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    Clinical Trial Results:
    Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study

    Summary
    EudraCT number
    		 2017-000330-61
    Trial protocol
    		 ES  
    Global end of trial date
    01 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2022
    First version publication date
    19 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CHI-DIP-2016-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Chiesi España S.A.U.
    Sponsor organisation address
    Torre Realia BCN - Plaça d'Europa, 41-43, planta 10, Barcelona, Spain, 08908
    Public contact
    Chiesi España, Chiesi España S.A.U., 0034 934 94 80 00,
    Scientific contact
    Medical Advisor - Special Care, Marta López Sanromà , 0034 934 948 000,
    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
    15 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the superiority of oral BDP over placebo in reducing FCP levels below 100 μg/g after 4 weeks of treatment in patients with clinical remission and at risk of relapse* who are receiving 5-ASA therapy.)
    Protection of trial subjects
    This clinical trial was conducted in accordance with the protocol, the principles established in the revised version of the Declaration of Helsinki regarding medical research in humans (64 General Assembly, Fortaleza, Brazil, 2013), and the Harmonized Tripartite Guidelines of the International Conference on Harmonisation (ICH) for Good Clinical Practice 1996. Likewise, it was carried out in accordance with the applicable regulatory requirements, in particular Royal Decree 1090/2015 and Regulation (EU) 536/2014, regulating clinical trials with medicinal products in Spain and the European Union, respectively, and Law 14/2007, on biomedical research. The study started once approval was available from the CREC, as well as from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS). Each patient invited to participate in the study was given a written document called the “Patient Information Sheet”, which contained the relevant and necessary information about the nature of the study, its objectives and procedures, the potential benefits and risks for the patient, as well as the guarantee of personal data protection. This document reflected the voluntary nature of patient participation in the study, and fully and unequivocally indicated the possibility of refusing to participate and of withdrawing consent at any time and for any reason, without having to justify the decision, and without the decision affecting his/her subsequent medical treatment and follow-up, or his/her relationship with the treating physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2017
    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: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    37
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 91 patients recruited from 12 Spanish sites since 15 July 2017

    Pre-assignment
    Screening details
    		 Patients with 18 years old diagnosed with left-side or extended ulcerative colitis at least one year before, in clinical remission at the screening visit, with central laboratory confirmed FCP levels > 250 ug/g and treated with 5-ASA for at least 4 weeks prior to the screening visit. Patients without presence of a stoma or prior colon resection.

    Period 1
    Period 1 title
    Part I
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients were treated for 4 weeks with 5 mg/day of BDP orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Beclomethasone dipropionate (BDP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BDP dose is 5 mg/day and it was administrated orally.

    Arm title
    		 Group B
    Arm description
    		 Patients will be treated for 4 weeks with placebo orally.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo dose is 5 mg/day and was administrated orally.

    Number of subjects in period 1
    		Group A Group B
    Started
    22
    21
    Completed
    22
    17
    Not completed
    0
    4
         premature withdrawal
    -
    4
    Period 2
    Period 2 title
    Part II
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Single arm (group A)
    Arm description
    		 During part II, patients were also treated for 4 weeks with 5 mg/day of BDP, administered orally. Patients with fecal calprotectin values > 100 ug/g after 4 weeks of treatment who came from group A of part I (BDP treated) of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Beclomethasone dipropionate (BDP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BDP dose is 5 mg/day and it was administrated orally.

    Arm title
    		 Single arm (group B)
    Arm description
    		 During part II, patients were also treated for 4 weeks with 5 mg/day of BDP, administered orally. Patients with fecal calprotectin values > 100 ug/g after 4 weeks of treatment who came from group B of part I (placebo treated) of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Beclomethasone dipropionate (BDP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BDP dose is 5 mg/day and it was administrated orally.

    Number of subjects in period 2 [1]
    		Single arm (group A) Single arm (group B)
    Started
    9
    14
    Completed
    9
    14
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: According to the protocol, 16 patients obtained fecal calprotectin values < 100 ug/g after 4 weeks of treatment and therefore completed the study and did not initiate part II.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients were treated for 4 weeks with 5 mg/day of BDP orally.

    Reporting group title
    Group B
    Reporting group description
    		 Patients will be treated for 4 weeks with placebo orally.

    Reporting group values
    		 Group A Group B Total
    Number of subjects
    		 22 21 43
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.6 ( 12.4 ) 48.4 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 7 13
        Male
    		 16 14 30
    Cormobilities
    Patients may have more than one cormobility at the same time.
    Units: Subjects
        Infectious disease
    		 1 0 1
        Cardiovascular disease
    		 1 3 4
        Musculoskeletal disorders
    		 0 1 1
        Gastrointestinal disorder
    		 1 3 4
        Neurological/psychiatric disorder
    		 3 1 4
        Haematological disorder
    		 1 0 1
        Respiratory disease
    		 1 2 3
        Renal impairment
    		 0 1 1
        Endocrine disorder
    		 1 3 4
        Other comorbidities
    		 3 4 7
        None
    		 10 3 13
    Extent of ulcerative colitis
    Units: Subjects
        Left side
    		 7 16 23
        Extensive
    		 15 5 20
    Number of patients currently being treated for ulcerative colitis
    Units: Subjects
        No
    		 0 0 0
        Yes
    		 22 21 43
    Number of patients who received oral 5-ASA
    Units: Subjects
        No
    		 0 2 2
        Yes
    		 22 19 41
    Number of patients who received topical 5-ASA
    Units: Subjects
        No
    		 8 13 21
        Yes
    		 14 8 22
    Number of patients who received oral corticosteroids
    Units: Subjects
        No
    		 14 11 25
        Yes
    		 8 9 17
        Unknown
    		 0 1 1
    Number of patients who received azathioprine
    Units: Subjects
        No
    		 19 18 37
        Yes
    		 3 2 5
        Unknown
    		 0 1 1
    Partial Mayo Score, Item 1. Stool frequency
    Units: Subjects
        Normal
    		 19 17 36
        1-2 more than usual
    		 3 4 7
    Partial Mayor Score, Item 2. Rectal bleeding
    Units: Subjects
        No
    		 22 21 43
        Yes
    		 0 0 0
    Partial Mayo Score, Item 3. Physician’s global assessment
    Units: Subjects
        Normal
    		 19 19 38
        Mild disease
    		 3 2 5
    Time from diagnosis of ulcerative colitis
    Units: years
        arithmetic mean (standard deviation)
    		 10.6 ( 8.6 ) 7.6 ( 8.7 ) -
    Time from last relapse to signing of informed consent
    Units: years
        arithmetic mean (standard deviation)
    		 1.7 ( 1.7 ) 1.7 ( 2.1 ) -
    Time from last colonoscopy to signing of informed consent
    Units: Years
        arithmetic mean (standard deviation)
    		 2.0 ( 1.9 ) 1.2 ( 1.8 ) -
    Number of relapses in the last two years
    Units: Years
        arithmetic mean (standard deviation)
    		 1.0 ( 0.8 ) 1.2 ( 0.4 ) -
    Faecal calprotectin in last 60 days
    Units: mg/kg
        arithmetic mean (standard deviation)
    		 899.9 ( 699.0 ) 1255.5 ( 788.1 ) -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 133.2 ( 21.1 ) 130.6 ( 17.9 ) -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 83.2 ( 11.3 ) 76.5 ( 9.8 ) -
    Pulse
    Units: Pulse/ min
        arithmetic mean (standard deviation)
    		 80.6 ( 14.6 ) 72.0 ( 10.9 ) -
    Mean Partial Mayo Score
    Units: score
        arithmetic mean (standard deviation)
    		 0.3 ( 0.6 ) 0.3 ( 0.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients were treated for 4 weeks with 5 mg/day of BDP orally.

    Reporting group title
    Group B
    Reporting group description
    		 Patients will be treated for 4 weeks with placebo orally.
    Reporting group title
    Single arm (group A)
    Reporting group description
    		 During part II, patients were also treated for 4 weeks with 5 mg/day of BDP, administered orally. Patients with fecal calprotectin values > 100 ug/g after 4 weeks of treatment who came from group A of part I (BDP treated) of the study.

    Reporting group title
    Single arm (group B)
    Reporting group description
    		 During part II, patients were also treated for 4 weeks with 5 mg/day of BDP, administered orally. Patients with fecal calprotectin values > 100 ug/g after 4 weeks of treatment who came from group B of part I (placebo treated) of the study.

    Primary: Patients with FCP levels < 100 μg/g after 4 weeks

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    End point title
    		 Patients with FCP levels < 100 μg/g after 4 weeks
    End point description
    To evaluate the superiority of oral BDP over placebo in reducing FCP levels below 100 μg/g after 4 weeks of treatment in patients with clinical remission and at risk of relapse* who are receiving 5-ASA therapy.
    End point type
    Primary
    End point timeframe
    After 4 weeks of treatment (at week 5)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [1]
    Units: patients
    13
    3
    Notes
    [1] - 4 patients were prematurely withdrawn
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Fisher exact
    Confidence interval

    Primary: FCP values at week 5

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    End point title
    		 FCP values at week 5
    End point description
    To evaluate the superiority of oral BDP over placebo in reducing FCP levels below 100 μg/g after 4 weeks of treatment in patients with clinical remission and at risk of relapse* who are receiving 5-ASA therapy.
    End point type
    Primary
    End point timeframe
    After 4 weeks of treatment (at week 5)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [2]
    Units: ug/g
        arithmetic mean (standard deviation)
    150 ( 158 )
    512 ( 497 )
    Notes
    [2] - 4 patients were prematurely withdrawn
    Statistical analysis title
    		 Wilcoxon rank-sum test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Patients with FCP levels < 100 μg/g after 8 weeks

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    End point title
    		 Patients with FCP levels < 100 μg/g after 8 weeks
    End point description
    To evaluate the effect of oral BDP on the reduction of FCP levels to below 100 μg/g after 8 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (at week 9)
    End point values
    		 Single arm (group A) Single arm (group B)
    Number of subjects analysed
    8 [3]
    13 [4]
    Units: patients
    2
    5
    Notes
    [3] - One missing data
    [4] - One missing data
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Single arm (group A) v Single arm (group B)
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.656
    Method
    		 Fisher exact
    Confidence interval

    Secondary: FCP values at week 9

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    End point title
    		 FCP values at week 9
    End point description
    To evaluate the effect of oral BDP on the reduction of FCP levels to below 100 μg/g after 8 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (week 9)
    End point values
    		 Single arm (group A) Single arm (group B)
    Number of subjects analysed
    8
    13
    Units: ug/g
        arithmetic mean (standard deviation)
    426 ( 501 )
    214 ( 212 )
    Statistical analysis title
    		 Wilcoxon rank-sum test
    Comparison groups
    Single arm (group A) v Single arm (group B)
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.491
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: FCP values at week 9 (LOFCP)

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    End point title
    		 FCP values at week 9 (LOFCP)
    End point description
    To evaluate the effect of oral BDP on the reduction of FCP levels to below 100 μg/g after 8 weeks of treatment. Data referred to the last observation of FCP (LOFCP) values for each patient.
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (at week 9)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [5]
    Units: ug/g
        arithmetic mean (standard deviation)
    195 ( 344 )
    244 ( 318 )
    Notes
    [5] - 4 patients were prematurely withdrawal
    Statistical analysis title
    		 Wilcoxon rank-sum test
    Comparison groups
    Group B v Group A
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.327
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Patients with FCP levels < 100 μg/g after 8 weeks (LOFCP)

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    End point title
    		 Patients with FCP levels < 100 μg/g after 8 weeks (LOFCP)
    End point description
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (at week 9)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [6]
    Units: patients
    15
    8
    Notes
    [6] - 4 patients prematurely withdrawn
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Group B v Group A
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.209
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Patients with FCP levels < 150 μg/g after 4 weeks

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    End point title
    		 Patients with FCP levels < 150 μg/g after 4 weeks
    End point description
    Effect of BPD in reducing FCP levels below 150 µg/g versus placebo.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatment (week 5)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [7]
    Units: patients
    14
    4
    Notes
    [7] - 4 patients prematurely withdrawn
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Patients with FCP levels < 150 μg/g after 8 weeks

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    End point title
    		 Patients with FCP levels < 150 μg/g after 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (week 9)
    End point values
    		 Single arm (group A) Single arm (group B)
    Number of subjects analysed
    8 [8]
    13 [9]
    Units: patients
    3
    6
    Notes
    [8] - One missing data
    [9] - One missing data
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Single arm (group A) v Single arm (group B)
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Patients with FCP levels < 150 μg/g after 8 weeks (LOFCP)

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    End point title
    		 Patients with FCP levels < 150 μg/g after 8 weeks (LOFCP)
    End point description
    Data referred to the last observation of FCP (LOFCP) values for each patient
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (week 9)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17
    Units: patients
    16
    9
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.314
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Patients with FCP levels < 50 μg/g after 4 weeks

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    End point title
    		 Patients with FCP levels < 50 μg/g after 4 weeks
    End point description
    Effect of BPD in reducing FCP levels to below 50µg/g versus placebo was studied.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatment (week 5)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [10]
    Units: patients
    6
    2
    Notes
    [10] - 4 patients prematurely withdrawn
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.426
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Patients with FCP levels < 50 μg/g after 8 weeks

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    End point title
    		 Patients with FCP levels < 50 μg/g after 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (week 9)
    End point values
    		 Single arm (group A) Single arm (group B)
    Number of subjects analysed
    8 [11]
    13 [12]
    Units: patients
    1
    3
    Notes
    [11] - One missing data
    [12] - One missing data
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Single arm (group B) v Single arm (group A)
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Patients with FCP levels < 50 μg/g after 8 weeks (LOFCP)

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    End point title
    		 Patients with FCP levels < 50 μg/g after 8 weeks (LOFCP)
    End point description
    Data referred to the last observation of FCP (LOFCP) values for each patient
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment (week 9)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17
    Units: patients
    7
    5
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Fisher exact
    Confidence interval

    Secondary: FCP reduction

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    End point title
    		 FCP reduction
    End point description
    Differences between treatment groups in FCP reduction between week 5 and baseline and between week 9 and baseline. Na and Nb are the number of patients analyse in groups A and B, respectively.
    End point type
    Secondary
    End point timeframe
    Different timepoints
    End point values
    		 Group A Group B
    Number of subjects analysed
    22 [13]
    17 [14]
    Units: ug/g
    arithmetic mean (standard deviation)
        W5-baseline (Na=22; Nb=17)
    472 ( 396 )
    119 ( 505 )
        W9-baseline (Na=8; Nb=13)
    168 ( 512 )
    497 ( 420 )
        W9-baseline (LOFCP) (Na=22; Nb=17)
    426 ( 499 )
    387 ( 468 )
    Notes
    [13] - Na y Nb indicates number of patients analyse in group A and group B, respectively.
    [14] - Na y Nb indicates number of patients analyse in group A and group B, respectively.
    Statistical analysis title
    		 Wilcoxon rank-sum test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Partial Mayo Score at week 5

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    End point title
    		 Partial Mayo Score at week 5
    End point description
    Categorised score (< 4 and ≥ 4 points) obtained from the Partial Mayo Score after 5 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatment
    End point values
    		 Group A Group B
    Number of subjects analysed
    22
    17 [15]
    Units: patients
        < 4
    22
    17
        ≥ 4
    0
    0
    Notes
    [15] - 4 patients prematurely withdrawn
    No statistical analyses for this end point

    Secondary: Partial Mayo Score at week 9

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    End point title
    		 Partial Mayo Score at week 9
    End point description
    Categorised score (< 4 and ≥ 4 points) obtained from the Partial Mayo Score after 9 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment
    End point values
    		 Single arm (group A) Single arm (group B)
    Number of subjects analysed
    9
    13 [16]
    Units: patients
        < 4
    9
    13
        ≥ 4
    0
    0
    Notes
    [16] - One missing data
    No statistical analyses for this end point

    Secondary: Partial Mayo Score at week 16 or 21

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    End point title
    		 Partial Mayo Score at week 16 or 21
    End point description
    Categorised score (< 4 and ≥ 4 points) obtained from the Partial Mayo Score 3 months after the end of treatment (week 16 or week 21).
    End point type
    Secondary
    End point timeframe
    3 month after the end of treatment
    End point values
    		 Group A Group B
    Number of subjects analysed
    21
    15
    Units: patients
        < 4
    20
    15
        ≥ 4
    1
    0
    No statistical analyses for this end point

    Secondary: FCP reduction three months after the end of the treatment

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    End point title
    		 FCP reduction three months after the end of the treatment
    End point description
    Effect of BDP in modifying the FCP levels three months after the end of the treatment.
    End point type
    Secondary
    End point timeframe
    3 months after the end of the treatment (weeks 16 or 21)
    End point values
    		 Group A Group B
    Number of subjects analysed
    22 [17]
    17 [18]
    Units: ug/g
    arithmetic mean (standard deviation)
        Original population (Na=19; Nb=15)
    253 ( 588 )
    182 ( 527 )
        LOFCP population (Na=22; Nb=17)
    254 ( 591 )
    137 ( 539 )
    Notes
    [17] - Na and Nb indicates patients analysed in groups A and B respectively in each population
    [18] - Na and Nb indicates patients analysed in groups A and B respectively in each population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Parts I and II of the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Safety population: group A
    Reporting group description
    		 -

    Reporting group title
    Safety population: group B
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population: group A Safety population: group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Ulcerative gastritis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         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: 1%
    Non-serious adverse events
    		 Safety population: group A Safety population: group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 22 (31.82%)
    10 / 21 (47.62%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Influenza-like illness
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Ulcerative colitis
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Toothache
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Common cold
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Cough
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2017
    Extension of 3 months in the follow-up of patients in order to assess whether the clinical benefit is maintained over time, as well as to determine disease relapses (if any).
    12 Feb 2018
    In order to facilitate patient recruitment, the decision is made to: - Remove inclusion criterion 4. - Extend the time period between Visits 1 and 2, adjusting more realistically to the times required to obtain the results of the FCP test. - Modify inclusion criterion 5 by extending the time period in which an available FCP value is required in the patient clinical history to 60 days.
    19 Nov 2018
    Addition of 4 sites: - Hospital Universitario Josep Trueta de Girona - Complejo Hospitalario de Ferrol - Hospital Clínico Universitario de Valencia - Hospital Parc Taulí
    03 Mar 2020
    The following modifications are made to facilitate recruitment and to better adapt to clinical practice at the sites: - Only the FCP levels of the central laboratory are considered. - Patients receiving thiopurines (azathioprine and mercaptopurine) are accepted. - Addition of sites. In addition, corrections of errata and administrative changes are made

    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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