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    Clinical Trial Results:
    Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease

    Summary
    EudraCT number
    2020-005770-99
    Trial protocol
    BE   IE   NL   DK   SE   NO   PT   IT   FR  
    Global end of trial date
    31 May 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jun 2023
    First version publication date
    15 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1368-0059
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05013385
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.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
    26 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Response and / or inducing Radiographic Stenosis Response in patients with symptomatic Crohn’s Disease (CD)-related small bowel stenosis, who have achieved Symptomatic Stenosis Response after standard medical therapy.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Apr 2022
    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
    Canada: 2
    Country: Number of subjects enrolled
    Japan: 1
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    5
    EEA total number of subjects
    1
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was designed to have a Lead-in Period where background medication is optimized, a Randomized Blinded Treatment Period where patients would have been randomized to spesolimab or placebo and a Follow-up Period. The trial was terminated when 5 patients had entered the Lead-in period. No patient was randomized to spesolimab or placebo.

    Pre-assignment
    Screening details
    All subjects who entered the Lead-in period were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

    Period 1
    Period 1 title
    Overall Study (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
    Arm title
    Enrolled patients
    Arm description
    Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial were planned to receive during the Lead-In Period standard medical treatment which included 2 weeks of corticosteroids to be tapered according to a standardized 8 week regimen and individual optimization of anti-inflammatory biological treatment. After 8 weeks of optimized biological anti-inflammatory therapy would have been completed, only patients who would have achieved a Symptomatic Stenosis Response and an absent or mild-to-moderate colonic endoscopic activity (colonic Simple Endoscopic Score in Crohn’s Disease (SES-CD) ≤12) would have been eligible for randomization into the Blinded Treatment Period.
    Arm type
    Optimization of background medication

    Investigational medicinal product name
    Standard of care corticosteroids during the Lead-In period
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Enrolled patients were administered 2 weeks of short-term corticosteroids with subsequent tapering at the beginning of the Lead-in period, i.e. when the patient was enrolled in the acute episode of the disease. No one of the enrolled patients, reached the point of 8-weeks optimized biological treatment during the Lead-In period.

    Number of subjects in period 1
    Enrolled patients
    Started
    5
    Patients in the Blinded Treatment Period
    0
    Completed
    0
    Not completed
    5
         Sponsor's decision to terminate the trial
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Enrolled patients
    Reporting group description
    Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial were planned to receive during the Lead-In Period standard medical treatment which included 2 weeks of corticosteroids to be tapered according to a standardized 8 week regimen and individual optimization of anti-inflammatory biological treatment. After 8 weeks of optimized biological anti-inflammatory therapy would have been completed, only patients who would have achieved a Symptomatic Stenosis Response and an absent or mild-to-moderate colonic endoscopic activity (colonic Simple Endoscopic Score in Crohn’s Disease (SES-CD) ≤12) would have been eligible for randomization into the Blinded Treatment Period.

    Reporting group values
    Enrolled patients Total
    Number of subjects
    5 5
    Age categorical
    Enrolled patients: Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial.
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    5 5
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous
    Enrolled patients: Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial.
    Units: years
        arithmetic mean (standard deviation)
    34.2 ± 10.8 -
    Sex: Female, Male
    Enrolled patients: Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial.
    Units: Participants
        Female
    2 2
        Male
    3 3
    Race (NIH/OMB)
    Enrolled patients: Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial.
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    1 1
        Native Hawaiian or Other Pacific Islander
    0 0
        Black or African American
    0 0
        White
    4 4
        More than one race
    0 0
        Unknown or Not Reported
    0 0
    Ethnicity (NIH/OMB)
    Enrolled patients: Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial.
    Units: Subjects
        Hispanic or Latino
    0 0
        Not Hispanic or Latino
    5 5
        Unknown or Not Reported
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Enrolled patients
    Reporting group description
    Fibrostenotic Crohn’s Disease patients who were eligible to enter the Lead-In period of the trial were planned to receive during the Lead-In Period standard medical treatment which included 2 weeks of corticosteroids to be tapered according to a standardized 8 week regimen and individual optimization of anti-inflammatory biological treatment. After 8 weeks of optimized biological anti-inflammatory therapy would have been completed, only patients who would have achieved a Symptomatic Stenosis Response and an absent or mild-to-moderate colonic endoscopic activity (colonic Simple Endoscopic Score in Crohn’s Disease (SES-CD) ≤12) would have been eligible for randomization into the Blinded Treatment Period.

    Primary: Proportion of patients with maintained Symptomatic Stenosis Response at Week 48

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    End point title
    Proportion of patients with maintained Symptomatic Stenosis Response at Week 48 [1]
    End point description
    Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period.
    End point type
    Primary
    End point timeframe
    At Week 48.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No data could be collected for the primary end point to perform the statistical analyses.
    End point values
    Enrolled patients
    Number of subjects analysed
    0 [2]
    Units: proportion of patients
        number (not applicable)
    Notes
    [2] - No patient entered the Randomized Blinded Treatment Period, therefore no data could be collected.
    No statistical analyses for this end point

    Primary: Proportion of patients with Radiographic Stenosis Response at Week 48

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    End point title
    Proportion of patients with Radiographic Stenosis Response at Week 48 [3]
    End point description
    Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period.
    End point type
    Primary
    End point timeframe
    At week 48.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No data could be collected for the primary end point to perform the statistical analyses.
    End point values
    Enrolled patients
    Number of subjects analysed
    0 [4]
    Units: proportion of patients
        number (not applicable)
    Notes
    [4] - No patient entered the Randomized Blinded Treatment Period, therefore no data could be collected.
    No statistical analyses for this end point

    Secondary: Proportion of patients with Radiographic Stenosis Response at Week 24

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    End point title
    Proportion of patients with Radiographic Stenosis Response at Week 24
    End point description
    Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period.
    End point type
    Secondary
    End point timeframe
    timeframe.
    End point values
    Enrolled patients
    Number of subjects analysed
    0 [5]
    Units: proportion of patients
        number (not applicable)
    Notes
    [5] - No patient entered the Randomized Blinded Treatment Period, therefore no data could be collected.
    No statistical analyses for this end point

    Secondary: Proportion of patients with maintained Symptomatic Stenosis Response at Week 24

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    End point title
    Proportion of patients with maintained Symptomatic Stenosis Response at Week 24
    End point description
    Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period.
    End point type
    Secondary
    End point timeframe
    At Week 24.
    End point values
    Enrolled patients
    Number of subjects analysed
    0 [6]
    Units: proportion of patients
        number (not applicable)
    Notes
    [6] - No patient entered the Randomized Blinded Treatment Period, therefore no data could be collected.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Not applicable.
    Adverse event reporting additional description
    Adverse events data were planned to be reported for the Randomized Blinded Treatment Period. Since no patient was randomised to receive the investigational medical products (spesolimab or placebo), adverse events reporting is not applicable for this study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Non Serious Adverse Events were planned to be reported for the Randomized Blinded Treatment Period. Since no subject entered the Randomized Blinded Treatment Period, reporting of Non-Serious Adverse Events is not applicable for this study.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jun 2021
    Information was added for clarification in the inclusion and exclusion criteria, rephrasing of wording.
    20 Oct 2021
    Addition of permanent trial treatment discontinuation if patient experiences a moderate or severe opportunistic infection, or if a patient experiences any infection that meets serious adverse events (SAE) reporting criteria.

    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.
    Study was terminated early due to sponsor's decision. Outcome measure data could not be collected.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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