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    Clinical Trial Results:
    Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis

    Summary
    EudraCT number
    		 2019-003334-16
    Trial protocol
    		 DE   BG   LV  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2025
    First version publication date
    12 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BUS-5/UCA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstr. 5, Freiburg, Germany,
    Public contact
    Dept. of Clinical R&D, Dr. Falk Pharma GmbH, +49 7611514140, zentrale@drfalkpharma.de
    Scientific contact
    Dept. of Clinical R&D, Dr. Falk Pharma GmbH, +49 7611514140, zentrale@drfalkpharma.de
    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
    08 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To prove the superiority of combined treatment of oral mesalazine and novel budesonide suppositories vs. oral mesalazine monotherapy in regard to early response after 4 weeks of treatment in patients with acute ulcerative colitis (UC).
    Protection of trial subjects
    Close supervision of patients by regular intermin visits, safety and wellbeing guarantied. Patient documents e.g. ICF - according to Declaration of Helsinki, ICH-GCP, local laws/regulations - submitted to ECs and approved prior to recruiting any patient. Upfront enrollent of a patient he/she a) was well informed about the trial, b) consented to participate in writing, c) and therefore, participation in trial was voluntary. Withdrawal of study always given without fear about loss of medical care. Patient consented to follow the instructions of the protocol/study team.
    Background therapy
    		 None
    Evidence for comparator
    		 Placebo suppository
    Actual start date of recruitment
    12 Apr 2021
    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
    Poland: 43
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Ukraine: 11
    Worldwide total number of subjects
    69
    EEA total number of subjects
    44
    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)
    66
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total, 99 patients were screened for the trial in 23 trial sites in four countries with eight active sites in Russia, six active sites in Ukraine, one active site in Bulgaria, and eight active sites in Poland. The first patient was enrolled on the 12th April 2021 and the last patient completed the study on the 10th February 2023.

    Pre-assignment
    Screening details
    		 Screening criteria: •Signed informed consent •man or woman between 18 and 75 years of age •Acute ulcerative colitis. Due to the armed conflict between Russia and Ukraine the recruitment of the trial had to be stopped in these countries in March 2022 and in November 2022 for the whole trial. 99 subjects were screened and 69 of them were randomized.

    Period 1
    Period 1 title
    Treatment Phase (overall trial) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 combined treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    4 mg once daily at bedtime

    Investigational medicinal product name
    Mesalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    3g once daily in the morning

    Arm title
    		 mono treatment
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Budesonide Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    once daily at bedtime

    Investigational medicinal product name
    Mesalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    3g once daily in the morning

    Number of subjects in period 1
    		combined treatment mono treatment
    Started
    34
    35
    Completed
    30
    33
    Not completed
    4
    2
         Consent withdrawn by subject
    -
    1
         lack of patients cooperation
    1
    -
         delayed exclusion
    3
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    combined treatment
    Reporting group description
    		 -

    Reporting group title
    mono treatment
    Reporting group description
    		 -

    Reporting group values
    		 combined treatment mono treatment Total
    Number of subjects
    		 34 35 69
    Age categorical
    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)
    		 34 32 66
        From 65-84 years
    		 0 3 3
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.7 ( 9.5 ) 38.0 ( 13.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 15 28
        Male
    		 21 20 41

    End points

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    End points reporting groups
    Reporting group title
    combined treatment
    Reporting group description
    		 -

    Reporting group title
    mono treatment
    Reporting group description
    		 -

    Primary: Co-primary efficacy endpoint: Clinical Remission at 4 weeks

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    End point title
    		 Co-primary efficacy endpoint: Clinical Remission at 4 weeks [1]
    End point description
    0 or 1 for UC-DAI stool frequency subscore and 0 for rectal bleeding subscore
    End point type
    Primary
    End point timeframe
    4-weeks of treatment
    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: Due to the premature termination of the trial only descriptive statistics on the mITT, disregarding estimands were performed.
    End point values
    		 combined treatment mono treatment
    Number of subjects analysed
    34
    35
    Units: Patients
    19
    16
    No statistical analyses for this end point

    Primary: Co-primary efficacy endpoint: Endoscopic Remission at 4 weeks

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    End point title
    		 Co-primary efficacy endpoint: Endoscopic Remission at 4 weeks [2]
    End point description
    Modified UC-DAI subscore for mucosal appearance in the rectum assessed by Central Assessor of 0.
    End point type
    Primary
    End point timeframe
    After 4-weeks of treatment
    Notes
    [2] - 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: Due to the premature termination of the trial only descriptive statistics on the mITT, disregarding estimands were performed.
    End point values
    		 combined treatment mono treatment
    Number of subjects analysed
    34
    35
    Units: Patients
    8
    8
    No statistical analyses for this end point

    Secondary: Secondary efficacy endpoint: Clinical Remission at EOT

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    End point title
    		 Secondary efficacy endpoint: Clinical Remission at EOT
    End point description
    Modified UC-DAI subscores for stool frequency of 0 or 1 and for rectal bleeding of 0.
    End point type
    Secondary
    End point timeframe
    at the end of trial visit
    End point values
    		 combined treatment mono treatment
    Number of subjects analysed
    34
    35
    Units: Patients
    19
    19
    No statistical analyses for this end point

    Secondary: Secondary efficacy endpoint: Endoscopic Remission at EOT

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    End point title
    		 Secondary efficacy endpoint: Endoscopic Remission at EOT
    End point description
    Modified UCDAI subscore of mucosal appearance of 0
    End point type
    Secondary
    End point timeframe
    at EOT visit
    End point values
    		 combined treatment mono treatment
    Number of subjects analysed
    34
    35
    Units: Patients
    10
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were assessed at V1 (Baseline), V2,V3, V4, V5 (EOT) and V6 (FU)
    Adverse event reporting additional description
    Treatment emergent adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    combined treatment
    Reporting group description
    		 -

    Reporting group title
    mono treatment
    Reporting group description
    		 -

    Serious adverse events
    		 combined treatment mono treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 combined treatment mono treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 34 (32.35%)
    8 / 35 (22.86%)
    Investigations
    Cortisol decreased
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 34 (14.71%)
    1 / 35 (2.86%)
         occurrences all number
    7
    2
    Dizziness
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Colitis ulcerative
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    Flatulence
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    Bronchitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Aug 2020
    The Global Amendment 01 introduced necessary changes due to one objection raised by the German Competent Authority (CA), to account for necessary logistical adaptation and in order to remove several inconsistencies and/or imprecision.
    09 Nov 2020
    The Global Amendment 02 became necessary with the escalation of the COVID-19 pandemic situation and in order to take account of related objections raised by relevant Polish Competent Authority (CA).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Nov 2022
    Due to the armed conflict between Russia and Ukraine and the sanctions, the recruitment of the trial had to be stopped in Ukraine and Russia in March 2022. Subsequently, the recruitment of the whole trial was stopped in November 2022.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No confirmative testing was performed due to low power.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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