Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

    Summary
    EudraCT number
    		 2015-001022-42
    Trial protocol
    		 IT  
    Global end of trial date
    02 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions
    Summary report(s)
    		 holystone-ibd98-m-2002-synopsis

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IBD98-M-2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02196662
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Holy Stone Healthcare Co., Ltd
    Sponsor organisation address
    Neihu road, Taipei, Taiwan,
    Public contact
    Clinical Trials Information, Holy Stone Biotech Co., Ltd., +41 22 704 0545, info@hsbiotech.co.uk
    Scientific contact
    Clinical Trials Information, Holy Stone Biotech Co., Ltd., +41 22 704 0545, info@hsbiotech.co.uk
    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
    27 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the percentage of patients in UC remission at Week 6 for each of the 2 IBD98-M dose groups versus placebo (remission defined as the modified Ulcerative Colitis Disease Activity Index [UCDAI] score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1)
    Protection of trial subjects
    In case of injury or disease further to your participation in this study, you will receive appropriate medical care. The Holy Stone Healthcare is committed to cover all medical costs not covered by the provincial health plan or your private medical insurance (if any). If you suffer a serious or lasting injury as a result of participation in this study, it may affect your ability to obtain private health insurance, your employability, and/or quality of life. No compensation other than that mentioned in this Informed Consent Form will routinely be offered.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 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
    Italy: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    41
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The patients having a score of ≥ 4 and ≤ 10 on the modified UCDAI and a score of ≥ 1 on the endoscopy mucosal appearance subscore were enrolled in the study.

    Pre-assignment
    Screening details
    		 During the screening period, patients will be evaluated by conducting laboratory tests, physical examination, and sigmoidoscopy. To be eligible, patients are to have a score of ≥4 and ≤10 on the modified UCDAI, and a score of ≥1 on the modified UCDAI endoscopy subscore. In addition, the diagnosis of UC must be confirmed by endoscopic and histolog

    Pre-assignment period milestones
    Number of subjects started
    		 51
    Number of subjects completed
    		 51

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    double dummy techniques

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High dose arm of IBD98-M
    Arm description
    		 1.2 g/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    IBD98-M
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1.2 g/day, 6 capsules/day

    Arm title
    		 Lower dose arm of IBD98-M
    Arm description
    		 0.8 g/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    IBD98-M low dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.8 g/day, total 4 capsules/day

    Arm title
    		 Placebo
    Arm description
    		 No HA and mesalamine enteric coated pellets filled in a capsule
    Arm type
    		 Placebo

    Investigational medicinal product name
    IBD Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    6 capsules/day

    Number of subjects in period 1
    		High dose arm of IBD98-M Lower dose arm of IBD98-M Placebo
    Started
    16
    17
    18
    Completed
    14
    11
    12
    Not completed
    2
    6
    6
         Consent withdrawn by subject
    1
    2
    -
         Physician decision
    -
    -
    1
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    -
    3
    5
         Protocol deviation
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    High dose arm of IBD98-M
    Reporting group description
    		 1.2 g/day

    Reporting group title
    Lower dose arm of IBD98-M
    Reporting group description
    		 0.8 g/day

    Reporting group title
    Placebo
    Reporting group description
    		 No HA and mesalamine enteric coated pellets filled in a capsule

    Reporting group values
    		 High dose arm of IBD98-M Lower dose arm of IBD98-M Placebo Total
    Number of subjects
    		 16 17 18 51
    Age categorical
    Demographic and baseline characteristics will be summarized using descriptive statistics for each treatment group and overall for the safety population.
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 15 17 17 49
        From 65-84 years
    		 1 0 1 2
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 5 9 23
        Male
    		 7 12 9 28
    Subject analysis sets

    Subject analysis set title
    Subject enroll_ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The safety population will include all randomized patients who receive at least 1 dose of study drug. The treatment group assignment in this population will be defined by the treatment actually received. This population will be used for the analysis of safety.

    Subject analysis sets values
    		 Subject enroll_ITT
    Number of subjects
    51
    Age categorical
    Demographic and baseline characteristics will be summarized using descriptive statistics for each treatment group and overall for the safety population.
    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)
    49
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    23
        Male
    28

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    High dose arm of IBD98-M
    Reporting group description
    		 1.2 g/day

    Reporting group title
    Lower dose arm of IBD98-M
    Reporting group description
    		 0.8 g/day

    Reporting group title
    Placebo
    Reporting group description
    		 No HA and mesalamine enteric coated pellets filled in a capsule

    Subject analysis set title
    Subject enroll_ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The safety population will include all randomized patients who receive at least 1 dose of study drug. The treatment group assignment in this population will be defined by the treatment actually received. This population will be used for the analysis of safety.

    Primary: The percentage of patients in remission at Week 6.

    		 Close Top of page
    End point title
    		 The percentage of patients in remission at Week 6.
    End point description
    To compare the percentage of patients in ulcerative colitis (UC) remission at Week 6 for each of the 2 IBD98-M dose groups versus placebo (remission defined as the modified Ulcerative Colitis Disease Activity Index [UCDAI] score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1)
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 High dose arm of IBD98-M Lower dose arm of IBD98-M Placebo
    Number of subjects analysed
    16
    17
    18
    Units: percentage
    13
    6
    11
    Statistical analysis title
    		 Primary Efficacy Analysis:
    Statistical analysis description
    The percentage of patients in remission at Week 6 is summarized for the ITT population
    Comparison groups
    Lower dose arm of IBD98-M v High dose arm of IBD98-M v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    6 weeks
    Adverse event reporting additional description
    The safety endpoints include: Treatment-Emergent Adverse Events (TEAEs) Serious Adverse Events (SAEs) Physical examination findings Vital signs Clinical laboratory parameters (including chemistry, hematology, coagulation, and urinalysis) Electrocardiograms (ECGs).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    IBD98-M 1.2 g/day
    Reporting group description
    		 1.2 g/day

    Reporting group title
    IBD98-M 0.8 g/day
    Reporting group description
    		 0.8 g/day

    Reporting group title
    Placebo
    Reporting group description
    		 No HA and Mesalamine enteric coated pellets filled in a capsule

    Serious adverse events
    		 IBD98-M 1.2 g/day IBD98-M 0.8 g/day Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IBD98-M 1.2 g/day IBD98-M 0.8 g/day Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious adverse events recorded for these results as the disease of patient is not considered as severe.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2017
    the Substantial Amendment to the IBD98-M-2002 Protocol Amendment 3 dated 09 May 2017 (Amendment Code 201500102242-003), according to the Law Decree n. 211 dated 24 June 2003, the Law Decree n. 200 dated 6 November 2007 and the Law n. 189 dated 8 November 2012.

    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
    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.

    European Medicines Agency © 1995-Fri May 03 14:29:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA