OC)
    End point type
    Other pre-specified
    End point timeframe
    At week 24
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    80
    85
    Units: Subjects
        anamic
    28
    27
        non-anaemic
    52
    58
    No statistical analyses for this end point

    Other pre-specified: Long term efficacy endpoint, normal ferritin levels at Week 24

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    End point title
    		 Long term efficacy endpoint, normal ferritin levels at Week 24
    End point description
    ITT (OC)
    End point type
    Other pre-specified
    End point timeframe
    At week 24
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    77
    86
    Units: Subjects
        responder
    56
    60
        non-responder
    21
    26
    No statistical analyses for this end point

    Other pre-specified: Quality of life - Medical outcome study SF-36

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    End point title
    		 Quality of life - Medical outcome study SF-36
    End point description
    Changes from baseline in physical component (PCS) and mental component (MCS) for SF-36 questionnaires. Data is from the last observation carried forward
    End point type
    Other pre-specified
    End point timeframe
    At week 12
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    125
    124
    Units: Score
    arithmetic mean (standard deviation)
        PCS - week 12
    3.4 ± 6.04
    2.3 ± 6.34
        PCS - week 24
    3.6 ± 6.86
    2.7 ± 6.75
        PCS - week 36
    3.3 ± 7.43
    2.5 ± 6.78
        PCS week 52/ET
    3.0 ± 7.62
    2.5 ± 7.52
        MCS - week 12
    3.8 ± 6.69
    2.6 ± 6.65
        MCS - week 24
    4.1 ± 7.85
    3.1 ± 6.86
        MCS - week 36
    3.6 ± 8.19
    3.0 ± 7.04
        MCS - week 52/ET
    3.3 ± 8.32
    2.6 ± 7.60
    No statistical analyses for this end point

    Other pre-specified: Long-term efficacy endpoint, anaemic status at Week 36

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    End point title
    		 Long-term efficacy endpoint, anaemic status at Week 36
    End point description
    ITT (OC)
    End point type
    Other pre-specified
    End point timeframe
    Week 36
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    55
    62
    Units: subjects
        anaemic
    16
    15
        non-anaemic
    39
    47
    No statistical analyses for this end point

    Other pre-specified: Long-term efficacy endpoint, anaemic status at Week 52/ET

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    End point title
    		 Long-term efficacy endpoint, anaemic status at Week 52/ET
    End point description
    ITT (OC)
    End point type
    Other pre-specified
    End point timeframe
    Week 52/Early Termination
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    61
    56
    Units: subjects
        anaemic
    24
    20
        non-anaemic
    37
    36
    No statistical analyses for this end point

    Other pre-specified: Long term efficacy endpoint, normal ferritin levels at Week 36

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    End point title
    		 Long term efficacy endpoint, normal ferritin levels at Week 36
    End point description
    ITT (OC)
    End point type
    Other pre-specified
    End point timeframe
    Week 36
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    54
    62
    Units: subjects
        responder
    43
    37
        non-responder
    11
    25
    No statistical analyses for this end point

    Other pre-specified: Long term efficacy endpoint, normal ferritin levels at Week 52/ET

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    End point title
    		 Long term efficacy endpoint, normal ferritin levels at Week 52/ET
    End point description
    ITT (OC)
    End point type
    Other pre-specified
    End point timeframe
    At Week 52/Early Termination
    End point values
    		 Ferric Maltol IV Iron
    Number of subjects analysed
    58
    56
    Units: subjects
        responder
    39
    39
        non-responder
    19
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Ferric maltol - Safety data set
    Reporting group description
    		 Treatment Emergent Adverse Events (TEAEs) reported in the treatment arm with Ferric Maltol

    Reporting group title
    IV Iron - Safety dataset
    Reporting group description
    		 Treatment Emergent Adverse Events (TEAEs) reported in the treatment arm with IV Ironl

    Serious adverse events
    		 Ferric maltol - Safety data set IV Iron - Safety dataset
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 127 (9.45%)
    4 / 120 (3.33%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Superficial spreading melanoma stage unspecified
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic stenosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Purpura non-thrombocytopenic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mania
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Ferric maltol - Safety data set IV Iron - Safety dataset
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 127 (49.61%)
    39 / 120 (32.50%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 120 (0.83%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 120 (0.83%)
         occurrences all number
    4
    1
    Migraine
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 120 (0.00%)
         occurrences all number
    4
    0
    Dizziness
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0
    Presyncope
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 120 (1.67%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 127 (0.79%)
    4 / 120 (3.33%)
         occurrences all number
    1
    4
    Asthenia
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 120 (0.83%)
         occurrences all number
    3
    1
    Chest pain
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 120 (1.67%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 120 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    12 / 127 (9.45%)
    3 / 120 (2.50%)
         occurrences all number
    13
    3
    Nausea
         subjects affected / exposed
    6 / 127 (4.72%)
    2 / 120 (1.67%)
         occurrences all number
    8
    5
    Abdominal pain upper
         subjects affected / exposed
    7 / 127 (5.51%)
    2 / 120 (1.67%)
         occurrences all number
    7
    2
    Colitis ulcerative
         subjects affected / exposed
    4 / 127 (3.15%)
    4 / 120 (3.33%)
         occurrences all number
    4
    4
    Crohn's disease
         subjects affected / exposed
    3 / 127 (2.36%)
    4 / 120 (3.33%)
         occurrences all number
    3
    5
    Constipation
         subjects affected / exposed
    5 / 127 (3.94%)
    1 / 120 (0.83%)
         occurrences all number
    5
    2
    Diarrhoea
         subjects affected / exposed
    6 / 127 (4.72%)
    1 / 120 (0.83%)
         occurrences all number
    6
    1
    Faeces discoloured
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 120 (0.00%)
         occurrences all number
    4
    0
    Flatulence
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 120 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 120 (2.50%)
         occurrences all number
    1
    3
    Abdominal distension
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 120 (0.00%)
         occurrences all number
    3
    0
    Mouth ulceration
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 120 (0.83%)
         occurrences all number
    2
    1
    Alopecia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 120 (0.83%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 120 (0.83%)
         occurrences all number
    4
    1
    Back pain
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 120 (0.83%)
         occurrences all number
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 127 (7.87%)
    4 / 120 (3.33%)
         occurrences all number
    11
    6
    Cellulitis
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 120 (0.00%)
         occurrences all number
    4
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 120 (2.50%)
         occurrences all number
    1
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 120 (1.67%)
         occurrences all number
    2
    2
    Clostridium difficile infection
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 120 (1.67%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 120 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 120 (0.83%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 120 (0.83%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 120 (1.67%)
         occurrences all number
    1
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 120 (0.83%)
         occurrences all number
    2
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 120 (0.83%)
         occurrences all number
    1
    1
    Herpes zoster
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2015
    Global Amendment 1 (protocol version 3.0). MAJOR CHANGES: 1. Addition of secondary endpoints to give specific information on the efficacy in population with baseline Hb concentration < 9.5g/dL. 2. Update to Primary objective wording to include only subjects with IBD in whom other oral iron therapies have failed. 3. Changes to inclusion criteria, to include subjects with Hb >= 8.0 g/dL and Ferritin <30 ng/ml or Ferritin <100 ng/ml an to clarify the wording for female with childbearing potential. 4. Changes to exclusion criteria, to clarify the permitted use of some immunosuppressant; to exclude patient who received oral iron supplementation within 4 weeks, to broaden the IBD population by changing the SCCAI and CDAI score for exclusion; to clarify exclusion for allergy sufferers; to only exclude patients with serious adverse reactions with IV iron from the trial. 5. Changes to concomitant medications to clarify the permitted use of immunosuppressant. 6. Addition of advice regarding ptential ferric maltol drug interactions. 7. Changes to individual discontinuation criteria, to discontinue patients from the study in case of use of prohibited co-medications, blood transfusions, change in immunosuppressant route. 8. Changes to the non-inferiority margin to 20% and the power of the study to 90%. this increased the number of required subjects to 108 per arm (121 to allow for protocol deviations). Various minor / administrative changes.
    08 Jul 2016
    Global Amendment 2 (protocol version 4.0). MAJOR CHANGES. 1. Addition of secondary endpoints related to Hb concentration at week 4. 2. Change to primary objective to clarify the population also includes patients for whom other oral iron therapies are not considered suitable. 3. Expansion of the study to US as well as in the EU. Various minor / administrative changes to reflect the change of the name of the sponsor (from Iron therapeutics to Shield TX, legal entity remains the same) and include background to reflect the extension of the study to the US.
    04 Jan 2017
    Global Amendment 3 (protocol version 5.0). MAJOR CHANGES. 1 and 2. Change in primary objective and inclusion criteria to include OFP-naive patients, and not only following OFP failure or unsuitability. 3. Small widening of the iron deficiency anaemia definition from <11 or 12 g/dL to <= 11 or 12 g/dL. 4 and 16. Clarification of permitted changes in the immunosuppressnt co-medication. 5. Clarification to refer to ferric carboxymaltose as intravenous iron in the exclusion criteria to ensure consistency for all countries. 6. Vitamin B12 or folic acid deficiency definition as an exclusion criteria is to be determined by the central laboratory screening results only and no longer by the investigator. 7. the exclusion criteria regarding subject with severe renal impairment is mentioned as applicable to US sites only. 8. Change to the discontinuation criteria for TSAT to above 60%, as it happens in the study population and is not indicative of iron overload. 9 to 15. Change in the dosing requirement of ferric maltol to clarify timing of administration of concomitant medication and introducing a 8-hour gap between doses. This change is implemented at each visit for compliance check and as a dosing reminder for patients. 11. and 15. Patients will be given 3 bottles of study drug (instead of 4) at visit 2 (randomisation) that will cover the 12 weeks of treatment before the next visit, and 4 bottles at visit 5 (week 36) that will cover for the final 16 weeks of treatment. Patients will be reminded at each visit that the number of bottle they are given (3 or 4) are sufficient for the treatment until the next visit. 17. Secondary endpoints regarding increase of Hb concentration of 1g/dL and 2g/dL have been split into two separate endpoints. Various minor / administrative changes, including an update to the number of sites in US and EU.
    11 Jul 2017
    Global Amendment 4 (protocol version 6.0). MAJOR CHANGES. 1, 2 and 6. Change in the exclusion criteria to allow dose change in immunosuppressant co-medication. This would reflect the current practice and also help to address low recruitment rates. 3. dosing information added in the previous amendment have been added to the section regarding interaction for consistency. 4. Changes in the discontinuation criteria to clarify the definition of transient rise or TSAT or ferritin and to allow immunosuppressent dose change as per amended exclusion criteria (see 1.). 5. Administration of IV iron at week 4 should only be done if clinically required. Various minor / administrative changes to correct spelling.
    30 Apr 2018
    Global amendment 5 (Protocol v7.0). MAJOR CHANGES. The study duration change from 52 weeks to 12 weeks (for new patients, existing patients will continue until their next scheduled visit) in an effort to improve recruitment rate. this change is reflected in various sections of the protocol: study design (5.4.3), dose selection (5.5), discontinuation criteria (7.4.6), IMP (8.1), clinical laboratory (10.2.12). The schedule of assessment for visit 4 and after have been revised in line with the amended study duration (patient's next visit after visit 4 will be the end of treatment visit). Various minor / administrative changes for consistency with protocol changes.

    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
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